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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04585750




Registration number
NCT04585750
Ethics application status
Date submitted
1/10/2020
Date registered
14/10/2020
Date last updated
6/06/2024

Titles & IDs
Public title
The Evaluation of PC14586 in Patients With Advanced Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE)
Scientific title
A Phase 1/2 Open-label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of PC14586 in Patients With Locally Advanced or Metastatic Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE)
Secondary ID [1] 0 0
KEYNOTE-D79
Secondary ID [2] 0 0
PMV-586-101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced Solid Tumor 0 0
Advanced Malignant Neoplasm 0 0
Metastatic Cancer 0 0
Metastatic Solid Tumor 0 0
Lung Cancer 0 0
Ovarian Cancer 0 0
Endometrial Cancer 0 0
Prostate Cancer 0 0
Colorectal Cancer 0 0
Breast Cancer 0 0
Other Cancer 0 0
Locally Advanced 0 0
Head and Neck Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Womb (Uterine or endometrial cancer)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - PC14586
Treatment: Drugs - pembrolizumab

Experimental: Phase 1 Monotherapy Dose Escalation - Multiple dose levels of daily oral PC14586 (INN: rezatapopt) will be evaluated in an escalating manner, to determine the maximum tolerated dose and to ensure sufficient safety experience, pharmacokinetic information, and early evidence of clinical activity of PC14586 (INN: rezatapopt) to recommend a Phase 2 dose (RP2D).

Experimental: Phase 1b Combination Therapy Dose Escalation, Part 1 - Multiple dose levels of daily oral PC14586 (INN: rezatapopt) in combination with a stable dose of pembrolizumab (200 mg IV q3 weeks) will be evaluated in an escalating manner, to determine the maximum tolerated dose and to ensure sufficient safety experience, pharmacokinetic information, and early evidence of clinical activity of PC14586 to recommend a Phase 2 dose (RP2D) of PC14586 (INN: rezatapopt) when administered in combination with pembrolizumab.

Experimental: Phase 1b Combination Therapy Dose Expansion, PD(L)-1 naive patients - Additional (expansion of) participants will enroll at the RP2D of daily oral PC14586 (INN: rezatapopt) when administered in combination with pembrolizumab (200 mg IV q3 weeks) for continued evaluation. Participants will have advanced solid tumors harboring a p53 Y220C mutation and are PD(L)-1 naive patients.

Experimental: Phase 1b Combination Therapy Dose Expansion, PD(L)-1 relapsed/refractory patients - Additional (expansion of) participants will enroll at the RP2D of daily oral PC14586 (INN: rezatapopt) when administered in combination with pembrolizumab (200 mg IV q3 weeks) for continued evaluation. Participants will have advanced solid tumors harboring a p53 Y220C mutation and are PD(L)-1 relapsed/refractory patients.

Experimental: Phase 2 Monotherapy Dose Expansion, Ovarian Cancer Cohort - Additional (expansion of) participants will dose with 2000 mg daily oral PC14586 (INN: rezatapopt) with food for continued evaluation. Ovarian Cancer Cohort participants will have locally advanced or metastatic ovarian cancer harboring a TP53 Y220C mutation who meet all eligibility criteria and have measurable disease per RECIST 1.1.

Experimental: Phase 2 Monotherapy Dose Expansion, Lung Cancer Cohort - Additional (expansion of) participants will dose with 2000 mg daily oral PC14586 (INN: rezatapopt) with food for continued evaluation. Lung Cancer Cohort participants will have locally advanced or metastatic lung cancer harboring a TP53 Y220C mutation who meet all eligibility criteria and have measurable disease per RECIST 1.1.

Experimental: Phase 2 Monotherapy Dose Expansion, Breast Cancer Cohort - Additional (expansion of) participants will dose with 2000 mg daily oral PC14586 (INN: rezatapopt) with food for continued evaluation. Breast Cancer Cohort participants will have locally advanced or metastatic breast cancer harboring a TP53 Y220C mutation who meet all eligibility criteria and have measurable disease per RECIST 1.1.

Experimental: Phase 2 Monotherapy Dose Expansion, Endometrial Cancer Cohort - Additional (expansion of) participants will dose with 2000 mg daily oral PC14586 (INN: rezatapopt) with food for continued evaluation. Endometrial Cancer Cohort participants will have locally advanced or metastatic endometrial cancer harboring a TP53 Y220C mutation who meet all eligibility criteria and have measurable disease per RECIST 1.1.

Experimental: Phase 2 Monotherapy Dose Expansion, Other Solid Tumors Cohort - Additional (expansion of) participants will dose with 2000 mg daily oral PC14586 (INN: rezatapopt) with food for continued evaluation. Other Solid Tumors Cohort participants will have locally advanced or metastatic solid tumors harboring a TP53 Y220C mutation who meet all eligibility criteria and have measurable disease per RECIST 1.1.


Treatment: Drugs: PC14586
First-in-class, oral, small molecule p53 reactivator selective for the p53 Y220C mutation.

Treatment: Drugs: pembrolizumab
Participants receive pembrolizumab 200 mg by intravenous (IV) infusion over 30 minutes.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Phase 1 Monotherapy (Dose Escalation): Determine the number and type of adverse events to characterize the safety of PC14586 (INN: rezatapopt)
Timepoint [1] 0 0
40 months
Primary outcome [2] 0 0
Phase 1 Monotherapy (Dose Escalation): Establish the Recommended Phase 2 Dose (RP2D)
Timepoint [2] 0 0
30 months
Primary outcome [3] 0 0
Phase 1 Monotherapy (Dose Escalation): Establish the maximum tolerated dose (MTD) (Phase 1)
Timepoint [3] 0 0
The first 28 days of treatment (Cycle 1) per patient
Primary outcome [4] 0 0
Phase 1b Combination Therapy (Part 1: Dose Escalation): Determine the number and type of adverse events to characterize the safety of PC14586 (INN: rezatapopt) when administered in combination with pembrolizumab
Timepoint [4] 0 0
18 months for treatment arm
Primary outcome [5] 0 0
Phase 1b Combination Therapy (Part 1: Dose Escalation): Establish the maximum tolerated dose (MTD) of PC14586 (INN: rezatapopt) when administered in combination with pembrolizumab
Timepoint [5] 0 0
The first 28 days of combination treatment arm (starting on Day -7) per patient
Primary outcome [6] 0 0
Phase 1b Combination Therapy (Part 1: Dose Escalation): Establish the Recommended Phase 2 Dose (RP2D) of PC14586 (INN: rezatapopt) when administered in combination with pembrolizumab
Timepoint [6] 0 0
18 months
Primary outcome [7] 0 0
Phase 1b Combination Therapy (Part 2: Dose Expansion): Determine the number and type of adverse events to characterize the safety of PC14586 (INN: rezatapopt) when administered in combination with pembrolizumab
Timepoint [7] 0 0
12 months for treatment arm
Primary outcome [8] 0 0
Phase 2 Monotherapy (Dose Expansion): Response rate assessment to evaluate the clinical activity / efficacy of PC14586 (INN: rezatapopt)
Timepoint [8] 0 0
34 months
Secondary outcome [1] 0 0
Phase 1 Monotherapy: PK profile of PC14586 (INN: rezatapopt) - Peak concentration (Cmax)
Timepoint [1] 0 0
Approximately 12 months per patient (75 months for Phase 1 and Phase 2)
Secondary outcome [2] 0 0
Phase 1 Monotherapy: PK profile of PC14586 (INN: rezatapopt) - Time of peak concentration (Tmax)
Timepoint [2] 0 0
Approximately 12 months per patient (75 months for Phase 1 and Phase 2)
Secondary outcome [3] 0 0
Phase 1 Monotherapy: PK profile of PC14586 (INN: rezatapopt) - Area under the plasma concentration-time curve from time zero to time of last sampling timepoint (AUC0-t)
Timepoint [3] 0 0
Approximately 12 months per patient (75 months for Phase 1 and Phase 2)
Secondary outcome [4] 0 0
Phase 1 Monotherapy: PK profile of PC14586 (INN: rezatapopt) - Area under the plasma concentration-time curve in one dosing interval (AUCtau)
Timepoint [4] 0 0
Approximately 12 months per patient (75 months for Phase 1 and Phase 2)
Secondary outcome [5] 0 0
Phase 1 Monotherapy: PK profile of PC14586 (INN: rezatapopt) - Trough observed concentrations (Ctrough/Ctau)
Timepoint [5] 0 0
Approximately 12 months per patient (75 months for Phase 1 and Phase 2)
Secondary outcome [6] 0 0
Phase 1 Monotherapy: Blood plasma assessment to describe the concentration of PC14586 and metabolite (M1) when PC14586 (INN: rezatapopt) is administered orally.
Timepoint [6] 0 0
Approximately 12 months per patient (75 months for Phase 1 and Phase 2)
Secondary outcome [7] 0 0
Phase 1 Monotherapy (Dose Escalation): Overall Response Rate per RECIST v1.1 or PCWG3 modified RECIST v1.1
Timepoint [7] 0 0
41 months for study (end of Phase 1)
Secondary outcome [8] 0 0
Phase 1 Monotherapy (Dose Escalation): Time to Response per RECIST v1.1 or PCWG3 modified RECIST v1.1
Timepoint [8] 0 0
