Breast Cancer Clinical Trial
Official title:
A Phase 1/2 Open-label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of PC14586 in Patients With Locally Advanced or Metastatic Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE)
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.
Status | Recruiting |
Enrollment | 230 |
Est. completion date | July 14, 2026 |
Est. primary completion date | March 17, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 12 Years and older |
Eligibility | Inclusion Criteria: - At least 18 years of age or 12 to 17 years of age after Safety Review Committee approval. - Advanced solid malignancy with a TP53 Y220C mutation - Eastern Cooperative Oncology Group (ECOG) status of 0 or 1 - Previously treated with one or more lines of anticancer therapy and progressive disease - Adequate organ function - Measurable disease per RECIST v1.1 (Phase 2) Additional Criteria for Inclusion in Phase 1b (PC14586 (INN: rezatapopt) + pembrolizumab combination) - Anti-PD-1/PD-L1 naive or must have progressed on treatment - Measurable disease Exclusion Criteria: - Anti-cancer therapy within 21 days (or 5 half-lives) of receiving the study drug - Radiotherapy within 28 days of receiving the study drug - Primary CNS tumor - History of leptomeningeal disease or spinal cord compression - Brain metastases, unless neurologically stable and do not require steroids to treat associated neurological symptoms - Stroke or transient ischemic attack within 6 months prior to screening - Heart conditions such as unstable angina, uncontrolled hypertension, a heart attack within 6 months prior to screening, congestive heart failure, prolongation of QT interval, or other rhythm abnormalities - Strong CYP3A4 inhibitors or inducers, medications with a known risk of QT/QTc prolongation, or proton pump inhibitors - History of gastrointestinal (GI) disease that may interfere with absorption of study drug or patients unable to take oral medication - History of prior organ transplant - Known, active malignancy, except for treated cervical intraepithelial neoplasia, or non-melanoma skin cancer - Known, active uncontrolled Hepatitis B, Hepatitis C, or human immunodeficiency virus infection Additional Criteria for Exclusion from Phase 2 (PC14586 monotherapy) - Known KRAS mutation, defined as a single nucleotide variant (SNV) (Phase 2) Additional Criteria for Exclusion from Phase 1b (PC14586 (INN: rezatapopt) + pembrolizumab combination) - Received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor and discontinued from that treatment due to a Grade 3 or higher immune-related AE (irAE) - Received a live or live-attenuated vaccine within 30 days prior to the first dose of study intervention - Diagnosis of immunodeficiency or receiving chronic systemic steroid therapy within 7 days prior to the first dose of study drug - Hypersensitivity (= Grade 3) to pembrolizumab and/or any of its excipients - Active autoimmune disease that has required systemic treatment in past 2 years - History of radiation pneumonitis - History of (non-infectious) or active pneumonitis / interstitial lung disease that required steroids - Active infection requiring systemic therapy - Known history of HIV infection - Has previously received PC14586 (INN: rezatapopt) |
Country | Name | City | State |
---|---|---|---|
Australia | Chris O'Brien Lifehouse Hospital | Camperdown | New South Wales |
Australia | Monash Medical Centre | Clayton | Victoria |
Australia | Linear Clinical Research | Nedlands | Western Australia |
France | Institut Bergonie | Bordeaux | Gironde |
France | Centre Jean Perrin | Clermont-Ferrand | Puy-de-Dôme |
France | Centre Léon Bérard Centre Régional de Lutte Contre Le Cancer | Lyon | |
France | EDOG Institut de Cancerologie de l'Ouest | Saint-Herblain | Loire-Atlantique |
France | ICANS - Institut de cancérologie Strasbourg Europe | Strasbourg | Bas-Rhin |
France | Institut Claudius Regaud | Toulouse | Haute-Garonne |
France | Institut Gustave Roussy | Villejuif | Val-de-Marne |
