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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT04074759
Registration number
NCT04074759
Ethics application status
Date submitted
13/08/2019
Date registered
30/08/2019
Date last updated
23/01/2025
Titles & IDs
Public title
FPT155 in Patients With Advanced Solid Tumors
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Scientific title
A Phase 1a/1b Study of FPT155 in Patients With Advanced Solid Tumors
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Secondary ID [1]
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FPT155-001
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Universal Trial Number (UTN)
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Trial acronym
FPT155-001
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Advanced Solid Tumors
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Other - FPT155
Treatment: Other - pembrolizumab
Experimental: FPT155 monotherapy - The study consists of dose escalation and cohort expansions
Experimental: FPT155 in combination with pembrolizumab - The study consists of dose escalation and cohort expansions
Treatment: Other: FPT155
A soluble CD80 fusion protein
Treatment: Other: pembrolizumab
An anti-PD1 antibody
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Intervention code [1]
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Treatment: Other
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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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Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs)
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Assessment method [1]
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TEAE was defined as an adverse event (AE) that was not present prior to the start date of study drug or was worsened during treatment and 100 days after last dose of treatment. An AE that was present at treatment initiation but resolved and then reappeared and the event severity increase while the participant was on treatment is also a TEAE. A severe AE (SAE) is defined as any untoward medical occurrence that at any dose: Is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, and is a congenital anomaly/birth defect. AEs were graded 1 (mild)-5 (fatal AE) according to the National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI-CTCAE) Version 4.03.
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Timepoint [1]
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Median (min, max) duration of FPT155 exposure was 6.57 [3.0, 49.6] weeks for the Phase 1a Monotherapy part of the study, 8.29 [3.0, 27.1] weeks for the Phase 1b Monotherapy, and 14.71 [3.0, 25.1] weeks for the Phase 1a Combination
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Primary outcome [2]
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Phase 1a Monotherapy: Number of Participants Who Experienced Dose Limiting Toxicities (DLTs)
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Assessment method [2]
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DLTs ware defined as any of the events that occurred during the first 28 days of treatment and were assessed by the Clinical Research Coordinator (CRC) as related to FPT155.
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Timepoint [2]
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Cycle 1 (one cycle = 21 days) Day 1 post-dose, up to approximately 21 days
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Primary outcome [3]
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Phase 1b Monotherapy: Number of Participants Who Had FPT155 Treatment Discontinued Due to AEs
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Assessment method [3]
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Represents the number of participants who had discontinuation of FPT155 dosing due to AEs.
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Timepoint [3]
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Median (min, max) duration of FPT155 exposure was 8.29 [3.0, 27.1] weeks.
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Primary outcome [4]
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Phase 1b Monotherapy: Number of Participants Who Had FPT155 Treatment Modified Due to AEs
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Assessment method [4]
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Represents the number of participants who had a modification in the dosing schedules of FPT155 due to AEs.
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Timepoint [4]
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Median (min, max) duration of FPT155 exposure was 8.29 [3.0, 27.1] weeks.
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Primary outcome [5]
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Phase 1b Monotherapy: Number of Participants Who Had FPT155 Treatment Interrupted Due to AEs
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Assessment method [5]
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Represents the number of participants who had an interruption in the dosing schedules of FPT155 due to AEs.
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Timepoint [5]
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Median (min, max) duration of FPT155 exposure was 8.29 [3.0, 27.1] weeks.
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Primary outcome [6]
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Phase 1a Combination: Number of Participants Who Experienced DLTs
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Assessment method [6]
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DLTs ware defined as any of the events that occur during the first 28 days of treatment and are assessed by the CRC as related to FPT155.
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Timepoint [6]
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Cycle 1 (one cycle = 21 days) Day 1 post-dose, up to approximately 21 days
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Secondary outcome [1]
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Phase 1a Monotherapy: Area Under Serum Concentration-time Profile From Time 0 to Time Tau (The Dosing Interval) (AUC0-tau) of FPT155
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Assessment method [1]
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Timepoint [1]
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Cycle 1 (21-day cycles) Day 1 pre-dose, Day 1 (15min, 1h, 2h, 6h post-dose), Day 2, Day 4, Day 8, Day 15
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Secondary outcome [2]
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Phase 1a Monotherapy: Maximum Observed Serum Concentration (Cmax) of FPT155
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Assessment method [2]
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Timepoint [2]
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Cycle 1 (21-day cycles) Day 1 pre-dose, Day 1 (15min, 1h, 2h, 6h post-dose), Day 2, Day 4, Day 8, Day 15
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Secondary outcome [3]
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Phase 1a Monotherapy: Trough Observed Serum Concentration at the End of Each Dose Interval (Ctrough) of FPT155
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Assessment method [3]
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Timepoint [3]
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Cycle 1 (21-day cycles) Day 1 pre-dose, Day 1 (15min, 1h, 2h, 6h post-dose), Day 2, Day 4, Day 8, Day 15
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Secondary outcome [4]
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Phase 1a Monotherapy: Clearance (CL) of FPT155
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Assessment method [4]
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Timepoint [4]
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Cycle 1 (21-day cycles) Day 1 pre-dose, Day 1 (15min, 1h, 2h, 6h post-dose), Day 2, Day 4, Day 8, Day 15
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Secondary outcome [5]
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Phase 1a Monotherapy: Terminal Half-life (t1/2) of FPT155
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Assessment method [5]
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Timepoint [5]
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Cycle 1 (21-day cycles) Day 1 pre-dose, Day 1 (15min, 1h, 2h, 6h post-dose), Day 2, Day 4, Day 8, Day 15
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Secondary outcome [6]
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Phase 1a Monotherapy: Volume of Distribution at Steady State (Vss) of FPT155
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Assessment method [6]
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Timepoint [6]
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Cycle 1 (21-day cycles) Day 1 pre-dose, Day 1 (15min, 1h, 2h, 6h post-dose), Day 2, Day 4, Day 8, Day 15
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Secondary outcome [7]
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Phase 1a Monotherapy: Number of Participants With Treatment-emergent Anti-FPT155 Antibody Response
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Assessment method [7]
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Data presented below includes participants with at least 1 anti-drug antibodies-positive sample relative to baseline after initiation of the treatment.
