Save

The Evaluation of PC14586 in Patients With Advanced Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE)

PHASE1PHASE2RECRUITING

The Phase 2 monotherapy portion of this study is currently enrolling and will evaluate the efficacy of PC14586 (INN rezatapopt). Overall, 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.

Simpliy with AI

Study details:

PC14586 (INN: rezatapopt) is a first-in-class, oral, small molecule p53 reactivator that is selective for the TP53 Y220C mutation. The primary objective of Phase 2 Monotherapy is to evaluate the efficacy of PC14586 (INN: rezatapopt) at the Recommended Phase 2 Dose (RP2D) including the Overall Response Rate (ORR) in the Ovarian Cancer Cohort and the ORR across all cohorts as determined by blinded independent central review. Secondary objectives of Phase 2 are to characterize the safety, pharmacokinetic (PK) properties, quality of life, and other efficacy measures of PC14586 (INN: rezatapopt) at the RP2D.

Enrollment is open for the Phase 2 Monotherapy portion of the study. The primary objective of Phase 1 Monotherapy is to establish the maximum tolerated dose (MTD) and RP2D of PC14586 (INN: rezatapopt). Secondary objectives are to characterize the PK properties, safety and tolerability, and to assess preliminary efficacy including ORR.

Enrollment into Phase 1 Monotherapy is complete. The primary objective of Phase 1b Combination Therapy is to establish the MTD/RP2D of PC14586 (INN: rezatapopt) when administered in combination with pembrolizumab. Secondary objectives of Phase 1b Combination Therapy are to characterize PK, safety and tolerability, and to assess preliminary efficacy of PC14586 (INN: rezatapopt) when administered in combination with pembrolizumab, including ORR.

Enrollment into Phase 1b Combination Therapy is complete.

Simplify with AI

Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

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)

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

Measurable disease

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

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

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)

Simplify with AI

Eligibility

Age eligible for study : 12 and older

Healthy volunteers accepted : No

Gender eligible for study: All

Things to know

Study dates

Study start: 2020-10-29

Primary completion: 2026-03-17

Study completion finish: 2026-07-14

Study type

TREATMENT

Phase

PHASE1

PHASE2

Trial ID

NCT04585750

Intervention or treatment

DRUG: PC14586

DRUG: pembrolizumab

Conditions

• Advanced Solid Tumor
• Metastatic Cancer
• Metastatic Solid Tumor
• Lung Cancer
• Ovarian Cancer
• Endometrial Cancer
• Prostate Cancer
• Colorectal Cancer
• Breast Cancer
• Head and Neck Cancer
• Advanced Malignant Neoplasm
• Other Cancer
• Locally Advanced

Condition: Advanced Solid Tumor, Metastatic Cancer and more
DRUG: PC14586 and other drugs
Camperdown, New South Wales, Australia and more
Sponsor: PMV Pharmaceuticals, Inc

You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

Are you running this trial? If you're a clinic or sponsor, you can claim this study. Claim or learn more.

Find a site

Closest Location:

Chris O'Brien Lifehouse Hospital

Research sites nearby

Select from list below to view details:

Chris O'Brien Lifehouse Hospital
Camperdown, New South Wales, Australia
Flinders Medical Center
Bedford Park, South Australia, Australia
Monash Medical Centre
Clayton, Victoria, Australia
Linear Clinical Research
Nedlands, Western Australia, Australia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/Arm	Intervention/Treatment
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).	DRUG: PC14586 First-in-class, oral, small molecule p53 reactivator selective for the p53 Y220C mutation.
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.	DRUG: PC14586 First-in-class, oral, small molecule p53 reactivator selective for the p53 Y220C mutation.
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.	DRUG: PC14586 First-in-class, oral, small molecule p53 reactivator selective for the p53 Y220C mutation.
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.	DRUG: PC14586 First-in-class, oral, small molecule p53 reactivator selective for the p53 Y220C mutation.
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.	DRUG: PC14586 First-in-class, oral, small molecule p53 reactivator selective for the p53 Y220C mutation.
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.	DRUG: PC14586 First-in-class, oral, small molecule p53 reactivator selective for the p53 Y220C mutation.
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.	DRUG: PC14586 First-in-class, oral, small molecule p53 reactivator selective for the p53 Y220C mutation.
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.	DRUG: PC14586 First-in-class, oral, small molecule p53 reactivator selective for the p53 Y220C mutation.
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.	DRUG: PC14586 First-in-class, oral, small molecule p53 reactivator selective for the p53 Y220C mutation.

