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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT04418661
Registration number
NCT04418661
Ethics application status
Date submitted
29/05/2020
Date registered
5/06/2020
Date last updated
29/05/2025
Titles & IDs
Public title
Safety and Efficacy Study of Vociprotafib (SAR442720) in Combination With Other Agents in Advanced Malignancies
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Scientific title
A Phase 1/2, Open-label, Multicenter, Dose Escalation and Dose Expansion Study of SAR442720 in Combination With Other Agents in Participants With Advanced Malignancies
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Secondary ID [1]
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U1111-1244-2555
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Secondary ID [2]
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TCD16210
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Metastatic Neoplasm
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0
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Vociprotafib
Treatment: Drugs - Pembrolizumab
Treatment: Drugs - Adagrasib
Experimental: Part 1- SAR442720 140 mg BIW + Pembrolizumab - Participants were administered SAR442720 140 milligram (mg) orally twice a week (BIW) on Days 1 and 4 along with pembrolizumab 200 mg via intravenous (IV) infusion once every 3 weeks (Q3W) in 21-day cycles until disease progression, unacceptable adverse events (AEs), or the participant's or investigator's decision to stop the treatment.
Experimental: Part 1- SAR442720 200mg BIW + Pembrolizumab - Participants were administered SAR442720 200 mg orally BIW on Days 1 and 2 along with pembrolizumab 200 mg via IV infusion Q3W in 21-day cycles until disease progression, unacceptable AEs, or the participant's or investigator's decision to stop the treatment.
Experimental: Part 2- SAR442720 200mg + Pembrolizumab - Cohort A1 (PDL1 TPS >=50%) - Participants with programmed death-ligand 1 (PD-L1) tumor proportion score (TPS)\>=50% non-small cell lung cancer (NSCLC) were administered SAR442720 200 mg orally BIW on Days 1 and 2 in 21-day cycles along with an IV infusion of pembrolizumab 200 mg on Q3W (21 days cycle) or 400 mg once in every 6 weeks (Q6W) (42 days cycle) until disease progression, unacceptable AEs, consent withdrawal, or the participant's or investigator's decision to stop the treatment.
Experimental: Part 2- SAR442720 200mg + Pembrolizumab - Cohort A2 (PDL1 TPS 1% - 49%) - Participants with PDL1 TPS 1% - 49% NSCLC were administered SAR442720 200 mg orally BIW on Days 1 and 2 in 21-day cycles along with an IV infusion of pembrolizumab 200 mg on Q3W (21 days cycle) or 400 mg Q6W (42 days cycle) until disease progression, unacceptable AEs, consent withdrawal, or the participant's or investigator's decision to stop the treatment.
Experimental: Part 3A- SAR442720 100mg BIW + Adagrasib - Participants were administered SAR442720 100 mg orally BIW on Days 1 and 2 along with adagrasib 400 mg orally twice daily (BID) in 21-day cycles until disease progression, unacceptable AEs, consent withdrawal, or the participant's or investigator's decision to stop the treatment.
Experimental: Part 4- SAR442720 200mg + Pembrolizumab - Participants were administered SAR442720 200 mg orally BIW on Days 1 and 2 in 21-day cycles (as tablet during the first cycle and as capsule from Cycle 2) along with an IV infusion of pembrolizumab 200 mg Q3W (21-day cycle)or 400 mg Q6W (42-day cycle) until disease progression, unacceptable AEs, consent withdrawal, or the participant's or investigator's decision to stop the treatment.
Treatment: Drugs: Vociprotafib
Pharmaceutical form: Varies Route of administration: Varies
Treatment: Drugs: Pembrolizumab
Pharmaceutical form:Sterile Lyophilized powder for reconstitution Route of administration: Infusion
Treatment: Drugs: Adagrasib
Pharmaceutical form:Sterile Tablet Route of administration: Oral
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Part 1: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
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Assessment method [1]
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AE: any untoward medical occurrence in participant or clinical study participant, temporally associated with the use of IMP, whether or not considered related to the IMP. TEAEs: AEs that developed or worsened or became serious during treatment-emergent period, defined as time from first administration of IMP (on Day 1) to last administration of IMP + 30 days. SAE: any untoward medical occurrence that, at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was a medically important event.
