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P53 Y220C 変異を有する進行性固形腫瘍患者における PC14586 の評価

2026年10月1日 更新者：PMV Pharmaceuticals, Inc

P53 Y220C 変異を有する進行性固形腫瘍 (PYNNACLE) を有する患者における PC14586 の安全性、忍容性、薬物動態、薬力学、および有効性を評価するための第 1/2 相非盲検多施設試験

The Phase 2 monotherapy portion of this study is currently enrolling and will evaluate the efficacy and safety of PC14586 (INN rezatapopt) in participants with locally advanced or metastatic solid tumors harboring a TP53 Y220C mutation. The Phase 1 portion of the study will assess the safety, tolerability and preliminary efficacy of multiple dose levels of rezatapopt as monotherapy and in Phase 1b in combination with pembrolizumab.

調査の概要

状態

募集

条件

介入・治療

詳細な説明

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 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 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 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 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 rezatapopt when administered in combination with pembrolizumab, including ORR. Enrollment into Phase 1b Combination Therapy is complete.

研究の種類

介入

入学 (推定)

300

段階

  • フェーズ2
  • フェーズ 1

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究場所

  • アメリカ
    • California
      • Irvine、California、アメリカ、92868
        • 引きこもった
        • University of California Irvine Chao Family Comprehensive Cancer Center
      • La Jolla、California、アメリカ、92093
        • 募集
        • University of San Diego Moores Cancer Center
        • コンタクト：
          • Shumei Kato, MD
      • Los Angeles、California、アメリカ、90033
        • 募集
        • USC Norris Comprehensive Cancer Center
        • コンタクト：
          • Anthony El-Khoueiry, MD
      • Los Angeles、California、アメリカ、90024
        • 募集
        • UCLA Jonsson Comprehensive Cancer Center
        • コンタクト：
          • Gottfried Konecny, MD
    • Colorado
      • Denver、Colorado、アメリカ、80218
        • 募集
        • Rocky Mountain Cancer Center
        • コンタクト：
          • Allen Cohn, MD
    • Connecticut
      • New Haven、Connecticut、アメリカ、06519
        • 募集
        • Yale Cancer Center
        • コンタクト：
          • Patricia LoRusso, MD
    • Delaware
      • Newark、Delaware、アメリカ、19713
        • 募集
        • Medical Oncology Hematology Consultants
        • コンタクト：
          • Jamal Misleh, MD
    • Florida
      • Miami、Florida、アメリカ、33136
        • 募集
        • University of Miami - Sylvester Comprehensive Cancer Center
        • コンタクト：
          • Gilberto de Lima Lopes Jr., MD
      • Orlando、Florida、アメリカ、32803
        • 募集
        • Advent Health
        • コンタクト：
          • Robert Holloway, MD
      • Port Charlotte、Florida、アメリカ、33980
        • 募集
        • Florida Cancer Specialists South
        • コンタクト：
          • Ivor Percent, MD
    • Massachusetts
      • Boston、Massachusetts、アメリカ、02114
        • 募集
        • Massachusetts General Hospital
        • コンタクト：
          • Aparna Parikh, MD
      • Boston、Massachusetts、アメリカ、02215
        • 募集
        • Dana Farber Cancer Institute
        • コンタクト：
          • Geoffrey Shapiro, MD, PhD
    • Michigan
      • Detroit、Michigan、アメリカ、48201
        • 完了
        • Karmanos Cancer Institute
    • New York
      • New York、New York、アメリカ、10065
        • 募集
        • Memorial Sloan Kettering
        • コンタクト：
          • Alison Schram, MD
      • New York、New York、アメリカ、10032
        • まだ募集していません
        • Columbia University Medical Center
        • コンタクト：
          • June Hou, MD
    • North Carolina
      • Durham、North Carolina、アメリカ、27705
        • 募集
        • Duke University
        • コンタクト：
          • Niharika Mettu, MD, PhD
    • Ohio
      • Cleveland、Ohio、アメリカ、44195
        • 募集
        • The Cleveland Clinic Taussig Cancer Center
        • コンタクト：
          • Dale Shepard, MD
    • Oklahoma
      • Oklahoma City、Oklahoma、アメリカ、73104
        • 募集
        • University of Oklahoma
        • コンタクト：
          • Debra Richardson, MD
    • Oregon
      • Portland、Oregon、アメリカ、97210
        • 募集
        • Oregon Health & Science University (OHSU)
        • コンタクト：
          • Shivaani Kummar, MD
    • Pennsylvania
      • Philadelphia、Pennsylvania、アメリカ、19104
        • 募集
        • Abramson Cancer Center of the University of Pennsylvania