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Timepoint [7]
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Cycle 1 (21-day cycles) Day 1
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Secondary outcome [8]
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Phase 1b Monotherapy: Objective Response Rate (ORR) Per RECIST v1.1
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Assessment method [8]
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ORR was defined as the total number of participants with confirmed responses of either complete response (CR) (CR: The disappearance of all target lesions, any pathological lymph nodes \[whether target or non-target\] must have a reduction in short axis to \<10 mm) or partial response (PR) (PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters), as determined by the investigator per RECIST v1.1.
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Timepoint [8]
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Up to approximately 30 months
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Secondary outcome [9]
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Phase 1b Monotherapy: Duration of Response (DOR) Per RECIST v1.1
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Assessment method [9]
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DOR was defined as the time from first response (CR \[The disappearance of all target lesions, any pathological lymph nodes {whether target or non-target} or PR \[At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters\] determined by the investigator per RECIST v1.1) that was subsequently confirmed until the onset of progressive disease (DP) (DP: At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study \[this includes the baseline sum if that is the smallest on study\]. In addition to the 20% relative increase, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression) or death from any cause, whichever occurred first.
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Timepoint [9]
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Up to approximately 30 months
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Secondary outcome [10]
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Phase 1b Monotherapy: Progression-free Survival (PFS) Per RECIST v1.1
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Assessment method [10]
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PFS was defined as time from the first dose of study treatment until the first documentation by the investigator of DP (DP: At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study \[this includes the baseline sum if that is the smallest on study\]. In addition to the 20% relative increase, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression) per RECIST v1.1 or death from any cause, whichever occurred first. The median was estimated by using the Kaplan-Meier method and corresponding 2-sided 90% CI using Brookmeyer and Crowley methodology.
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Timepoint [10]
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Up to approximately 30 months
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Secondary outcome [11]
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Phase 1b Monotherapy: Disease Control Rate (DCR) Per RECIST v1.1
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Assessment method [11]
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DCR was defined as the total number of participants with confirmed responses of either CR (CR: The disappearance of all target lesions, any pathological lymph nodes \[whether target or non-target\] must have a reduction in short axis to \<10 mm), PR (PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters), or stable disease (SD) (SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. In numerical terms, it means a reduction in tumor size that is less than 30% \[which is required for PR\] and an increase in size that is less than 20% \[which is required for PD\]) as determined by the investigator per RECIST v1.1.
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Timepoint [11]
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Up to approximately 30 months
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Secondary outcome [12]
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Phase 1b Monotherapy: AUC0-tau of FPT155
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Assessment method [12]
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Timepoint [12]
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Cycle 1 (21-day cycles) Day 1 pre-dose, Day 1 (15min, 1h, 2h, 6h post-dose), Day 2, Day 4, Day 8, Day 15
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Secondary outcome [13]
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Phase 1b Monotherapy: Cmax of FPT155
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Assessment method [13]
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Timepoint [13]
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Cycle 1 (21-day cycles) Day 1 pre-dose, Day 1 (15min, 1h, 2h, 6h post-dose), Day 2, Day 4, Day 8, Day 15
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Secondary outcome [14]
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Phase 1b Monotherapy: Ctrough of FPT155
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Assessment method [14]
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Timepoint [14]
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Cycle 1 (21-day cycles) Day 1 pre-dose, Day 1 (15min, 1h, 2h, 6h post-dose), Day 2, Day 4, Day 8, Day 15
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Secondary outcome [15]
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Phase 1b Monotherapy: CL of FPT155
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Assessment method [15]
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Timepoint [15]
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Cycle 1 (21-day cycles) Day 1 pre-dose, Day 1 (15min, 1h, 2h, 6h post-dose), Day 2, Day 4, Day 8, Day 15
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Secondary outcome [16]
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Phase 1b Monotherapy: t1/2 of FPT155
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Assessment method [16]
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Timepoint [16]
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Cycle 1 (21-day cycles) Day 1 pre-dose, Day 1 (15min, 1h, 2h, 6h post-dose), Day 2, Day 4, Day 8, Day 15
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Secondary outcome [17]
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Phase 1b Monotherapy: Vss of FPT155
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Assessment method [17]
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Timepoint [17]
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Cycle 1 (21-day cycles) Day 1 pre-dose, Day 1 (15min, 1h, 2h, 6h post-dose), Day 2, Day 4, Day 8, Day 15
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Secondary outcome [18]
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Phase 1b Monotherapy: Number of Participants With Treatment-emergent Anti-FPT155 Antibody Response
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Assessment method [18]
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Data presented below includes participants with at least 1 anti-drug antibodies-positive sample relative to baseline after initiation of the treatment.