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Timepoint [1]
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From first dose of IMP up to 30 days after the last dose; approximately 27 weeks
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Primary outcome [2]
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Parts 1 and 3A: Number of Participants With Treatment Related Dose Limiting Toxicities (DLTs)
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Assessment method [2]
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Potential DLTs were defined as the AEs that occurred during the first cycle (C) of treatment, considered by the investigator to be related to IMP, unless due to disease progression or to a cause obviously unrelated to IMP: Grade(G)\>= 4 AEs, G3 neutropenia lasting \>7 days or febrile neutropenia; G3 thrombocytopenia with clinically significant bleeding; any G\>=3 immune-related AEs; G3 nonhematologic AEs; G3 aspartate transaminase, alanine transaminase, and/or total bilirubin elevations that persist \>5 days; possible Hy's law case; G3 QT interval corrected using Fridericia's formula prolongation; retinal vein occlusion any grade; toxicity related to IMP leading to 50% or less dose intensity of SAR442720 and/or delay in initiation of C2 dosing of pembrolizumab by \>15 days, in the absence of recovery to baseline or G \<=1 AE. Potential DLT were reviewed by Sponsor and investigators to confirm them as DLTs.
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Timepoint [2]
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Cycle 1 (21 days)
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Primary outcome [3]
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Part 2: Percentage of Participants With Objective Response Rate (ORR)
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Assessment method [3]
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ORR was defined as the percentage of participants who had a confirmed complete response (CR) or partial response (PR) determined by investigator per response evaluation criteria in solid tumors (RECIST) version 1.1 CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or nontarget) had reduction in short axis to 10 millimeter (mm) OR disappearance of all nontarget lesions and normalization of tumor marker level. All lymph nodes had nonpathological in size (\< 10 mm short axis). PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. The confidence interval (CI) was estimated using Clopper-Pearson method.
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Timepoint [3]
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Tumor assessments performed every 9 weeks (56 ±7 days) after the date of first IMP up to end of treatment, approximately 107 weeks
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Primary outcome [4]
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Part 3A: Number of Participants With Treatment-Emergent Adverse Events and Treatment-Emergent Serious Adverse Events
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Assessment method [4]
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AE: any untoward medical occurrence in participant or clinical study participant, temporally associated with the use of IMP, whether or not considered related to the IMP. TEAEs: AEs that developed or worsened or became serious during treatment-emergent period, defined as time from first administration of IMP (on Day 1) to last administration of IMP + 30 days. SAE: any untoward medical occurrence that, at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was a medically important event.
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Timepoint [4]
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From first dose of IMP up to 30 days after the last dose; approximately 7 weeks
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Primary outcome [5]
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Part 4: Plasma Concentration of SAR442720 in Combination With Pembrolizumab
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Assessment method [5]
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Plasma samples were collected at specified timepoints for pharmacokinetic (PK) analysis.
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Timepoint [5]
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Pre-dose, 0.5, 1, 2, 4, 8, 24 hours post-dose on C1 D1, C1 D15, C2 D1; Pre-dose on C1 D8 and C6 D1; end of treatment (Week 45)
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Primary outcome [6]
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Part 4: Area Under Curve From Zero to Last Concentration Timepoint (AUClast) for SAR442720 Tablets and Capsules
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Assessment method [6]
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Plasma samples were collected at specified timepoints to determine AUClast for evaluating the impact of food and formulation on the PK of SAR442720 tablet. It was calculated using non-compartmental analysis (NCA) method.
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Timepoint [6]
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Pre-dose, 0.5, 1, 2, 4, 8, 24 hours on C1 D1, C1 D15 and C2D1
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Primary outcome [7]
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Part 4: Maximum Observed Plasma Concentration (Cmax) for SAR442720 Tablets and Capsules
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Assessment method [7]
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Plasma samples were collected at specified timepoints to determine Cmax for evaluating the impact of food and formulation on the PK of SAR442720 tablet. It was calculated using NCA method.