        • コンタクト：
          • Lainie Martin, MD
      • Pittsburgh、Pennsylvania、アメリカ、15213
        • 募集
        • University of Pittsburgh Medical Center
        • コンタクト：
          • Sarah Taylor, MD, PhD
      • York、Pennsylvania、アメリカ、17403
        • 募集
        • WellSpan York Cancer Center
        • コンタクト：
          • Ikechukwu Akunyili, MD
    • South Carolina
      • Charleston、South Carolina、アメリカ、29425
        • 終了しました
        • Medical University of South Carolina
    • Tennessee
      • Nashville、Tennessee、アメリカ、37203
        • 募集
        • Sarah Cannon Research Institute
        • コンタクト：
          • Melissa Johnson, MD
    • Texas
      • Austin、Texas、アメリカ、78705
        • 募集
        • New Experimental Therapeutics - NEXT Oncology
        • コンタクト：
          • David Sommerhalder, MD
      • Bedford、Texas、アメリカ、76022
        • 募集
        • Texas Oncology
        • コンタクト：
          • Terrence Wong, MD
      • Dallas、Texas、アメリカ、75390
        • 募集
        • UT Southwest Simmons Cancer Center
        • コンタクト：
          • David Miller, MD
      • Houston、Texas、アメリカ、77030
        • 募集
        • The University of Texas MD Anderson Cancer Center
        • コンタクト：
          • Ecaterina Dumbrava, MD
      • San Antonio、Texas、アメリカ、78229
        • 募集
        • New Experimental Therapeutics of San Antonio - NEXT Oncology
        • コンタクト：
          • David Sommerhalder, MD
    • Virginia
      • Fairfax、Virginia、アメリカ、22031
        • 募集
        • Virginia Cancer Specialists
        • コンタクト：
          • Alexander Spira, MD
    • Washington
      • Seattle、Washington、アメリカ、98109
        • 募集
        • University of Washington, Fred Hutchinson Cancer Center
        • コンタクト：
          • Andrew Coveler, MD
    • Wisconsin
      • Madison、Wisconsin、アメリカ、53705
        • 募集
        • University of Wisconsin Carbone Cancer Center
        • コンタクト：
          • Nataliya Uboha, MD, PhD
  • イギリス
    • Middlesex
      • London、Middlesex、イギリス
        • 募集
        • Sarah Cannon Research Institute UK
        • コンタクト：
          • Elisa Fontana, MD, PhD
    • Tyne and Wear
      • Newcastle upon Tyne、Tyne and Wear、イギリス
        • 募集
        • Freeman Hospital
        • コンタクト：
          • Alastair Greystoke, MB ChB PhD
  • イタリア
      • Milan、イタリア
        • 募集
        • Humanitas San Pio X
        • コンタクト：
          • Domenica Lorusso, MD
      • Naples、イタリア、80131
        • 募集
        • IRCCS - lstituto Nazionale Tumori - Fondazione G. Pascale
        • コンタクト：
          • Anna Passarelli, MD
    • Lazio
      • Rome、Lazio、イタリア
        • 募集
        • Fondazione Policlinico Universitario Agostino Gemelli IRCCS
        • コンタクト：
          • Anna Fagotti, MD
      • Rome、Lazio、イタリア
        • 募集
        • Istituti Fisioterapici Ospitalieri - Istituto Nazionale Tumori Regina Elena
        • コンタクト：
          • Lorenza Landi, MD
    • Lombardy
      • Milan、Lombardy、イタリア
        • 募集
        • ASST Grande Ospedale Metropolitano Niguarda
        • コンタクト：
          • Salvatore Siena, MD
      • Milan、Lombardy、イタリア
        • 募集
        • Fondazione IRCCS Istituto Nazionale Dei Tumori
        • コンタクト：
          • Massimo Di Nicola, MD
      • Milan、Lombardy、イタリア
        • 募集
        • Istituto Europeo Di Oncologia
        • コンタクト：
          • Giuseppe Curigliano, MD
      • Rozzano、Lombardy、イタリア
        • 募集
        • Istituto Clinico Humanitas
        • コンタクト：
          • Armando Santoro, MD
    • Torino
      • Candiolo、Torino、イタリア
        • 募集
        • Fondazione del Piemonte per l'Oncologia (IRCCS)
        • コンタクト：
          • Chiara Lazzari, MD
  • オーストラリア
    • New South Wales
      • Camperdown、New South Wales、オーストラリア
        • 募集
        • Chris O'Brien Lifehouse Hospital
        • コンタクト：
          • Peter Grimison, MD
    • Queensland
      • South Brisbane、Queensland、オーストラリア
        • 募集
        • Mater Cancer Care Centre
        • コンタクト：
          • Catherine Shannon, MD
    • South Australia
      • Bedford Park、South Australia、オーストラリア
        • 募集
        • Flinders Medical Center
        • コンタクト：
          • Shawgi Sukumaran, MD
    • Victoria
      • Clayton、Victoria、オーストラリア
        • 募集
        • Monash Medical Centre
        • コンタクト：
          • Sophia Frentzas, MD
    • Western Australia
      • Nedlands、Western Australia、オーストラリア
        • 募集
        • Linear Clinical Research
        • コンタクト：
          • Michael Millward, MD
  • シンガポール
      • Kent Ridge、シンガポール
        • 募集
        • National University Hospital
        • コンタクト：
          • David Shao Peng Tan, MD
      • Singapore、シンガポール、168582
        • 募集
        • National Cancer Center of Singapore
        • コンタクト：
          • Tira Tan, MD
  • スペイン
      • Barcelona、スペイン
        • 募集
        • NEXT Oncology-Hospital Quironsalud Barcelona
        • コンタクト：
          • Elena Garralda, MD
      • Barcelona、スペイン
        • 募集
        • Instituto de Investigacion Oncologica Vall d'Hebron (VHIO) - EPON
        • コンタクト：
          • Lorena Farinas, MD
      • Madrid、スペイン、28041
        • 募集
        • Hospital Universitario 12 de Octubre
        • コンタクト：
          • Santiago Ponce Aix, MD
      • Rioja、スペイン
        • 募集
        • START Rioja
        • コンタクト：
          • Jorge Luis Ramon Patino, MD
      • Valencia、スペイン
        • 募集
        • Hospital Clinico Universitario de Valencia
        • コンタクト：
          • José Alejandro Pérez Fidalgo, MD
    • Madrid
      • Madrid、Madrid、スペイン
        • 募集
        • START MADRID_Hospital Universitario Fundacion Jimenez Diaz
        • コンタクト：
          • Victor Moreno Garcia, MD
      • Madrid、Madrid、スペイン
        • 募集
        • START MADRID_Hospital Universitario HM Sanchinarro - CIOCC
        • コンタクト：
          • Irene Moreno, MD
  • ドイツ
    • Baden-Wurttemberg
      • Heidelberg、Baden-Wurttemberg、ドイツ
        • 募集
        • Nationale Centrum für Tumorerkrankungen (NCT) Heidelberg
        • コンタクト：
          • Martin Haag, MD
    • Bavaria
      • Augsburg、Bavaria、ドイツ
        • 募集
        • Universitätsklinikum Augsburg
        • コンタクト：
          • Rainer Claus, MD
    • Free and Hanseatic City of Hamburg
      • Hamburg、Free and Hanseatic City of Hamburg、ドイツ
        • 募集
        • Asklepios Klinik Altona
        • コンタクト：
          • Dirk Arnold, MD
    • Hesse
      • Frankfurt am Main、Hesse、ドイツ
        • 引きこもった
        • Universitätsklinikum Frankfurt
    • North Rhine-Westphalia
      • Essen、North Rhine-Westphalia、ドイツ
        • 募集
        • Universitätsklinikum Essen
        • コンタクト：
          • Marcel Wiesweg, MD
  • フランス
      • Lyon、フランス
        • 募集
        • Centre Léon Bérard Centre Régional de Lutte Contre Le Cancer
        • コンタクト：
          • Isabelle Ray-Coquard, MD
      • Nîmes、フランス、30900
        • 募集
        • CHU de Nîmes
        • コンタクト：
          • Frédéric Fiteni, MD, PhD
      • Vandœuvre-lès-Nancy、フランス、54519
        • 募集
        • Institute Cancer De Lorraine
        • コンタクト：
          • Aurélien Lambert, MD
    • Bas-Rhin
      • Strasbourg、Bas-Rhin、フランス
        • 募集
        • ICANS - Institut de cancérologie Strasbourg Europe
        • コンタクト：
          • Lauriane Eberst, MD
    • Gironde
      • Bordeaux、Gironde、フランス
        • 募集
        • Institut Bergonie
        • コンタクト：
          • Veronique Debien, MD
    • Haute-Garonne
      • Toulouse、Haute-Garonne、フランス
        • 募集
        • Institut Claudius Regaud
        • コンタクト：
          • Carlos-Alberto Gomez-Roca, MD
    • Loire-Atlantique
      • Saint-Herblain、Loire-Atlantique、フランス
        • 募集
        • EDOG Institut de Cancerologie de l'Ouest
        • コンタクト：
          • Jean-Sebastien Frenel, MD
    • Puy-de-Dôme
      • Clermont-Ferrand、Puy-de-Dôme、フランス
        • 募集
        • Centre Jean Perrin
        • コンタクト：
          • Xavier Durando, MD
    • Val-de-Marne
      • Villejuif、Val-de-Marne、フランス
        • 募集
        • Institut Gustave Roussy
        • コンタクト：
          • Yohann Loriot, MD
  • 韓国
      • Seoul、韓国
        • 募集
        • Samsung Medical Center
        • コンタクト：
          • Chel Hun Choi, MD
      • Seoul、韓国
        • 募集
        • Asan Medical Center
        • コンタクト：
          • Dae Ho Lee, MD
      • Seoul、韓国
        • 募集
        • Seoul University Hospital
        • コンタクト：
          • Seock-Ah Im, MD
      • Seoul、韓国
        • 募集
        • Severance Hospital Yonsei University
        • コンタクト：
          • Jung-Yun Lee, MD
      • Seoul、韓国
        • 募集
        • National Cancer Center
        • コンタクト：
          • Myong Cheol Lim, MD, PhD

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

12年歳以上 (子、大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

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). Exception: Ovarian cancer patients with a known KRAS SNV are permitted.

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：非ランダム化
  • 介入モデル：並列代入
  • マスキング：なし（オープンラベル）

武器と介入

参加者グループ / アーム
介入・治療
実験的：Phase 1 Monotherapy Dose Escalation

Multiple dose levels of daily oral 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 rezatapopt to recommend a Phase 2 dose (RP2D).
薬：rezatapopt

First-in-class, oral, small molecule p53 reactivator selective for the TP53 Y220C mutation.

他の名前：
  • PC14586
実験的：Phase 1b Combination Therapy Dose Escalation, Part 1

Multiple dose levels of daily oral 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 rezatapopt when administered in combination with pembrolizumab.
薬：rezatapopt

First-in-class, oral, small molecule p53 reactivator selective for the TP53 Y220C mutation.

他の名前：
  • PC14586
薬：pembrolizumab

Participants receive pembrolizumab 200 mg by intravenous (IV) infusion over 30 minutes.

他の名前：
  • MK-3475
  • キイトルーダ®
  • 基調講演-D79
  • MK-3475-D79
実験的：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.
薬：rezatapopt

First-in-class, oral, small molecule p53 reactivator selective for the TP53 Y220C mutation.

他の名前：
  • PC14586
薬：pembrolizumab

Participants receive pembrolizumab 200 mg by intravenous (IV) infusion over 30 minutes.

他の名前：
  • MK-3475
  • キイトルーダ®
  • 基調講演-D79
  • MK-3475-D79
実験的：Phase 1b Combination Therapy Dose Expansion, PD(L)-1 relapsed/refractory patients

Additional (expansion of) participants will enroll at the RP2D of daily oral 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.
薬：rezatapopt

First-in-class, oral, small molecule p53 reactivator selective for the TP53 Y220C mutation.

他の名前：
  • PC14586
薬：pembrolizumab

Participants receive pembrolizumab 200 mg by intravenous (IV) infusion over 30 minutes.

他の名前：
  • MK-3475
  • キイトルーダ®
  • 基調講演-D79
  • MK-3475-D79
実験的：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.
薬：rezatapopt

First-in-class, oral, small molecule p53 reactivator selective for the TP53 Y220C mutation.