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome Time Frame
Phase 1 Monotherapy (Dose Escalation): Determine the number and type of adverse events to characterize the safety of PC14586 (INN: rezatapopt)	Number of participants with treatment related adverse events	40 months
Phase 1 Monotherapy (Dose Escalation): Establish the Recommended Phase 2 Dose (RP2D)	RP2D will be determined using available safety and pharmacokinetics and pharmacodynamics data	30 months
Phase 1 Monotherapy (Dose Escalation): Establish the maximum tolerated dose (MTD) (Phase 1)	Incidence of dose limiting toxicities (DLTs) during the first 28 days of treatment with PC14586 (INN: rezatapopt)	The first 28 days of treatment (Cycle 1) per patient
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	Number of participants with treatment related adverse events	18 months for treatment arm
Phase 1b Combination Therapy (Part 1: Dose Escalation): Establish the maximum tolerated dose (MTD) of PC14586 (INN: rezatapopt) when administered in combination with pembrolizumab	Incidence of dose limiting toxicities (DLTs) during the first 28 days of treatment with PC14586 (INN: rezatapopt)	The first 28 days of combination treatment arm (starting on Day -7) per patient
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	RP2D will be determined using available safety and pharmacokinetics and pharmacodynamics data	18 months
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	Number of participants with treatment related adverse events	12 months for treatment arm
Phase 2 Monotherapy (Dose Expansion): Response rate assessment to evaluate the clinical activity / efficacy of PC14586 (INN: rezatapopt)	Overall response rate in accordance with Response Evaluation Criteria across all cohorts (RECIST) v.1.1 as assessed by independent review	34 months