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Timepoint [7]
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Pre-dose, 0.5, 1, 2, 4, 8, 24 hours on C1 D1, C1 D15 and C2 D1
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Primary outcome [8]
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Part 4: Time to Reach Maximum Plasma Concentration (Tmax) for SAR442720 Tablets and Capsules
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Assessment method [8]
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Plasma samples were collected at specified timepoints to determine tmax for evaluating the impact of food and formulation on the PK of SAR442720 tablet. It was calculated using NCA method.
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Timepoint [8]
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Pre-dose, 0.5, 1, 2, 4, 8, 24 hours on C1 D1, C1 D15 and C2 D1
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Secondary outcome [1]
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Part 1: Plasma Concentration of SAR442720
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Assessment method [1]
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Plasma samples were collected at specified timepoints for evaluation of SAR442720 PK concentrations.
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Timepoint [1]
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Pre-dose, 2, 8, hours post-dose on C1 D1 and C2D1; pre-dose C1D8, C1D15, and C6D1; 2 hours C2D2; and end of treatment (Week 22)
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Secondary outcome [2]
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Part 2: Plasma Concentration of SAR442720
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Assessment method [2]
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Plasma samples were collected at specified timepoints for evaluation of SAR442720 PK concentrations.
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Timepoint [2]
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Pre-dose and 2 hours post-dose C1D1 and C2D1; pre-dose on C1D8, C1D15, C6D1; and end of treatment (Week 104)
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Secondary outcome [3]
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Parts 1 and 2: Serum Concentration of Pembrolizumab
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Assessment method [3]
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Serum samples were collected at specified timepoints for evaluation of pembrolizumab PK concentrations.
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Timepoint [3]
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Pre-dose and post-dose C1D1; pre-dose on C2D1 and C6D1
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Secondary outcome [4]
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Parts 1 and 4: Percentage of Participants With Objective Response Rate
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Assessment method [4]
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ORR was defined as the percentage of participants who had a confirmed CR or PR determined by investigator per RECIST version 1.1 CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or nontarget) had reduction in short axis to 10 mm OR disappearance of all nontarget lesions and normalization of tumor marker level. All lymph nodes had nonpathological in size (\< 10 mm short axis). PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. The CI was estimated using Clopper-Pearson method.
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Timepoint [4]
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Tumor assessments performed on C3 D1 (± 7 days) and every 2 cycles up to C7 D1 (± 7 days), and then every 3 cycles thereafter, approximately 23.7 weeks (Part 1), 46 weeks (Part 4)
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Secondary outcome [5]
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Part 1: Duration of Response (DoR)
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Assessment method [5]
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DoR as per RECIST version 1.1 was defined as the interval from the first documentation of CR or PR to the earlier of first documentation of definitive disease progression(PD) or death due to any cause, whichever occurs first. CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or nontarget) had reduction in short axis to 10 mm OR disappearance of all nontarget lesions and normalization of tumor marker level. All lymph nodes had nonpathological in size (\< 10 mm short axis). PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study and the sum must also demonstrate an absolute increase of at least 5 mm. DoR was estimated using Kaplan-Meier method.
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Timepoint [5]
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Tumor assessments performed on C3 D1 (± 7 days) and every 2 cycles up to C7 D1 (± 7 days), and then every 3 cycles thereafter, approximately 23.7 weeks
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Secondary outcome [6]
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Part 2: Duration of Response
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Assessment method [6]
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DoR as per RECIST version 1.1 was defined as the interval from the first documentation of CR or PR to the earlier of first documentation of definitive PD or death due to any cause, whichever occurs first. CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or nontarget) had reduction in short axis to 10 mm OR disappearance of all nontarget lesions and normalization of tumor marker level. All lymph nodes had nonpathological in size (\< 10 mm short axis). PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study and the sum must also demonstrate an absolute increase of at least 5mm. DoR was estimated using Kaplan-Meier method.
