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| ID | Type | Description | Link |
|---|---|---|---|
| KEYNOTE-D79 | Registry Identifier | Merck, Sharp & Dohme, LLC | |
| MK-3475-D79 | Registry Identifier | Merck, Sharp & Dohme, LLC |
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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase 1 Monotherapy Dose Escalation | Experimental | 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). |
|
| Phase 1b Combination Therapy Dose Escalation, Part 1 | Experimental | 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. |
|
| Phase 1b Combination Therapy Dose Expansion, PD(L)-1 naive patients | Experimental | 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. |
|
| Phase 1b Combination Therapy Dose Expansion, PD(L)-1 relapsed/refractory patients | Experimental | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rezatapopt | Drug | First-in-class, oral, small molecule p53 reactivator selective for the TP53 Y220C mutation. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Phase 1 Monotherapy (Dose Escalation): Determine the number and type of adverse events to characterize the safety of rezatapopt | Number of participants with treatment related adverse events | 40 months |
| 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 |
| 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 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 | 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 | 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 | RP2D will be determined using available safety and pharmacokinetics and pharmacodynamics data |
| Measure | Description | Time Frame |
|---|---|---|
| Phase 1 Monotherapy: PK profile of rezatapopt - Peak concentration (Cmax) | 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) |
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Inclusion Criteria:
Additional Criteria for Inclusion in Phase 1b (rezatapopt) + pembrolizumab combination)
Exclusion Criteria:
Additional Criteria for Exclusion from Phase 2 (rezatapopt monotherapy)
Additional Criteria for Exclusion from Phase 1b (rezatapopt) + pembrolizumab combination)
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| PMV Pharma Clinical Study Information Center | Contact | (609) 235-4038 | clinicaltrials@pmvpharma.com |
| Name | Affiliation | Role |
|---|---|---|
| Marc Fellous, MD | Sr. Vice President of Medical Affairs | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California Irvine Chao Family Comprehensive Cancer Center | Withdrawn | Irvine | California | 92868 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41740031 | Derived | Dumbrava EE, Shapiro GI, Parikh AR, Johnson ML, Tolcher AW, Thompson JA, El-Khoueiry AB, Vandross AL, Kummar S, Shepard DR, LeDuke K, Sheehan L, Alland L, Haque A, Jalota D, Fellous M, Schram AM. Phase 1 Study of Rezatapopt, a p53 Reactivator, in TP53 Y220C-Mutated Tumors. N Engl J Med. 2026 Feb 26;394(9):872-883. doi: 10.1056/NEJMoa2508820. | |
| 40932470 |
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During Phase 2 Monotherapy, 2000mg QD of PC14586 (INN: rezatapopt) will be assigned to all participants. Participants will be assigned to one of five cohorts: ovarian cancer, lung cancer, breast cancer, endometrial cancer, or other solid tumors. Enrollment ongoing.
During Phase 1 Monotherapy (Dose Escalation), participants will be assigned a dose level using an accelerated titration design in the initial dose cohorts, followed by a modified toxicity probability interval (mTPI) design in subsequent dose cohorts. Enrollment closed.
During Part 1 of the Ph 1b Combination Therapy, patients will be assigned a dose level using mTPI design. A recommended rezatapopt Phase 2 Dose (RP2D) when administered in combination with pembrolizumab will be selected at the end of Phase 1b Part 1, and the RP2D will be assigned to all participants in Part 2. Enrollment closed.