他の名前：
  • PC14586
実験的：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.
薬：rezatapopt

First-in-class, oral, small molecule p53 reactivator selective for the TP53 Y220C mutation.

他の名前：
  • PC14586
実験的：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.
薬：rezatapopt

First-in-class, oral, small molecule p53 reactivator selective for the TP53 Y220C mutation.

他の名前：
  • PC14586
実験的：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.
薬：rezatapopt

First-in-class, oral, small molecule p53 reactivator selective for the TP53 Y220C mutation.

他の名前：
  • PC14586
実験的：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.
薬：rezatapopt

First-in-class, oral, small molecule p53 reactivator selective for the TP53 Y220C mutation.

他の名前：
  • PC14586

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Phase 1 Monotherapy (Dose Escalation): Determine the number and type of adverse events to characterize the safety of rezatapopt
時間枠：40 months

Number of participants with treatment related adverse events
40 months
Phase 1 Monotherapy (Dose Escalation): Establish the Recommended Phase 2 Dose (RP2D)
時間枠：30 months

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)
時間枠：The first 28 days of treatment (Cycle 1) per patient

Incidence of dose limiting toxicities (DLTs) during the first 28 days of treatment with 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 rezatapopt when administered in combination with pembrolizumab
時間枠：18 months for treatment arm

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 rezatapopt when administered in combination with pembrolizumab
時間枠：The first 28 days of combination treatment arm (starting on Day -7) per patient

Incidence of dose limiting toxicities (DLTs) during the first 28 days of treatment with 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 rezatapopt when administered in combination with pembrolizumab
時間枠：18 months

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 rezatapopt when administered in combination with pembrolizumab
時間枠：12 months for treatment arm

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 rezatapopt
時間枠：34 months

Overall response rate in accordance with Response Evaluation Criteria (RECIST) v.1.1 as assessed by independent review across all cohorts
34 months
Phase 2 Monotherapy (Dose Expansion): Response rate assessment to evaluate the clinical activity / efficacy of rezatapopt in ovarian cancer patients
時間枠：34 months

Overall response rate in accordance with Response Evaluation Criteria (RECIST) v.1.1 as assessed by independent review in the ovarian cancer cohort
34 months

二次結果の測定

結果測定
メジャーの説明
時間枠
Phase 1 Monotherapy: PK profile of rezatapopt - Peak concentration (Cmax)
時間枠：Approximately 12 months per patient (75 months for Phase 1 and Phase 2)

Pharmacokinetic parameters will be determined by non-compartmental methods using pharmacokinetic profile of rezatapopt
Approximately 12 months per patient (75 months for Phase 1 and Phase 2)
Phase 1 Monotherapy: PK profile of rezatapopt - Time of peak concentration (Tmax)
時間枠：Approximately 12 months per patient (75 months for Phase 1 and Phase 2)

Pharmacokinetic parameters will be determined by non-compartmental methods using pharmacokinetic profile of rezatapopt
Approximately 12 months per patient (75 months for Phase 1 and Phase 2)
Phase 1 Monotherapy: PK profile of rezatapopt - Area under the plasma concentration-time curve from time zero to time of last sampling timepoint (AUC0-t)
時間枠：Approximately 12 months per patient (75 months for Phase 1 and Phase 2)

Pharmacokinetic parameters will be determined by non-compartmental methods using pharmacokinetic profile of rezatapopt
Approximately 12 months per patient (75 months for Phase 1 and Phase 2)
Phase 1 Monotherapy: PK profile of rezatapopt - Area under the plasma concentration-time curve in one dosing interval (AUCtau)
時間枠：Approximately 12 months per patient (75 months for Phase 1 and Phase 2)

Pharmacokinetic parameters will be determined by non-compartmental methods using pharmacokinetic profile of rezatapopt
Approximately 12 months per patient (75 months for Phase 1 and Phase 2)
Phase 1 Monotherapy: PK profile of rezatapopt - Trough observed concentrations (Ctrough/Ctau)
時間枠：Approximately 12 months per patient (75 months for Phase 1 and Phase 2)

Pharmacokinetic parameters will be determined by non-compartmental methods using pharmacokinetic profile of 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 metabolites when rezatapopt is administered orally.
時間枠：Approximately 12 months per patient (75 months for Phase 1 and Phase 2)

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
時間枠：41 months for study (end of Phase 1)

Evaluation of preliminary anti-tumor activity of 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
時間枠：41 months for study (end of Phase 1)

Evaluation of preliminary anti-tumor activity of 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
時間枠：41 months for study (end of Phase 1)

Evaluation of preliminary anti-tumor activity of 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
時間枠：41 months for study (end of Phase 1)

Evaluation of preliminary anti-tumor activity of 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
時間枠：41 months for study (end of Phase 1)

Evaluation of preliminary anti-tumor activity of rezatapopt as a single agent
41 months for study (end of Phase 1)
Phase 1 Monotherapy (Dose Escalation): Overall Survival
時間枠：41 months for study (end of Phase 1)

Evaluation of preliminary anti-tumor activity of rezatapopt as a single agent
41 months for study (end of Phase 1)
Phase 1b Combination Therapy: PK profile of rezatapopt in combination with pembrolizumab - Peak concentration (Cmax)
時間枠：Approximately 12 months per patient (30 months for treatment arm)

Pharmacokinetic parameters will be determined by non-compartmental methods using pharmacokinetic profile of rezatapopt
Approximately 12 months per patient (30 months for treatment arm)
Phase 1b Combination Therapy: PK profile of rezatapopt in combination with pembrolizumab - Time of peak concentration (Tmax)
時間枠：Approximately 12 months per patient (30 months for treatment arm)

Pharmacokinetic parameters will be determined by non-compartmental methods using pharmacokinetic profile of rezatapopt
Approximately 12 months per patient (30 months for treatment arm)
Phase 1b Combination Therapy: PK profile of rezatapopt in combination with pembrolizumab - Area under the plasma concentration-time curve from time zero to time of last sampling timepoint (AUC0-t)
時間枠：Approximately 12 months per patient (30 months for treatment arm)

Pharmacokinetic parameters will be determined by non-compartmental methods using pharmacokinetic profile of rezatapopt
Approximately 12 months per patient (30 months for treatment arm)
Phase 1b Combination Therapy: PK profile of rezatapopt in combination with pembrolizumab - Area under the plasma concentration-time curve in one dosing interval (AUCtau)
時間枠：Approximately 12 months per patient (30 months for treatment arm)

Pharmacokinetic parameters will be determined by non-compartmental methods using pharmacokinetic profile of rezatapopt
Approximately 12 months per patient (30 months for treatment arm)
Phase 1b Combination Therapy: PK profile of rezatapopt in combination with pembrolizumab - Trough observed concentrations (Ctrough/Ctau)
時間枠：Approximately 12 months per patient (30 months for treatment arm)

Pharmacokinetic parameters will be determined by non-compartmental methods using pharmacokinetic profile of rezatapopt
Approximately 12 months per patient (30 months for treatment arm)
Phase 1b Combination Therapy: Blood plasma assessment to describe the concentration of rezatapopt and metabolites when rezatapopt is administered orally in combination with pembrolizumab.
時間枠：Approximately 12 months per patient (30 months for treatment arm)

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
時間枠：30 months for study (end of Phase 1b)

Evaluation of anti-tumor activity of 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
時間枠：30 months for study (end of Phase 1b)

Evaluation of anti-tumor activity of 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
時間枠：30 months for study (end of Phase 1b)

Evaluation of anti-tumor activity of 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
時間枠：30 months for study (end of Phase 1b)

Evaluation of anti-tumor activity of rezatapopt in combination with pembrolizumab
30 months for study (end of Phase 1b)
Phase 1b Combination Therapy: Overall Survival
時間枠：30 months for study (end of Phase 1b)

Evaluation of anti-tumor activity of 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 rezatapopt
時間枠：30 months for study (end of Phase 1b)

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
時間枠：30 months for study (end of Phase 1b)

Evaluation of anti-tumor activity of rezatapopt in combination with pembrolizumab
30 months for study (end of Phase 1b)
Phase 2 Monotherapy: PK profile of rezatapopt - Time of peak concentration (Tmax)
時間枠：Approximately 12 months per patient (75 months for Phase 1 and Phase 2)

Pharmacokinetic parameters will be determined by non-compartmental methods using pharmacokinetic profile of rezatapopt
Approximately 12 months per patient (75 months for Phase 1 and Phase 2)
Phase 2 Monotherapy: PK profile of rezatapopt - Peak concentration (Cmax)
時間枠：Approximately 12 months per patient (75 months for Phase 1 and Phase 2)

Pharmacokinetic parameters will be determined by non-compartmental methods using pharmacokinetic profile of rezatapopt
Approximately 12 months per patient (75 months for Phase 1 and Phase 2)
Phase 2 Monotherapy: PK profile of rezatapopt - Area under the plasma concentration-time curve from time zero to time of last sampling timepoint (AUC0-t)
時間枠：Approximately 12 months per patient (75 months for Phase 1 and Phase 2)

Pharmacokinetic parameters will be determined by non-compartmental methods using pharmacokinetic profile of rezatapopt
Approximately 12 months per patient (75 months for Phase 1 and Phase 2)
Phase 2 Monotherapy: PK profile of rezatapopt - Area under the plasma concentration-time curve in one dosing interval (AUCtau)
時間枠：Approximately 12 months per patient (75 months for Phase 1 and Phase 2)

Pharmacokinetic parameters will be determined by non-compartmental methods using pharmacokinetic profile of rezatapopt
Approximately 12 months per patient (75 months for Phase 1 and Phase 2)
Phase 2 Monotherapy: PK profile of rezatapopt - Trough observed concentrations (Ctrough/Ctau)
時間枠：Approximately 12 months per patient (75 months for Phase 1 and Phase 2)

Pharmacokinetic parameters will be determined by non-compartmental methods using pharmacokinetic profile of 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 rezatapopt and metabolites when rezatapopt is administered orally.
時間枠：Approximately 12 months per patient (75 months for Phase 1 and Phase 2)

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 rezatapopt
時間枠：34 months for study (end of Phase 2)

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
時間枠：34 months for study (end of Phase 2)

Evaluation of anti-tumor activity of 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
時間枠：34 months for study (end of Phase 2)

Evaluation of anti-tumor activity of 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
時間枠：34 months for study (end of Phase 2)

Evaluation of anti-tumor activity of 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
時間枠：34 months for study (end of Phase 2)

Evaluation of anti-tumor activity of 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
時間枠：34 months for study (end of Phase 2)

Evaluation of anti-tumor activity of 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
時間枠：34 months for study (end of Phase 2)

Evaluation of anti-tumor activity of 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
時間枠：34 months for study (end of Phase 2)

Evaluation of anti-tumor activity of 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
時間枠：34 months for study (end of Phase 2)

Evaluation of anti-tumor activity of 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
時間枠：34 months for study (end of Phase 2)

Evaluation of anti-tumor activity of 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
時間枠：34 months for study (end of Phase 2)

Evaluation of anti-tumor activity of rezatapopt as a single agent
34 months for study (end of Phase 2)
Phase 2 Monotherapy (Dose Expansion): Overall Survival in ovarian cancer cohort
時間枠：34 months for study (end of Phase 2)

Evaluation of anti-tumor activity of rezatapopt as a single agent
34 months for study (end of Phase 2)
Phase 2 Monotherapy (Dose Expansion): Overall Survival across all cohorts
時間枠：34 months for study (end of Phase 2)

Evaluation of anti-tumor activity of rezatapopt as a single agent
34 months for study (end of Phase 2)
Phase 2 Monotherapy (Dose Expansion): Quality of life assessment
時間枠：Evaluated at every visit. 34 months for treatment arm (end of Phase 2)

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)

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

PMV Pharmaceuticals, Inc

協力者

Merck Sharp & Dohme LLC

捜査官

  • スタディディレクター：Marc Fellous, MD、Sr. Vice President, Clinical Development and Medical Affairs

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2020年10月29日

一次修了 (推定)

2026年12月15日

研究の完了 (推定)

2027年12月31日

試験登録日

最初に提出

2020年10月1日

QC基準を満たした最初の提出物

2020年10月7日

最初の投稿 (実際)

2020年10月14日

学習記録の更新

投稿された最後の更新 (実際)

2026年10月2日

QC基準を満たした最後の更新が送信されました

2026年10月1日

最終確認日

2026年10月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • PMV-586-101
  • KEYNOTE-D79 (レジストリ識別子：Merck, Sharp & Dohme, LLC)
  • MK-3475-D79 (レジストリ識別子：Merck, Sharp & Dohme, LLC)

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

はい

米国FDA規制機器製品の研究

いいえ

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