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Timepoint [6]
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Tumor assessments performed every 9 weeks (56 ±7 days) after the date of first IMP up to end of treatment, approximately 107 weeks
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Secondary outcome [7]
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Part 2: Number of Participants With Treatment-Emergent Adverse Events and Treatment-Emergent Serious Adverse Events
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Assessment method [7]
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AE: any untoward medical occurrence in participant or clinical study participant, temporally associated with the use of IMP, whether or not considered related to the IMP. TEAEs: AEs that developed or worsened or became serious during treatment-emergent period, defined as time from first administration of IMP (on Day 1) to last administration of IMP + 30 days. SAE: any untoward medical occurrence that, at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was a medically important event.
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Timepoint [7]
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From first dose of IMP up to 30 days after the last dose; approximately 111 weeks
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Secondary outcome [8]
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Part 4: Number of Participants With Treatment-Emergent Adverse Events and Treatment-Emergent Serious Adverse Events
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Assessment method [8]
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AE: any untoward medical occurrence in participant or clinical study participant, temporally associated with the use of IMP, whether or not considered related to the IMP. TEAEs: AEs that developed or worsened or became serious during treatment-emergent period, defined as time from first administration of IMP (on Day 1) to last administration of IMP + 30 days. SAE: any untoward medical occurrence that, at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was a medically important event.
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Timepoint [8]
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From first dose of IMP up to 30 days after the last dose; approximately 50 weeks
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Secondary outcome [9]
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Part 2: Time to Response (TTR)
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Assessment method [9]
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TTR was defined as the time interval from the administration of first IMP dose to the first documented evidence of PR or CR determined by the Investigator per RECIST version 1.1. CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or nontarget) had reduction in short axis to 10 mm OR disappearance of all nontarget lesions and normalization of tumor marker level. All lymph nodes had nonpathological in size (\< 10 mm short axis). PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. TTR was estimated using Kaplan-Meier method.
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Timepoint [9]
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Tumor assessments performed every 9 weeks (56 ±7 days) after the date of first IMP up to end of treatment, approximately 107 weeks
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Secondary outcome [10]
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Part 2: Percentage of Participants With Clinical Benefit Rate
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Assessment method [10]
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Clinical benefit rate was defined as the percentage of participants with confirmed CR or PR at any time or stable disease (SD) of at least 6 months determined by investigator per RECIST version 1.1. CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or nontarget) had reduction in short axis to 10 mm OR disappearance of all nontarget lesions and normalization of tumor marker level. All lymph nodes had nonpathological in size (\< 10 mm short axis). PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. The CI was estimated using Clopper-Pearson method.
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Timepoint [10]
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Tumor assessments performed every 9 weeks (56 ±7 days) after the date of first IMP up to end of treatment, approximately 107 weeks
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Secondary outcome [11]
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Part 2: Percentage of Participants With Disease Control Rate
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Assessment method [11]
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Disease control rate was defined percentage of participants with confirmed CR or PR or SD as determined by the investigator per RECIST version 1.1. CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or nontarget) had reduction in short axis to 10 mm OR disappearance of all nontarget lesions and normalization of tumor marker level. All lymph nodes had nonpathological in size (\< 10 mm short axis). PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. The CI was estimated using Clopper-Pearson method.
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Timepoint [11]
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Tumor assessments performed every 9 weeks (56 ±7 days) after the date of first IMP up to end of treatment, approximately 107 weeks
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Secondary outcome [12]
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Part 2: Progression Free Survival (PFS)
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Assessment method [12]
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PFS was defined as the time from the date of first IMP administration to the date of the first documented PD determined by the investigator per RECIST version 1.1 or death due to any cause, whichever occurs first. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study and the sum must also demonstrate an absolute increase of at least 5 mm. PFS was estimated using Kaplan-Meier method.
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Timepoint [12]
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Tumor assessments performed every 9 weeks (56 ±7 days) after the date of first IMP up to end of treatment, approximately 107 weeks
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Secondary outcome [13]
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Part 3A: Plasma Concentration of SAR442720
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Assessment method [13]
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Plasma samples were collected at specified timepoints for evaluation of SAR442720 PK concentrations. It was calculated using NCA method.