Secondary outcome

Secondary Outcome Measure	Secondary Outcome Description	Secondary Outcome Time Frame
Phase 1 Monotherapy: PK profile of PC14586 (INN: rezatapopt) - Peak concentration (Cmax)	Pharmacokinetic parameters will be determined by non-compartmental methods using pharmacokinetic profile of PC14586 (INN: rezatapopt)	Approximately 12 months per patient (75 months for Phase 1 and Phase 2)
Phase 1 Monotherapy: PK profile of PC14586 (INN: rezatapopt) - Time of peak concentration (Tmax)	Pharmacokinetic parameters will be determined by non-compartmental methods using pharmacokinetic profile of PC14586 (INN: rezatapopt)	Approximately 12 months per patient (75 months for Phase 1 and Phase 2)
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)	Pharmacokinetic parameters will be determined by non-compartmental methods using pharmacokinetic profile of PC14586 (INN: rezatapopt)	Approximately 12 months per patient (75 months for Phase 1 and Phase 2)
Phase 1 Monotherapy: PK profile of PC14586 (INN: rezatapopt) - Area under the plasma concentration-time curve in one dosing interval (AUCtau)	Pharmacokinetic parameters will be determined by non-compartmental methods using pharmacokinetic profile of PC14586 (INN: rezatapopt)	Approximately 12 months per patient (75 months for Phase 1 and Phase 2)
Phase 1 Monotherapy: PK profile of PC14586 (INN: rezatapopt) - Trough observed concentrations (Ctrough/Ctau)	Pharmacokinetic parameters will be determined by non-compartmental methods using pharmacokinetic profile of PC14586 (INN: rezatapopt)	Approximately 12 months per patient (75 months for Phase 1 and Phase 2)
Phase 1 Monotherapy: Blood plasma assessment to describe the concentration of PC14586 and metabolite (M1) when PC14586 (INN: rezatapopt) is administered orally.	Blood plasma concentration	Approximately 12 months per patient (75 months for Phase 1 and Phase 2)
Phase 1 Monotherapy (Dose Escalation): Overall Response Rate per RECIST v1.1 or PCWG3 modified RECIST v1.1	Evaluation of preliminary anti-tumor activity of PC14586 (INN: rezatapopt) as a single agent	41 months for study (end of Phase 1)
Phase 1 Monotherapy (Dose Escalation): Time to Response per RECIST v1.1 or PCWG3 modified RECIST v1.1	Evaluation of preliminary anti-tumor activity of PC14586 (INN: rezatapopt) as a single agent	41 months for study (end of Phase 1)
Phase 1 Monotherapy (Dose Escalation): Duration of Response per RECIST v1.1 or PCWG3 modified RECIST v1.1	Evaluation of preliminary anti-tumor activity of PC14586 (INN: rezatapopt) as a single agent	41 months for study (end of Phase 1)
Phase 1 Monotherapy (Dose Escalation): Disease Control Rate per RECIST v1.1 or PCWG3 modified RECIST v1.1	Evaluation of preliminary anti-tumor activity of PC14586 (INN: rezatapopt) as a single agent	41 months for study (end of Phase 1)
Phase 1 Monotherapy (Dose Escalation): Progression Free Survival per RECIST v1.1 or PCWG3 modified RECIST v1.1	Evaluation of preliminary anti-tumor activity of PC14586 (INN: rezatapopt) as a single agent	41 months for study (end of Phase 1)
Phase 1 Monotherapy (Dose Escalation): Overall Survival	Evaluation of preliminary anti-tumor activity of PC14586 (INN: rezatapopt) as a single agent	41 months for study (end of Phase 1)
Phase 1b Combination Therapy: PK profile of PC14586 (INN: rezatapopt) in combination with pembrolizumab - Peak concentration (Cmax)	Pharmacokinetic parameters will be determined by non-compartmental methods using pharmacokinetic profile of PC14586 (INN: rezatapopt)	Approximately 12 months per patient (30 months for treatment arm)
Phase 1b Combination Therapy: PK profile of PC14586 (INN: rezatapopt) in combination with pembrolizumab - Time of peak concentration (Tmax)	Pharmacokinetic parameters will be determined by non-compartmental methods using pharmacokinetic profile of PC14586 (INN: rezatapopt)	Approximately 12 months per patient (30 months for treatment arm)
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)	Pharmacokinetic parameters will be determined by non-compartmental methods using pharmacokinetic profile of PC14586 (INN: rezatapopt)	Approximately 12 months per patient (30 months for treatment arm)
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)	Pharmacokinetic parameters will be determined by non-compartmental methods using pharmacokinetic profile of PC14586 (INN: rezatapopt)	Approximately 12 months per patient (30 months for treatment arm)
Phase 1b Combination Therapy: PK profile of PC14586 (INN: rezatapopt) in combination with pembrolizumab - Trough observed concentrations (Ctrough/Ctau)	Pharmacokinetic parameters will be determined by non-compartmental methods using pharmacokinetic profile of PC14586 (INN: rezatapopt)	Approximately 12 months per patient (30 months for treatment arm)
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.	Blood plasma concentration	Approximately 12 months per patient (30 months for treatment arm)
Phase 1b Combination Therapy: Overall Response Rate per RECIST v1.1, iRECIST, or PCWG3 as assessed by Investigator and as assessed by independent review	Evaluation of anti-tumor activity of PC14586 (INN: rezatapopt) in combination with pembrolizumab	30 months for study (end of Phase 1b)
Phase 1b Combination Therapy: Time to Response per RECIST v1.1, iRECIST, or PCWG3 as assessed by Investigator and as assessed by independent review	Evaluation of anti-tumor activity of PC14586 (INN: rezatapopt) in combination with pembrolizumab	30 months for study (end of Phase 1b)
Phase 1b Combination Therapy: Duration of Response per RECIST v1.1, iRECIST, or PCWG3 as assessed by Investigator and as assessed by independent review	Evaluation of anti-tumor activity of PC14586 (INN: rezatapopt) in combination with pembrolizumab	30 months for study (end of Phase 1b)