Germany | Universitätsklinikum Augsburg | Augsburg | Bayern |
Germany | Universitätsklinikum Essen | Essen | Nordrhein-Westfalen |
Germany | Universitätsklinikum Frankfurt | Frankfurt | Hessen |
Germany | Asklepios Klinik Altona | Hamburg | |
Germany | Nationale Centrum für Tumorerkrankungen (NCT) Heidelberg | Heidelberg | Baden-Württemberg |
Italy | Fondazione del Piemonte per l'Oncologia (IRCCS) | Candiolo | Torino |
Italy | ASST Grande Ospedale Metropolitano Niguarda | Milano | Lombardia |
Italy | Fondazione IRCCS Istituto Nazionale Dei Tumori | Milano | Lombardia |
Italy | Istituto Europeo Di Oncologia | Milano | Lombardia |
Italy | Fondazione Policlinico Universitario Agostino Gemelli IRCCS | Rome | Lazio |
Italy | Istituti Fisioterapici Ospitalieri - Istituto Nazionale Tumori Regina Elena | Rome | Lazio |
Italy | Istituto Clinico Humanitas | Rozzano | Lombardia |
Korea, Republic of | Asan Medical Center | Seoul | |
Korea, Republic of | Seoul University Hospital | Seoul | |
Singapore | National University Hospital | Kent Ridge | |
Singapore | National Cancer Center of Singapore | Singapore | |
Spain | Instituto de Investigacion Oncologica Vall d'Hebron (VHIO) - EPON | Barcelona | |
Spain | NEXT Oncology-Hospital Quironsalud Barcelona | Barcelona | |
Spain | START MADRID_Hospital Universitario Fundacion Jimenez Diaz | Madrid | |
Spain | START MADRID_Hospital Universitario HM Sanchinarro - CIOCC | Madrid | |
Spain | Hospital Clinico Universitario de Valencia | Valencia | |
United Kingdom | Sarah Cannon Research Institute UK | London | Middlesex |
United Kingdom | Royal Victoria Infirmary | Newcastle Upon Tyne | Tyne And Wear |
United States | New Experimental Therapeutics - NEXT Oncology | Austin | Texas |
United States | Dana Farber Cancer Institute | Boston | Massachusetts |
United States | Massachusetts General Hospital | Boston | Massachusetts |
United States | Roswell Park Comprehensive Cancer Institute | Buffalo | New York |
United States | Medical University of South Carolina | Charleston | South Carolina |
United States | The Cleveland Clinic Taussig Cancer Center | Cleveland | Ohio |
United States | Rocky Mountain Cancer Center | Denver | Colorado |
United States | Karmanos Cancer Institute | Detroit | Michigan |
United States | Duke University | Durham | North Carolina |
United States | Virginia Cancer Specialists | Fairfax | Virginia |
United States | The University of Texas MD Anderson Cancer Center | Houston | Texas |
United States | Indiana University | Indianapolis | Indiana |
United States | USC Norris Comprehensive Cancer Center | Los Angeles | California |
United States | University of Wisconsin Carbone Cancer Center | Madison | Wisconsin |
United States | University of Miami - Sylvester Comprehensive Cancer Center | Miami | Florida |
United States | Sarah Cannon Research Institute | Nashville | Tennessee |
United States | Yale Cancer Center | New Haven | Connecticut |
United States | Memorial Sloan Kettering | New York | New York |
United States | University of Oklahoma | Oklahoma City | Oklahoma |
United States | Abramson Cancer Center of the University of Pennsylvania | Philadelphia | Pennsylvania |
United States | Oregon Health & Science University (OHSU) | Portland | Oregon |
United States | New Experimental Therapeutics of San Antonio - NEXT Oncology | San Antonio | Texas |
United States | University of Washington, Fred Hutchinson Cancer Center | Seattle | Washington |
United States | Florida Cancer Specialists South | West Palm Beach | Florida |
Lead Sponsor | Collaborator |
---|---|
PMV Pharmaceuticals, Inc | Merck Sharp & Dohme LLC |
United States, Australia, France, Germany, Italy, Korea, Republic of, Singapore, Spain, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | 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) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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) |
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