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Timepoint [13]
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Pre-dose, 0.5, 1, 2, 4, 6, 24 hours post-dose C1D1; pre-dose C1D8; pre-dose, 0.5, 1, 2, 4, 6 post-dose C1D15, and end of treatment (Week 3)
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Secondary outcome [14]
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Part 3A: Plasma Concentration of Adagrasib
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Assessment method [14]
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Plasma samples were collected at specified timepoints for evaluation of adagrasib PK concentrations. It was calculated using NCA method.
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Timepoint [14]
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Pre-dose, 1, 2, 4, 6, 8 post-dose C1D1 and C1D15; pre-dose C1D8
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Secondary outcome [15]
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0
Part 3A: Percentage of Participants With Objective Response Rate
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Assessment method [15]
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ORR was defined as the percentage of participants who had a confirmed CR or PR determined by investigator per RECIST version 1.1 CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or nontarget) had reduction in short axis to 10 mm OR disappearance of all nontarget lesions and normalization of tumor marker level. All lymph nodes had nonpathological in size (\< 10 mm short axis). PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. The CI was estimated using Clopper-Pearson method.
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Timepoint [15]
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Tumor assessments performed till end of treatment, approximately 3 weeks
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Secondary outcome [16]
0
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Part 3A: Duration of Response
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Assessment method [16]
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DoR as per RECIST version 1.1 was defined as the interval from the first documentation of CR or PR to the earlier of first documentation of definitive PD or death due to any cause, whichever occurs first. CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or nontarget) had reduction in short axis to 10 mm OR disappearance of all nontarget lesions and normalization of tumor marker level. All lymph nodes had nonpathological in size (\< 10 mm short axis). PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study and the sum must also demonstrate an absolute increase of at least 5 mm. DoR was estimated using Kaplan-Meier method.
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Timepoint [16]
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Tumor assessments performed till end of treatment, approximately 3 weeks
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Eligibility
Key inclusion criteria
* Participants must be = 18 years of age.
* Histologically proven diagnosis of advanced solid tumors.
* Participants must have one or more of the following molecular aberrations (Part 1): KRAS mutations and amplifications, BRAF Class 3 mutations, or NF1 LOF mutations.
* Participants must have following molecular aberration (Part 3A and 3B): - KRAS G12C mutation.
* At least 1 measurable disease per RECIST 1.1 criteria.
* Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
* Woman of childbearing potential must agree to follow contraceptive guidance.
* Capable of giving signed informed consent.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Predicted life expectancy <3 months.
* Primary central nervous system (CNS) tumors.
* Symptomatic or impending cord compression. Stable CNS disease was allowed.
* History of cerebrovascular stroke or transient ischemic attack within previous 6 months.
* Prior solid organ or hematologic transplant.
* History or current retinal pigment epithelial detachment (RPED), central serous retinopathy, retinal vascular occlusion (RVO), neovascular macular degeneration.
* Any clinically significant cardiac disease.
* Active, known or suspected autoimmune disease.
* History of or current interstitial lung disease or pneumonitis.
* Receipt of a live-virus vaccination within 28 days, viral vaccine that do not contain live virus within 7 days of planned treatment start. Seasonal flu vaccines that do not contain live virus are permitted.
* Known infection with human immunodeficiency virus (HIV), known uncontrolled hepatitis B infection, active tuberculosis, or severe infection requiring parenteral antibiotic treatment.
* Inadequate hematologic, hepatic and renal function.
* Known second malignancy.
* Impairment of gastrointestinal function.
* Any unstable or clinically significant concurrent medical condition that would, in the opinion of the investigator, jeopardize the safety of a participant, impact their expected survival through the end of the study participation, and/or impact their ability to comply with the protocol.
* History of severe allergic reaction to any of the study intervention components.