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Timepoint [18]
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Cycle 1 (21-day cycles) Day 1
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Secondary outcome [19]
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Phase 1a Combination: ORR Per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
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Assessment method [19]
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ORR was defined as the total number of participants with confirmed responses of either CR (CR: The disappearance of all target lesions, any pathological lymph nodes \[whether target or non-target\] must have a reduction in short axis to \<10 mm) or PR (PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters), as determined by the investigator per RECIST v1.1.
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Timepoint [19]
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Up to approximately 30 months
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Eligibility
Key inclusion criteria
* Histologically confirmed solid tumors (except primary central nervous system tumors). For patients enrolled for treatment with FPT155+pembrolizumab: histologically confirmed non-small cell lung cancer not eligible for curative therapy.
* Disease that is unresectable, locally advanced, or metastatic and has progressed following all standard treatments or is not appropriate for standard treatments
* All patients must have at least one measurable lesion at baseline according to RECIST v1.1
* Availability of archival tumor tissue and consent to provide archival tumor for retrospective biomarker analysis, or consent to undergo a fresh tumor biopsy during screening
* For patients participating in cohort expansions: consent to undergo a mandatory fresh tumor biopsy during screening and on treatment
* ECOG performance status of 0 or 1
* Prior radiotherapy must be completed at least 2 weeks before first dose of study treatment administration. No radiopharmaceuticals (eg, strontium, samarium) within 8 weeks before first dose of study treatment administration.
* Prior surgery that requires general anesthesia must be completed at least 14 days before first dose of study treatment
* Adequate bone marrow, liver and kidney function
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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
* Uncontrolled or significant cardiac disease
* Any uncontrolled medical condition or psychiatric disorder including infection, autoimmune disease, bleeding disorder or symptomatic involvement of the central nervous system
* Treatment with any anti-cancer therapy or participation in another investigational drug or biologics trial within 28 days or = 5 half-lives (whichever is shorter)
* Patients who discontinue prior immune-modulating therapies (including regimens containing an immune agonist or a PD-L1/PD-1 antagonist) due to toxicity or have received treatment within 5 half lives or 90 days
* Pregnancy or breastfeeding
* For patients participating in cohort expansion: Prior treatment with a CTLA-4 antagonist, including ipilimumab and tremelimumab
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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
Single group
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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
18/10/2018
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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
10/08/2021
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Sample size
Target
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Accrual to date
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Final
80
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
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Recruitment hospital [1]
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Chris O'Brien Lifehouse - Camperdown
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Recruitment hospital [2]
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St Vincent's Hospital Sydney - Darlinghurst
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Recruitment hospital [3]
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Scientia Clinical Research - Randwick
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Recruitment hospital [4]
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ICON - Auchenflower
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Recruitment hospital [5]
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Olivia Newton-John Cancer Center - Heidelberg
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Recruitment hospital [6]
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Cabrini Hospital - Malvern
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Recruitment hospital [7]
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Linear Clinical Research - Nedlands
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Recruitment postcode(s) [1]
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2050 - Camperdown
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Recruitment postcode(s) [2]
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2010 - Darlinghurst
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Recruitment postcode(s) [3]
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2031 - Randwick
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Recruitment postcode(s) [4]
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4066 - Auchenflower
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Recruitment postcode(s) [5]
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3084 - Heidelberg
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Recruitment postcode(s) [6]
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3144 - Malvern
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Recruitment postcode(s) [7]
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6009 - Nedlands
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Recruitment outside Australia
Country [1]
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Korea, Republic of
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State/province [1]
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Gyeonggi-do
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Country [2]
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Korea, Republic of
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State/province [2]
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Seoul
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Five Prime Therapeutics, Inc.
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
This study is a Phase 1 open-label, first-in-human, multicenter study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and activity of FPT155 as monotherapy in patients with advanced solid tumors.
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Trial website
https://clinicaltrials.gov/study/NCT04074759
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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MD
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Address
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Amgen
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/59/NCT04074759/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/59/NCT04074759/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/NCT04074759
Download to PDF