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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04585750
Other study ID # PMV-586-101
Secondary ID KEYNOTE-D79MK-34
Status Recruiting
Phase Phase 1/Phase 2
First received
Last updated
Start date October 29, 2020
Est. completion date July 14, 2026

Study information

Verified date June 2024
Source PMV Pharmaceuticals, Inc
Contact PMV Pharma Clinical Study Information Center
Phone (609) 235-4038
Email clinicaltrials@pmvpharma.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

PC14586 (INN: rezatapopt) is a first-in-class, oral, small molecule p53 reactivator that is selective for the TP53 Y220C mutation. The primary objective of Phase 1 Monotherapy is to establish the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of PC14586 (INN: rezatapopt). Secondary objectives are to characterize the pharmacokinetic (PK) properties, safety and tolerability, and to assess preliminary efficacy including overall response rate (ORR). The primary objective of Phase 1b Combination Therapy is to establish the MTD/RP2D of PC14586 (INN: rezatapopt) when administered in combination with pembrolizumab. Secondary objectives of Phase 1b Combination Therapy are to characterize PK, safety and tolerability, and to assess preliminary efficacy of PC14586 (INN: rezatapopt) when administered in combination with pembrolizumab, including ORR. The primary objective of Phase 2 Monotherapy is to evaluate the efficacy of PC14586 (INN: rezatapopt) at the RP2D including the 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, PK properties, quality of life, and other efficacy measures of PC14586 (INN: rezatapopt) at the RP2D.


Recruitment information / eligibility

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)

Study Design


Intervention

Drug:
PC14586
First-in-class, oral, small molecule p53 reactivator selective for the p53 Y220C mutation.
pembrolizumab
Participants receive pembrolizumab 200 mg by intravenous (IV) infusion over 30 minutes.

Locations

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

Sponsors (2)

Lead Sponsor Collaborator
PMV Pharmaceuticals, Inc Merck Sharp & Dohme LLC

Countries where clinical trial is conducted

United States,  Australia,  France,  Germany,  Italy,  Korea, Republic of,  Singapore,  Spain,  United Kingdom, 

Outcome

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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