The above information was not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Other
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Stopped early
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
9/06/2020
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
4/04/2024
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Sample size
Target
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Accrual to date
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Final
65
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
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Recruitment hospital [1]
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Investigational Site Number : 0360002 - Sydney
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Recruitment hospital [2]
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Investigational Site Number : 0360001 - Woolloongabba
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Recruitment hospital [3]
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Investigational Site Number : 0360003 - Melbourne
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Recruitment postcode(s) [1]
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2031 - Sydney
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Recruitment postcode(s) [2]
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4102 - Woolloongabba
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Recruitment postcode(s) [3]
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3084 - Melbourne
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Recruitment outside Australia
Country [1]
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0
United States of America
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State/province [1]
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0
California
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Country [2]
0
0
United States of America
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State/province [2]
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0
Texas
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Country [3]
0
0
Argentina
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State/province [3]
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0
Santa Fe
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Country [4]
0
0
Argentina
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State/province [4]
0
0
Buenos Aires
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Country [5]
0
0
Chile
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State/province [5]
0
0
La Araucanía
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Country [6]
0
0
Chile
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State/province [6]
0
0
Reg Metropolitana De Santiago
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Country [7]
0
0
Chile
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State/province [7]
0
0
Valparaíso
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Country [8]
0
0
Korea, Republic of
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State/province [8]
0
0
Chungcheongbuk-do
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Country [9]
0
0
Korea, Republic of
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State/province [9]
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0
Gyeonggi-do
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Country [10]
0
0
Korea, Republic of
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State/province [10]
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0
Seoul-teukbyeolsi
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Country [11]
0
0
Spain
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State/province [11]
0
0
Madrid
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Country [12]
0
0
Spain
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State/province [12]
0
0
Valencia
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Country [13]
0
0
Taiwan
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State/province [13]
0
0
Tainan City
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Country [14]
0
0
Taiwan
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State/province [14]
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0
Taipei City
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Sanofi
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Address
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Country
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Other collaborator category [1]
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0
Commercial sector/industry
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Name [1]
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Revolution Medicines, Inc.
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Mirati Therapeutics Inc.
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Summary
Brief summary
Primary Objectives: * Part 1 * To characterize the safety and tolerability of SAR442720 in combination with pembrolizumab in participants with advanced solid tumors. * To define the MTD and RP2D for the combination of SAR442720 and pembrolizumab in participants with solid tumors. * Part 2 * To determine the anti-tumor activity of SAR442720 in combination with pembrolizumab. * Part 3A * To define the MTD and RP2D for the combination of SAR442720 and adagrasib in participants with KRAS G12C NSCLC * To characterize the safety and tolerability of SAR442720 in combination with adagrasib in participants with KRAS G12C NSCLC * Part 3B * To determine the anti-tumor activity of SAR442720 in combination with adagrasib in participants with KRAS G12C NSCLC * Part 4 * To evaluate the impact of food on the PK of SAR442720 when dosed with pembrolizumab. * To evaluate the impact of the formulations (formulation 1 and formulation 2) on the PK of SAR442720 when dosed with pembrolizumab. Secondary Objectives: * Part 1 * To assess the PK of SAR442720 with pembrolizumab, and the PK of pembrolizumab with SAR442720. * To estimate the anti-tumor effects of SAR442720 with pembrolizumab. * Part 2 * To assess the safety profile of SAR442720 combined with pembrolizumab. * To assess other indicators of anti-tumor activity. * To assess the PK of SAR442720 with pembrolizumab, and the PK of pembrolizumab with SAR442720. * Part 3A * To characterize the PK of SAR442720 with adagrasib, and the PK of adagrasib with SAR442720. * To estimate the anti-tumor effects of SAR442720 with adagrasib * Part 3B * To assess the safety profile of SAR442720 with adagrasib in participants with KRAS G12C NSCLC. * To assess other indicators of anti-tumor activity. * To assess the PK of SAR442720 with adagrasib, and the PK of adagrasib with SAR442720. * Part 4 * To assess the safety and tolerability of SAR442720 formulations with pembrolizumab * To estimate the anti-tumor effects of SAR442720 with pembrolizumab.
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Trial website
https://clinicaltrials.gov/study/NCT04418661
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Trial related presentations / publications
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Contacts
Principal investigator
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Clinical Sciences & Operations
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Sanofi
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
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When will data be available (start and end dates)?
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How or where can data be obtained?
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What supporting documents are/will be available?
No Supporting Document Provided
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Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/61/NCT04418661/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/61/NCT04418661/SAP_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT04418661
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