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Small Molecule

PC14586 for Solid Tumors

Phase 1 & 2
Recruiting
Research Sponsored by PMV Pharmaceuticals, Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
At least 18 years of age or 12 to 17 years of age after adequate adult safety data become available
Adequate organ function
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 12 months per patient (75 months for phase 1 and phase 2)
Awards & highlights

Study Summary

This trial will investigate if a new drug is safe and effective for treating people with solid tumors that have a TP53 Y220C mutation.

Who is the study for?
Adults with advanced solid tumors that have a specific mutation (TP53 Y220C) can join this trial. They should have tried other cancer treatments without success and be in good physical condition (ECOG 0 or 1). People with certain heart conditions, recent strokes, brain metastases needing steroids, or those on drugs affecting the immune system cannot participate.Check my eligibility
What is being tested?
The trial is testing PC14586 alone and combined with pembrolizumab to see how safe and effective they are for treating cancers with the TP53 Y220C mutation. Participants will receive different doses of PC14586 to find out which one works best.See study design
What are the potential side effects?
Possible side effects include reactions at the injection site, fatigue, nausea, skin rash, fever, joint pain from pembrolizumab; plus any additional risks from PC14586 which will be monitored closely due to its newness.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years or older, or between 12 to 17 years with adult safety data available.
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My organs are working well.
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My cancer has worsened despite previous treatments.
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My cancer has a specific TP53 mutation.
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I am fully active or restricted in physically strenuous activity but can do light work.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 12 months per patient (75 months for phase 1 and phase 2)
This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 12 months per patient (75 months for phase 1 and phase 2) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Phase 1 Monotherapy (Dose Escalation): Determine the number and type of adverse events to characterize the safety of PC14586 (INN: rezatapopt)
Phase 1 Monotherapy (Dose Escalation): Establish the Recommended Phase 2 Dose (RP2D)
Phase 1 Monotherapy (Dose Escalation): Establish the maximum tolerated dose (MTD) (Phase 1)
+5 more
Secondary outcome measures
Phase 1 Monotherapy (Dose Escalation): Disease Control Rate per RECIST v1.1 or PCWG3 modified RECIST v1.1
Phase 1 Monotherapy (Dose Escalation): Duration of Response per RECIST v1.1 or PCWG3 modified RECIST v1.1
Phase 1 Monotherapy (Dose Escalation): Overall Response Rate per RECIST v1.1 or PCWG3 modified RECIST v1.1
+42 more

Side effects data

From 2024 Phase 2 trial • 57 Patients • NCT03004183
21%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Kidney Injury and/or Infection
7%
Pneumonia
7%
Dyspnea
7%
Weight Loss
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Activated partial thromboplastin time prolonged
5%
Intractable pain, back pain, hip pain
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Skin rash
2%
Thrombocytopenia
2%
Respiratory failure
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm

Trial Design

9Treatment groups
Experimental Treatment
Group I: Phase 2 Monotherapy Dose Expansion, Ovarian Cancer CohortExperimental Treatment1 Intervention
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.
Group II: Phase 2 Monotherapy Dose Expansion, Other Solid Tumors CohortExperimental Treatment1 Intervention
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.
Group III: Phase 2 Monotherapy Dose Expansion, Lung Cancer CohortExperimental Treatment1 Intervention
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.
Group IV: Phase 2 Monotherapy Dose Expansion, Endometrial Cancer CohortExperimental Treatment1 Intervention
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.
Group V: Phase 2 Monotherapy Dose Expansion, Breast Cancer CohortExperimental Treatment1 Intervention
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.
Group VI: Phase 1b Combination Therapy Dose Expansion, PD(L)-1 relapsed/refractory patientsExperimental Treatment2 Interventions
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.
Group VII: Phase 1b Combination Therapy Dose Expansion, PD(L)-1 naive patientsExperimental Treatment2 Interventions
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.
Group VIII: Phase 1b Combination Therapy Dose Escalation, Part 1Experimental Treatment2 Interventions
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.
Group IX: Phase 1 Monotherapy Dose EscalationExperimental Treatment1 Intervention
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).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
pembrolizumab
2018
Completed Phase 3
~6240
PC14586
2021
Completed Phase 1
~40

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme LLCIndustry Sponsor
3,868 Previous Clinical Trials
5,051,758 Total Patients Enrolled
PMV Pharmaceuticals, IncLead Sponsor
3 Previous Clinical Trials
70 Total Patients Enrolled
Marc Fellous, MDStudy DirectorVice President of Medical Affairs

Media Library

PC14586 (Small Molecule) Clinical Trial Eligibility Overview. Trial Name: NCT04585750 — Phase 1 & 2
Head and Neck Cancers Research Study Groups: Phase 1 Monotherapy Dose Escalation, Phase 1b Combination Therapy Dose Expansion, PD(L)-1 naive patients, Phase 2 Monotherapy Dose Expansion, Ovarian Cancer Cohort, Phase 2 Monotherapy Dose Expansion, Lung Cancer Cohort, Phase 1b Combination Therapy Dose Escalation, Part 1, Phase 2 Monotherapy Dose Expansion, Breast Cancer Cohort, Phase 2 Monotherapy Dose Expansion, Other Solid Tumors Cohort, Phase 1b Combination Therapy Dose Expansion, PD(L)-1 relapsed/refractory patients, Phase 2 Monotherapy Dose Expansion, Endometrial Cancer Cohort
Head and Neck Cancers Clinical Trial 2023: PC14586 Highlights & Side Effects. Trial Name: NCT04585750 — Phase 1 & 2
PC14586 (Small Molecule) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04585750 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

In what number of venues is this experiment currently taking place?

"Currently, 12 sites are administering this trial. These locations span from Nashville to Austin and include several other cities in between. For your convenience, you should select the closest location to avoid extensive travel if you decide to partake."

Answered by AI

Are there any vacancies open to join this clinical experiment?

"Correct. The clinicaltrials.gov website indicates that this medical study, which was initially published on October 29th 2020, is actively recruiting participants. A total of 145 patients need to be recruited from 12 different sites."

Answered by AI

What is the participant capacity of this trial?

"In order to begin the trial, 145 eligible participants need to be enrolled. PMV Pharmaceuticals is managing this research through multiple sites such as Sarah Cannon and HCA Research Institute in Nashville, Tennessee and Memorial Sloan Kettering in New york City."

Answered by AI

What is the ultimate purpose of this investigative project?

"This medical trial has a duration of 48 months, over the course of which two primary outcomes will be assessed: (1) document and classify any adverse effects caused by PC14586; and (2) measure the response rate to evaluate efficacy using RECIST v. 1.1 criteria. Additionally, secondary objectives include gauging changes in quality of life through validated instruments for participants 18 years or older, measuring progression free survival/overall survival rates with RECIST v. 1.1 standards, and assessing preliminary clinical activity / efficacy utilising ORR metrics as well as other response rate assessments."

Answered by AI
~83 spots leftby Mar 2026