41 months for study (end of Phase 1)
Secondary outcome [9] 0 0
Phase 1 Monotherapy (Dose Escalation): Duration of Response per RECIST v1.1 or PCWG3 modified RECIST v1.1
Timepoint [9] 0 0
41 months for study (end of Phase 1)
Secondary outcome [10] 0 0
Phase 1 Monotherapy (Dose Escalation): Disease Control Rate per RECIST v1.1 or PCWG3 modified RECIST v1.1
Timepoint [10] 0 0
41 months for study (end of Phase 1)
Secondary outcome [11] 0 0
Phase 1 Monotherapy (Dose Escalation): Progression Free Survival per RECIST v1.1 or PCWG3 modified RECIST v1.1
Timepoint [11] 0 0
41 months for study (end of Phase 1)
Secondary outcome [12] 0 0
Phase 1 Monotherapy (Dose Escalation): Overall Survival
Timepoint [12] 0 0
41 months for study (end of Phase 1)
Secondary outcome [13] 0 0
Phase 1b Combination Therapy: PK profile of PC14586 (INN: rezatapopt) in combination with pembrolizumab - Peak concentration (Cmax)
Timepoint [13] 0 0
Approximately 12 months per patient (30 months for treatment arm)
Secondary outcome [14] 0 0
Phase 1b Combination Therapy: PK profile of PC14586 (INN: rezatapopt) in combination with pembrolizumab - Time of peak concentration (Tmax)
Timepoint [14] 0 0
Approximately 12 months per patient (30 months for treatment arm)
Secondary outcome [15] 0 0
Phase 1b Combination Therapy: PK profile of PC14586 (INN: rezatapopt) in combination with pembrolizumab - Area under the plasma concentration-time curve from time zero to time of last sampling timepoint (AUC0-t)
Timepoint [15] 0 0
Approximately 12 months per patient (30 months for treatment arm)
Secondary outcome [16] 0 0
Phase 1b Combination Therapy: PK profile of PC14586 (INN: rezatapopt) in combination with pembrolizumab - Area under the plasma concentration-time curve in one dosing interval (AUCtau)
Timepoint [16] 0 0
Approximately 12 months per patient (30 months for treatment arm)
Secondary outcome [17] 0 0
Phase 1b Combination Therapy: PK profile of PC14586 (INN: rezatapopt) in combination with pembrolizumab - Trough observed concentrations (Ctrough/Ctau)
Timepoint [17] 0 0
Approximately 12 months per patient (30 months for treatment arm)
Secondary outcome [18] 0 0
Phase 1b Combination Therapy: Blood plasma assessment to describe the concentration of PC14586 (INN: rezatapopt) and metabolite (M1) when PC14586 (INN: rezatapopt) is administered orally in combination with pembrolizumab.
Timepoint [18] 0 0
Approximately 12 months per patient (30 months for treatment arm)
Secondary outcome [19] 0 0
Phase 1b Combination Therapy: Overall Response Rate per RECIST v1.1, iRECIST, or PCWG3 as assessed by Investigator and as assessed by independent review
Timepoint [19] 0 0
30 months for study (end of Phase 1b)
Secondary outcome [20] 0 0
Phase 1b Combination Therapy: Time to Response per RECIST v1.1, iRECIST, or PCWG3 as assessed by Investigator and as assessed by independent review
Timepoint [20] 0 0
30 months for study (end of Phase 1b)
Secondary outcome [21] 0 0
Phase 1b Combination Therapy: Duration of Response per RECIST v1.1, iRECIST, or PCWG3 as assessed by Investigator and as assessed by independent review
Timepoint [21] 0 0
30 months for study (end of Phase 1b)
Secondary outcome [22] 0 0
Phase 1b Combination Therapy: Disease Control Rate per RECIST v1.1, iRECIST, or PCWG3 as assessed by Investigator and as assessed by independent review
Timepoint [22] 0 0
30 months for study (end of Phase 1b)
Secondary outcome [23] 0 0
Phase 1b Combination Therapy: Overall Survival
Timepoint [23] 0 0
30 months for study (end of Phase 1b)
Secondary outcome [24] 0 0
Phase 1b Combination Therapy: Determine the number and type of adverse events to characterize the safety of PC14586 (INN: rezatapopt)
Timepoint [24] 0 0
30 months for study (end of Phase 1b)
Secondary outcome [25] 0 0
Phase 1b Combination Therapy: Progression Free Survival per RECIST v1.1, iRECIST, or PCWG3 as assessed by Investigator and as assessed by independent review
Timepoint [25] 0 0
30 months for study (end of Phase 1b)
Secondary outcome [26] 0 0
Phase 2 Monotherapy: PK profile of PC14586 (INN: rezatapopt) - Time of peak concentration (Tmax)
Timepoint [26] 0 0
Approximately 12 months per patient (75 months for Phase 1 and Phase 2)
Secondary outcome [27] 0 0
Phase 2 Monotherapy: PK profile of PC14586 (INN: rezatapopt) - Peak concentration (Cmax)
Timepoint [27] 0 0
Approximately 12 months per patient (75 months for Phase 1 and Phase 2)
Secondary outcome [28] 0 0
Phase 2 Monotherapy: PK profile of PC14586 (INN: rezatapopt) - Area under the plasma concentration-time curve from time zero to time of last sampling timepoint (AUC0-t)
Timepoint [28] 0 0
Approximately 12 months per patient (75 months for Phase 1 and Phase 2)
Secondary outcome [29] 0 0
Phase 2 Monotherapy: PK profile of PC14586 (INN: rezatapopt) - Area under the plasma concentration-time curve in one dosing interval (AUCtau)
Timepoint [29] 0 0
Approximately 12 months per patient (75 months for Phase 1 and Phase 2)
Secondary outcome [30] 0 0
Phase 2 Monotherapy: PK profile of PC14586 (INN: rezatapopt) - Trough observed concentrations (Ctrough/Ctau)
Timepoint [30] 0 0
Approximately 12 months per patient (75 months for Phase 1 and Phase 2)
Secondary outcome [31] 0 0
Phase 2 Monotherapy: Blood plasma assessment to describe the concentration of PC14586 (INN: rezatapopt) and metabolite (M1) when PC14586 (INN: rezatapopt) is administered orally.
Timepoint [31] 0 0
Approximately 12 months per patient (75 months for Phase 1 and Phase 2)
Secondary outcome [32] 0 0
Phase 2 Monotherapy (Dose Expansion): Determine the number and type of adverse events to characterize the safety of PC14586 (INN: rezatapopt)
Timepoint [32] 0 0
34 months for study (end of Phase 2)
Secondary outcome [33] 0 0
Phase 2 Monotherapy (Dose Expansion): Overall Response Rate across all cohorts per RECIST v1.1 as assessed by Investigator
Timepoint [33] 0 0
34 months for study (end of Phase 2)
Secondary outcome [34] 0 0
Phase 2 Monotherapy (Dose Expansion): Overall Response Rate in ovarian cancer cohort per RECIST v1.1 as assessed by Investigator
Timepoint [34] 0 0
34 months for study (end of Phase 2)
Secondary outcome [35] 0 0
Phase 2 Monotherapy (Dose Expansion): Time to Response in ovarian cancer cohort per RECIST v1.1 as assessed by Investigator and as assessed by independent review
Timepoint [35] 0 0
34 months for study (end of Phase 2)
Secondary outcome [36] 0 0
Phase 2 Monotherapy (Dose Expansion): Time to Response across all cohorts per RECIST v1.1 as assessed by Investigator and as assessed by independent review
Timepoint [36] 0 0
34 months for study (end of Phase 2)
Secondary outcome [37] 0 0
Phase 2 Monotherapy (Dose Expansion): Duration of Response in ovarian cancer cohort per RECIST v1.1 as assessed by Investigator and as assessed by independent review
Timepoint [37] 0 0
34 months for study (end of Phase 2)
Secondary outcome [38] 0 0
Phase 2 Monotherapy (Dose Expansion): Duration of Response across all cohorts per RECIST v1.1 as assessed by Investigator and as assessed by independent review
Timepoint [38] 0 0
34 months for study (end of Phase 2)
Secondary outcome [39] 0 0
Phase 2 Monotherapy (Dose Expansion): Disease Control Rate in ovarian cancer cohort per RECIST v1.1 as assessed by Investigator and as assessed by independent review
Timepoint [39] 0 0
34 months for study (end of Phase 2)
Secondary outcome [40] 0 0
Phase 2 Monotherapy (Dose Expansion): Disease Control Rate across all cohorts per RECIST v1.1 as assessed by Investigator and as assessed by independent review
Timepoint [40] 0 0
34 months for study (end of Phase 2)
Secondary outcome [41] 0 0
Phase 2 Monotherapy (Dose Expansion): Progression Free Survival in ovarian cancer cohort per RECIST v1.1 as assessed by Investigator and as assessed by independent review
Timepoint [41] 0 0
34 months for study (end of Phase 2)
Secondary outcome [42] 0 0
Phase 2 Monotherapy (Dose Expansion): Progression Free Survival across all cohorts per RECIST v1.1 as assessed by Investigator and as assessed by independent review
Timepoint [42] 0 0
34 months for study (end of Phase 2)
Secondary outcome [43] 0 0
Phase 2 Monotherapy (Dose Expansion): Overall Survival in ovarian cancer cohort
Timepoint [43] 0 0
34 months for study (end of Phase 2)
Secondary outcome [44] 0 0
Phase 2 Monotherapy (Dose Expansion): Overall Survival across all cohorts
Timepoint [44] 0 0
34 months for study (end of Phase 2)
Secondary outcome [45] 0 0
Phase 2 Monotherapy (Dose Expansion): Quality of life assessment
Timepoint [45] 0 0
Evaluated at every visit. 34 months for treatment arm (end of Phase 2)

Eligibility
Key inclusion criteria
- At least 18 years of age or 12 to 17 years of age after Safety Review Committee
approval.

- Advanced solid malignancy with a TP53 Y220C mutation

- Eastern Cooperative Oncology Group (ECOG) status of 0 or 1

- Previously treated with one or more lines of anticancer therapy and progressive
disease

- Adequate organ function

- Measurable disease per RECIST v1.1 (Phase 2)

Additional Criteria for Inclusion in Phase 1b (PC14586 (INN: rezatapopt) + pembrolizumab
combination)

- Anti-PD-1/PD-L1 naive or must have progressed on treatment

- Measurable disease
Minimum age
12 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Anti-cancer therapy within 21 days (or 5 half-lives) of receiving the study drug

- Radiotherapy within 28 days of receiving the study drug

- Primary CNS tumor

- History of leptomeningeal disease or spinal cord compression

- Brain metastases, unless neurologically stable and do not require steroids to treat
associated neurological symptoms

- Stroke or transient ischemic attack within 6 months prior to screening

- Heart conditions such as unstable angina, uncontrolled hypertension, a heart attack
within 6 months prior to screening, congestive heart failure, prolongation of QT
interval, or other rhythm abnormalities

- Strong CYP3A4 inhibitors or inducers, medications with a known risk of QT/QTc
prolongation, or proton pump inhibitors

- History of gastrointestinal (GI) disease that may interfere with absorption of study
drug or patients unable to take oral medication

- History of prior organ transplant

- Known, active malignancy, except for treated cervical intraepithelial neoplasia, or
non-melanoma skin cancer

- Known, active uncontrolled Hepatitis B, Hepatitis C, or human immunodeficiency virus
infection

Additional Criteria for Exclusion from Phase 2 (PC14586 monotherapy)

- Known KRAS mutation, defined as a single nucleotide variant (SNV) (Phase 2)

Additional Criteria for Exclusion from Phase 1b (PC14586 (INN: rezatapopt) + pembrolizumab
combination)

- Received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an
agent directed to another stimulatory or co-inhibitory T-cell receptor and
discontinued from that treatment due to a Grade 3 or higher immune-related AE (irAE)

- Received a live or live-attenuated vaccine within 30 days prior to the first dose of
study intervention

- Diagnosis of immunodeficiency or receiving chronic systemic steroid therapy within 7
days prior to the first dose of study drug

- Hypersensitivity (= Grade 3) to pembrolizumab and/or any of its excipients

- Active autoimmune disease that has required systemic treatment in past 2 years

- History of radiation pneumonitis

- History of (non-infectious) or active pneumonitis / interstitial lung disease that
required steroids

- Active infection requiring systemic therapy

- Known history of HIV infection

- Has previously received PC14586 (INN: rezatapopt)

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1/Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
29/10/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
14/07/2026
Actual
Sample size
Target
230
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
Recruitment hospital [1] 0 0
Chris O'Brien Lifehouse Hospital - Camperdown
Recruitment hospital [2] 0 0
Monash Medical Centre - Clayton
Recruitment hospital [3] 0 0
Linear Clinical Research - Nedlands
Recruitment postcode(s) [1] 0 0
- Camperdown
Recruitment postcode(s) [2] 0 0
- Clayton
Recruitment postcode(s) [3] 0 0
- Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Connecticut
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Indiana
Country [6] 0 0
United States of America
State/province [6] 0 0
Massachusetts
Country [7] 0 0
United States of America
State/province [7] 0 0
Michigan
Country [8] 0 0
United States of America
State/province [8] 0 0
New York
Country [9] 0 0
United States of America
State/province [9] 0 0
North Carolina
Country [10] 0 0
United States of America
State/province [10] 0 0
Ohio
Country [11] 0 0
United States of America
State/province [11] 0 0
Oklahoma
Country [12] 0 0
United States of America
State/province [12] 0 0
Oregon
Country [13] 0 0
United States of America
State/province [13] 0 0
Pennsylvania
Country [14] 0 0
United States of America
State/province [14] 0 0
South Carolina
Country [15] 0 0
United States of America
State/province [15] 0 0
Tennessee
Country [16] 0 0
United States of America
State/province [16] 0 0
Texas
Country [17] 0 0
United States of America
State/province [17] 0 0
Virginia
Country [18] 0 0
United States of America
State/province [18] 0 0
Washington
Country [19] 0 0
United States of America
State/province [19] 0 0
Wisconsin
Country [20] 0 0
France
State/province [20] 0 0
Bas-Rhin
Country [21] 0 0
France
State/province [21] 0 0
Gironde
Country [22] 0 0
France
State/province [22] 0 0
Haute-Garonne
Country [23] 0 0
France
State/province [23] 0 0
Loire-Atlantique
Country [24] 0 0
France
State/province [24] 0 0
Puy-de-Dôme
Country [25] 0 0
France
State/province [25] 0 0
Val-de-Marne
Country [26] 0 0
France
State/province [26] 0 0
Lyon
Country [27] 0 0
Germany
State/province [27] 0 0
Baden-Württemberg
Country [28] 0 0
Germany
State/province [28] 0 0
Bayern
Country [29] 0 0
Germany
State/province [29] 0 0
Hessen
Country [30] 0 0
Germany
State/province [30] 0 0
Nordrhein-Westfalen
Country [31] 0 0
Germany
State/province [31] 0 0
Hamburg
Country [32] 0 0
Italy
State/province [32] 0 0
Lazio
Country [33] 0 0
Italy
State/province [33] 0 0
Lombardia
Country [34] 0 0
Italy
State/province [34] 0 0
Torino
Country [35] 0 0
Korea, Republic of
State/province [35] 0 0
Seoul
Country [36] 0 0
Singapore
State/province [36] 0 0
Kent Ridge
Country [37] 0 0
Singapore
State/province [37] 0 0
Singapore
Country [38] 0 0
Spain
State/province [38] 0 0
Barcelona
Country [39] 0 0
Spain
State/province [39] 0 0
Madrid
Country [40] 0 0
Spain
State/province [40] 0 0
Valencia
Country [41] 0 0
United Kingdom
State/province [41] 0 0
Middlesex
Country [42] 0 0
United Kingdom
State/province [42] 0 0
Tyne And Wear

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
PMV Pharmaceuticals, Inc
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Merck Sharp & Dohme LLC
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
This Phase 1/2 study will assess the safety, tolerability, and efficacy of multiple dose
levels of PC14586 (INN: rezatapopt) alone (monotherapy) and in combination with pembrolizumab
in participants with advanced solid tumors containing a TP53 Y220C mutation.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04585750
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Marc Fellous, MD
Address 0 0
Vice President of Medical Affairs
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
PMV Pharma Clinical Study Information Center
Address 0 0
Country 0 0
Phone 0 0
(609) 235-4038
Fax 0 0
Email 0 0
clinicaltrials@pmvpharma.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04585750