Phase 1b Combination Therapy: Disease Control Rate per RECIST v1.1, iRECIST, or PCWG3 as assessed by Investigator and as assessed by independent review	Evaluation of anti-tumor activity of PC14586 (INN: rezatapopt) in combination with pembrolizumab	30 months for study (end of Phase 1b)
Phase 1b Combination Therapy: Overall Survival	Evaluation of anti-tumor activity of PC14586 (INN: rezatapopt) in combination with pembrolizumab	30 months for study (end of Phase 1b)
Phase 1b Combination Therapy: Determine the number and type of adverse events to characterize the safety of PC14586 (INN: rezatapopt)	Number of participants with treatment related adverse events	30 months for study (end of Phase 1b)
Phase 1b Combination Therapy: Progression Free Survival per RECIST v1.1, iRECIST, or PCWG3 as assessed by Investigator and as assessed by independent review	Evaluation of anti-tumor activity of PC14586 (INN: rezatapopt) in combination with pembrolizumab	30 months for study (end of Phase 1b)
Phase 2 Monotherapy: PK profile of PC14586 (INN: rezatapopt) - Time of peak concentration (Tmax)	Pharmacokinetic parameters will be determined by non-compartmental methods using pharmacokinetic profile of PC14586 (INN: rezatapopt)	Approximately 12 months per patient (75 months for Phase 1 and Phase 2)
Phase 2 Monotherapy: PK profile of PC14586 (INN: rezatapopt) - Peak concentration (Cmax)	Pharmacokinetic parameters will be determined by non-compartmental methods using pharmacokinetic profile of PC14586 (INN: rezatapopt)	Approximately 12 months per patient (75 months for Phase 1 and Phase 2)
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)	Pharmacokinetic parameters will be determined by non-compartmental methods using pharmacokinetic profile of PC14586 (INN: rezatapopt)	Approximately 12 months per patient (75 months for Phase 1 and Phase 2)
Phase 2 Monotherapy: PK profile of PC14586 (INN: rezatapopt) - Area under the plasma concentration-time curve in one dosing interval (AUCtau)	Pharmacokinetic parameters will be determined by non-compartmental methods using pharmacokinetic profile of PC14586 (INN: rezatapopt)	Approximately 12 months per patient (75 months for Phase 1 and Phase 2)
Phase 2 Monotherapy: PK profile of PC14586 (INN: rezatapopt) - Trough observed concentrations (Ctrough/Ctau)	Pharmacokinetic parameters will be determined by non-compartmental methods using pharmacokinetic profile of PC14586 (INN: rezatapopt)	Approximately 12 months per patient (75 months for Phase 1 and Phase 2)
Phase 2 Monotherapy: Blood plasma assessment to describe the concentration of PC14586 (INN: rezatapopt) and metabolite (M1) when PC14586 (INN: rezatapopt) is administered orally.	Blood plasma concentration	Approximately 12 months per patient (75 months for Phase 1 and Phase 2)
Phase 2 Monotherapy (Dose Expansion): Determine the number and type of adverse events to characterize the safety of PC14586 (INN: rezatapopt)	Number of participants with treatment related adverse events	34 months for study (end of Phase 2)
Phase 2 Monotherapy (Dose Expansion): Overall Response Rate across all cohorts per RECIST v1.1 as assessed by Investigator	Evaluation of anti-tumor activity of PC14586 (INN: rezatapopt) as a single agent	34 months for study (end of Phase 2)
Phase 2 Monotherapy (Dose Expansion): Overall Response Rate in ovarian cancer cohort per RECIST v1.1 as assessed by Investigator	Evaluation of anti-tumor activity of PC14586 (INN: rezatapopt) as a single agent	34 months for study (end of Phase 2)
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	Evaluation of anti-tumor activity of PC14586 (INN: rezatapopt) as a single agent	34 months for study (end of Phase 2)
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	Evaluation of anti-tumor activity of PC14586 (INN: rezatapopt) as a single agent	34 months for study (end of Phase 2)
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	Evaluation of anti-tumor activity of PC14586 (INN: rezatapopt) as a single agent	34 months for study (end of Phase 2)
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	Evaluation of anti-tumor activity of PC14586 (INN: rezatapopt) as a single agent	34 months for study (end of Phase 2)
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	Evaluation of anti-tumor activity of PC14586 (INN: rezatapopt) as a single agent	34 months for study (end of Phase 2)
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	Evaluation of anti-tumor activity of PC14586 (INN: rezatapopt) as a single agent	34 months for study (end of Phase 2)
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	Evaluation of anti-tumor activity of PC14586 (INN: rezatapopt) as a single agent	34 months for study (end of Phase 2)
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	Evaluation of anti-tumor activity of PC14586 (INN: rezatapopt) as a single agent	34 months for study (end of Phase 2)
Phase 2 Monotherapy (Dose Expansion): Overall Survival in ovarian cancer cohort	Evaluation of anti-tumor activity of PC14586 (INN: rezatapopt) as a single agent	34 months for study (end of Phase 2)
Phase 2 Monotherapy (Dose Expansion): Overall Survival across all cohorts	Evaluation of anti-tumor activity of PC14586 (INN: rezatapopt) as a single agent	34 months for study (end of Phase 2)
Phase 2 Monotherapy (Dose Expansion): Quality of life assessment	Changes from baseline in quality of life as measured by a validated instrument, for participants 18 and older	Evaluated at every visit. 34 months for treatment arm (end of Phase 2)

Frequently Asked Questions

Please note: some questions and answers are submitted by anonymous patients or using AI, and have not been verified by Clinrol

No questions submitted. Be the first to ask a question!

You may be eligible to participate in this trial based on your search.Apply for study

Are you running this trial? If you're a clinic or sponsor, you can claim this study.Claim this trial

References

Clinical Trials Gov: The Evaluation of PC14586 in Patients With Advanced Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE)