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New pill targets rare cancer mutation in early trial

NCT ID NCT04585750

Disease control Sponsor: PMV Pharmaceuticals, Inc Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Sep 16, 2026 · Updated 6 times

Summary

This study tests a new drug called rezatapopt (PC14586) in people with advanced solid tumors that have a specific TP53 Y220C mutation. The drug is designed to reactivate the p53 protein, which normally helps stop cancer growth. The trial will also test rezatapopt combined with the immunotherapy pembrolizumab. About 300 participants will be enrolled to check safety, dosing, and whether the drug shrinks tumors.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
rezatapopt (PC14586) and pembrolizumab
What this could lead to
If successful, this could lead to a new targeted treatment option for people with advanced cancers that have a specific TP53 Y220C mutation, potentially shrinking tumors or slowing disease progression.
What could go wrong
This is an early-phase trial (Phase 1/2) with a small number of participants, so the drug may not work as hoped or could cause unexpected side effects. The mutation is rare, so results may not apply to most cancer patients.
Why investors are watching

PMV Pharmaceuticals runs this trial of rezatapopt, a drug that targets tumors with a specific TP53 Y220C mutation. The study tests whether the drug is safe and can control these tumors, first alone and then combined with pembrolizumab. For a micro-cap company with this as a lead program, the result shapes whether the drug moves forward.

If it works: If rezatapopt controls tumors in these patients, the company could advance the program and attract partners or funding for larger trials.

If it fails: If the drug fails to control tumors or causes safety problems, the program could stall. Most early-stage cancer trials do not succeed, and a small company has few other assets to fall back on.

AI-written from the trial record. Speculative, and not investment advice.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 300 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2020

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

12 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * At least 18 years of age or 12 to 17 years of age after Safety Review Committee approval. * Locally advanced or metastatic 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 (rezatapopt) + pembrolizumab combination) * 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 14 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 within 6 months prior to screening, uncontrolled hypertension, a heart attack within 6 months prior to screening, congestive heart failure, prolongation of QT interval, or other rhythm abnormalities * Strong CYP3A4 inducers and strong CYP2C9 inhibitors/inducers within 14 days of first dose of rezatapopt * 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 (rezatapopt monotherapy) * Known KRAS mutation, defined as a single nucleotide variant (SNV) (Phase 2) Additional Criteria for Exclusion from Phase 1b (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 rezatapopt

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm cancer colorectal cancer colorectal neoplasm endometrial cancer endometrium neoplasm estrogen-receptor positive breast cancer gallbladder cancer gallbladder neoplasm head and neck cancer Head and Neck Neoplasms HER2 positive breast carcinoma Her2-receptor negative breast cancer hormone receptor-positive breast cancer lung cancer lung neoplasm metastatic malignant neoplasm Neoplasm Metastasis non-small cell lung carcinoma ovarian cancer prostate cancer small cell lung carcinoma triple-negative breast carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Advanced malignant neoplasm Advanced solid tumor Breast cancer Colorectal cancer Endometrial cancer ER/PR positive breast cancer ER/PR(+), HER2(-) breast cancer Gall bladder cancer Head and neck cancer HER2 + breast cancer HER2-negative breast cancer HER2-positive breast cancer Locally advanced Lung cancer Metastatic cancer Metastatic solid tumor Non-small cell lung cancer Non-small cell lung carcinoma NSCLC NSCLC (non-small cell lung cancer) Other cancer Ovarian cancer Prostate cancer SCLC Small cell lung cancer Small cell lung cancer ( SCLC ) Small cell lung carcinoma TNBC Triple-negative breast cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    74 sites in 9 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • ASST Grande Ospedale Metropolitano Niguarda

    RECRUITING

    Milan, Lombardy, Italy

  • Abramson Cancer Center of the University of Pennsylvania

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • Advent Health

    RECRUITING

    Orlando, Florida, 32803, United States

  • Asan Medical Center

    RECRUITING

    Seoul, South Korea

  • Asklepios Klinik Altona

    RECRUITING

    Hamburg, Free and Hanseatic City of Hamburg, Germany

  • CHU de Nîmes

    RECRUITING

    Nîmes, 30900, France

  • Centre Jean Perrin

    RECRUITING

    Clermont-Ferrand, Puy-de-Dôme, France

  • Centre Léon Bérard Centre Régional de Lutte Contre Le Cancer

    RECRUITING

    Lyon, France

  • Chris O'Brien Lifehouse Hospital

    RECRUITING

    Camperdown, New South Wales, Australia

  • Columbia University Medical Center

    NOT_YET_RECRUITING

    New York, New York, 10032, United States

  • Dana Farber Cancer Institute

    RECRUITING

    Boston, Massachusetts, 02215, United States

  • Duke University

    RECRUITING

    Durham, North Carolina, 27705, United States

  • EDOG Institut de Cancerologie de l'Ouest

    RECRUITING

    Saint-Herblain, Loire-Atlantique, France

  • Flinders Medical Center

    RECRUITING

    Bedford Park, South Australia, Australia

  • Florida Cancer Specialists South

    RECRUITING

    Port Charlotte, Florida, 33980, United States

  • Fondazione IRCCS Istituto Nazionale Dei Tumori

    RECRUITING

    Milan, Lombardy, Italy

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    RECRUITING

    Rome, Lazio, Italy

  • Fondazione del Piemonte per l'Oncologia (IRCCS)

    RECRUITING

    Candiolo, Torino, Italy

  • Freeman Hospital

    RECRUITING

    Newcastle upon Tyne, Tyne and Wear, United Kingdom

  • Hospital Clinico Universitario de Valencia

    RECRUITING

    Valencia, Spain

  • Hospital Universitario 12 de Octubre

    RECRUITING

    Madrid, 28041, Spain

  • Humanitas San Pio X

    RECRUITING

    Milan, Italy

  • ICANS - Institut de cancérologie Strasbourg Europe

    RECRUITING

    Strasbourg, Bas-Rhin, France

  • IRCCS - lstituto Nazionale Tumori - Fondazione G. Pascale

    RECRUITING

    Naples, 80131, Italy

  • Institut Bergonie

    RECRUITING

    Bordeaux, Gironde, France

  • Institut Claudius Regaud

    RECRUITING

    Toulouse, Haute-Garonne, France

  • Institut Gustave Roussy

    RECRUITING

    Villejuif, Val-de-Marne, France

  • Institute Cancer De Lorraine

    RECRUITING

    Vandœuvre-lès-Nancy, 54519, France

  • Instituto de Investigacion Oncologica Vall d'Hebron (VHIO) - EPON

    RECRUITING

    Barcelona, Spain

  • Istituti Fisioterapici Ospitalieri - Istituto Nazionale Tumori Regina Elena

    RECRUITING

    Rome, Lazio, Italy

  • Istituto Clinico Humanitas

    RECRUITING

    Rozzano, Lombardy, Italy

  • Istituto Europeo Di Oncologia

    RECRUITING

    Milan, Lombardy, Italy

  • Karmanos Cancer Institute

    RECRUITING

    Detroit, Michigan, 48201, United States

  • Linear Clinical Research

    RECRUITING

    Nedlands, Western Australia, Australia

  • Massachusetts General Hospital

    RECRUITING

    Boston, Massachusetts, 02114, United States

  • Mater Cancer Care Centre

    RECRUITING

    South Brisbane, Queensland, Australia

  • Medical Oncology Hematology Consultants

    RECRUITING

    Newark, Delaware, 19713, United States

  • Medical University of South Carolina

    TERMINATED

    Charleston, South Carolina, 29425, United States

  • Memorial Sloan Kettering

    RECRUITING

    New York, New York, 10065, United States

  • Monash Medical Centre

    RECRUITING

    Clayton, Victoria, Australia

  • NEXT Oncology-Hospital Quironsalud Barcelona

    RECRUITING

    Barcelona, Spain

  • National Cancer Center

    RECRUITING

    Seoul, South Korea

  • National Cancer Center of Singapore

    RECRUITING

    Singapore, 168582, Singapore

  • National University Hospital

    RECRUITING

    Kent Ridge, Singapore

  • Nationale Centrum für Tumorerkrankungen (NCT) Heidelberg

    RECRUITING

    Heidelberg, Baden-Wurttemberg, Germany

  • New Experimental Therapeutics - NEXT Oncology

    RECRUITING

    Austin, Texas, 78705, United States

  • New Experimental Therapeutics of San Antonio - NEXT Oncology

    RECRUITING

    San Antonio, Texas, 78229, United States

  • Oregon Health & Science University (OHSU)

    RECRUITING

    Portland, Oregon, 97210, United States

  • Rocky Mountain Cancer Center

    RECRUITING

    Denver, Colorado, 80218, United States

  • START MADRID_Hospital Universitario Fundacion Jimenez Diaz

    RECRUITING

    Madrid, Madrid, Spain

  • START MADRID_Hospital Universitario HM Sanchinarro - CIOCC

    RECRUITING

    Madrid, Madrid, Spain

  • START Rioja

    RECRUITING

    Rioja, Spain

  • Samsung Medical Center

    RECRUITING

    Seoul, South Korea

  • Sarah Cannon Research Institute

    RECRUITING

    Nashville, Tennessee, 37203, United States

  • Sarah Cannon Research Institute UK

    RECRUITING

    London, Middlesex, United Kingdom

  • Seoul University Hospital

    RECRUITING

    Seoul, South Korea

  • Severance Hospital Yonsei University

    RECRUITING

    Seoul, South Korea

  • Texas Oncology

    RECRUITING

    Bedford, Texas, 76022, United States

  • The Cleveland Clinic Taussig Cancer Center

    RECRUITING

    Cleveland, Ohio, 44195, United States

  • The University of Texas MD Anderson Cancer Center

    RECRUITING

    Houston, Texas, 77030, United States

  • UCLA Jonsson Comprehensive Cancer Center

    RECRUITING

    Los Angeles, California, 90024, United States

  • USC Norris Comprehensive Cancer Center

    RECRUITING

    Los Angeles, California, 90033, United States

  • UT Southwest Simmons Cancer Center

    RECRUITING

    Dallas, Texas, 75390, United States

  • University of California Irvine Chao Family Comprehensive Cancer Center

    WITHDRAWN

    Irvine, California, 92868, United States

  • University of Miami - Sylvester Comprehensive Cancer Center

    RECRUITING

    Miami, Florida, 33136, United States

  • University of Nebraska Medical Center Buffet Cancer Center

    NOT_YET_RECRUITING

    Omaha, Nebraska, 68105, United States

  • University of Oklahoma

    RECRUITING

    Oklahoma City, Oklahoma, 73104, United States

  • University of Pittsburgh Medical Center

    RECRUITING

    Pittsburgh, Pennsylvania, 15213, United States

  • University of San Diego Moores Cancer Center

    RECRUITING

    La Jolla, California, 92093, United States

  • University of Washington, Fred Hutchinson Cancer Center

    RECRUITING

    Seattle, Washington, 98109, United States

  • University of Wisconsin Carbone Cancer Center

    RECRUITING

    Madison, Wisconsin, 53705, United States

  • Universitätsklinikum Augsburg

    RECRUITING

    Augsburg, Bavaria, Germany

  • Universitätsklinikum Essen

    RECRUITING

    Essen, North Rhine-Westphalia, Germany

  • Universitätsklinikum Frankfurt

    WITHDRAWN

    Frankfurt am Main, Hesse, Germany

  • Virginia Cancer Specialists

    RECRUITING

    Fairfax, Virginia, 22031, United States

  • WellSpan York Cancer Center

    RECRUITING

    York, Pennsylvania, 17403, United States

  • Yale Cancer Center

    RECRUITING

    New Haven, Connecticut, 06519, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.