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|
| Phase 2 Monotherapy Dose Expansion, Ovarian Cancer Cohort | Experimental | 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. |
|
| Phase 2 Monotherapy Dose Expansion, Lung Cancer Cohort | Experimental | 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. |
|
| Phase 2 Monotherapy Dose Expansion, Breast Cancer Cohort | Experimental | 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. |
|
| Phase 2 Monotherapy Dose Expansion, Endometrial Cancer Cohort | Experimental | 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. |
|
| Phase 2 Monotherapy Dose Expansion, Other Solid Tumors Cohort | Experimental | 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. |
|
|
| pembrolizumab | Drug | Participants receive pembrolizumab 200 mg by intravenous (IV) infusion over 30 minutes. |
|
|
| 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 | 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 | 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 | 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 |
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) | 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) | 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) | 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. | 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 | 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 | 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 | 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 | 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 | 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 | 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) | 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) | 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) | 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) | 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) | 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. | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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) | 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) | 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) | 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) | 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) | 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. | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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) |
| University of San Diego Moores Cancer Center | Not yet recruiting | La Jolla | California | 92093 | United States |
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| UCLA Jonsson Comprehensive Cancer Center | Recruiting | Los Angeles | California | 90024 | United States |
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| USC Norris Comprehensive Cancer Center | Recruiting | Los Angeles | California | 90033 | United States |
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| Rocky Mountain Cancer Center | Recruiting | Denver | Colorado | 80218 | United States |
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| Yale Cancer Center | Recruiting | New Haven | Connecticut | 06519 | United States |
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| Medical Oncology Hematology Consultants | Recruiting | Newark | Delaware | 19713 | United States |
|
| University of Miami - Sylvester Comprehensive Cancer Center | Recruiting | Miami | Florida | 33136 | United States |
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| Advent Health | Recruiting | Orlando | Florida | 32803 | United States |
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| Florida Cancer Specialists South | Recruiting | Port Charlotte | Florida | 33980 | United States |
|
| Massachusetts General Hospital | Recruiting | Boston | Massachusetts | 02114 | United States |
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| Dana Farber Cancer Institute | Recruiting | Boston | Massachusetts | 02215 | United States |
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| Karmanos Cancer Institute | Recruiting | Detroit | Michigan | 48201 | United States |
|
| University of Nebraska Medical Center Buffet Cancer Center | Not yet recruiting | Omaha | Nebraska | 68105 | United States |
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| Memorial Sloan Kettering | Recruiting | New York | New York | 10065 | United States |
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| Duke University | Recruiting | Durham | North Carolina | 27705 | United States |
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| The Cleveland Clinic Taussig Cancer Center | Recruiting | Cleveland | Ohio | 44195 | United States |
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| University of Oklahoma | Recruiting | Oklahoma City | Oklahoma | 73104 | United States |
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| Oregon Health & Science University (OHSU) | Recruiting | Portland | Oregon | 97210 | United States |
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| Abramson Cancer Center of the University of Pennsylvania | Recruiting | Philadelphia | Pennsylvania | 19104 | United States |
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| University of Pittsburgh Medical Center | Recruiting | Pittsburgh | Pennsylvania | 15213 | United States |
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| WellSpan York Cancer Center | Recruiting | York | Pennsylvania | 17403 | United States |
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| Medical University of South Carolina | Terminated | Charleston | South Carolina | 29425 | United States |
| Sarah Cannon Research Institute | Recruiting | Nashville | Tennessee | 37203 | United States |
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| New Experimental Therapeutics - NEXT Oncology | Recruiting | Austin | Texas | 78705 | United States |
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| Texas Oncology | Recruiting | Bedford | Texas | 76022 | United States |
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| UTSW - Moody Outpatient Center - Parkland Health | Not yet recruiting | Dallas | Texas | 75235 | United States |
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| UT Southwest Simmons Cancer Center | Recruiting | Dallas | Texas | 75390 | United States |
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| The University of Texas MD Anderson Cancer Center | Recruiting | Houston | Texas | 77030 | United States |
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| New Experimental Therapeutics of San Antonio - NEXT Oncology | Recruiting | San Antonio | Texas | 78229 | United States |
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| Virginia Cancer Specialists | Recruiting | Fairfax | Virginia | 22031 | United States |
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| University of Washington, Fred Hutchinson Cancer Center | Recruiting | Seattle | Washington | 98109 | United States |
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| University of Wisconsin Carbone Cancer Center | Recruiting | Madison | Wisconsin | 53705 | United States |
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| Chris O'Brien Lifehouse Hospital | Recruiting | Camperdown | New South Wales | Australia |
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| Mater Cancer Care Centre | Recruiting | South Brisbane | Queensland | Australia |
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| Flinders Medical Center | Recruiting | Bedford Park | South Australia | Australia |
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| Monash Medical Centre | Recruiting | Clayton | Victoria | Australia |
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| Linear Clinical Research | Recruiting | Nedlands | Western Australia | Australia |
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| ICANS - Institut de cancérologie Strasbourg Europe | Recruiting | Strasbourg | Bas-Rhin | France |
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| Institut Bergonie | Recruiting | Bordeaux | Gironde | France |
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| Institut Claudius Regaud | Recruiting | Toulouse | Haute-Garonne | France |
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| EDOG Institut de Cancerologie de l'Ouest | Recruiting | Saint-Herblain | Loire-Atlantique | France |
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| Centre Jean Perrin | Recruiting | Clermont-Ferrand | Puy-de-Dôme | France |
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| Institut Gustave Roussy | Recruiting | Villejuif | Val-de-Marne | France |
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| Centre Léon Bérard Centre Régional de Lutte Contre Le Cancer | Recruiting | Lyon | France |
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| CHU de Nîmes | Recruiting | Nîmes | 30900 | France |
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| Institute Cancer De Lorraine | Recruiting | Vandœuvre-lès-Nancy | 54519 | France |
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| Nationale Centrum für Tumorerkrankungen (NCT) Heidelberg | Recruiting | Heidelberg | Baden-Wurttemberg | Germany |
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| Universitätsklinikum Augsburg | Recruiting | Augsburg | Bavaria | Germany |
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| Asklepios Klinik Altona | Recruiting | Hamburg | Free and Hanseatic City of Hamburg | Germany |
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| Universitätsklinikum Frankfurt | Withdrawn | Frankfurt am Main | Hesse | Germany |
| Universitätsklinikum Essen | Recruiting | Essen | North Rhine-Westphalia | Germany |
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| Fondazione Policlinico Universitario Agostino Gemelli IRCCS | Recruiting | Rome | Lazio | Italy |
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| Istituti Fisioterapici Ospitalieri - Istituto Nazionale Tumori Regina Elena | Recruiting | Rome | Lazio | Italy |
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| ASST Grande Ospedale Metropolitano Niguarda | Recruiting | Milan | Lombardy | Italy |
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| Fondazione IRCCS Istituto Nazionale Dei Tumori | Recruiting | Milan | Lombardy | Italy |
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| Istituto Europeo Di Oncologia | Recruiting | Milan | Lombardy | Italy |
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| Istituto Clinico Humanitas | Recruiting | Rozzano | Lombardy | Italy |
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| Fondazione del Piemonte per l'Oncologia (IRCCS) | Recruiting | Candiolo | Torino | Italy |
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| Humanitas San Pio X | Recruiting | Milan | Italy |
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| IRCCS - lstituto Nazionale Tumori - Fondazione G. Pascale | Recruiting | Naples | 80131 | Italy |
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| National University Hospital | Recruiting | Kent Ridge | Singapore |
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| National Cancer Center of Singapore | Recruiting | Singapore | 168582 | Singapore |
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| Asan Medical Center | Recruiting | Seoul | South Korea |
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| National Cancer Center | Recruiting | Seoul | South Korea |
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| Samsung Medical Center | Recruiting | Seoul | South Korea |
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| Seoul University Hospital | Recruiting | Seoul | South Korea |
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| Severance Hospital Yonsei University | Recruiting | Seoul | South Korea |
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| START MADRID_Hospital Universitario Fundacion Jimenez Diaz | Recruiting | Madrid | Madrid | Spain |
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| START MADRID_Hospital Universitario HM Sanchinarro - CIOCC | Recruiting | Madrid | Madrid | Spain |
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| Instituto de Investigacion Oncologica Vall d'Hebron (VHIO) - EPON | Recruiting | Barcelona | Spain |
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| NEXT Oncology-Hospital Quironsalud Barcelona | Recruiting | Barcelona | Spain |
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| Hospital Universitario 12 de Octubre | Recruiting | Madrid | 28041 | Spain |
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| START Rioja | Recruiting | Rioja | Spain |
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| Hospital Clinico Universitario de Valencia | Recruiting | Valencia | Spain |
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| Sarah Cannon Research Institute UK | Recruiting | London | Middlesex | United Kingdom |
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| Freeman Hospital | Recruiting | Newcastle upon Tyne | Tyne and Wear | United Kingdom |
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| Schram AM, Fellous M, LeDuke K, Schmid A, Dumbrava EE. PYNNACLE phase II clinical trial protocol: rezatapopt (PC14586) monotherapy in advanced or metastatic solid tumors with a TP53 Y220C mutation. Future Oncol. 2025 Oct;21(24):3159-3166. doi: 10.1080/14796694.2025.2557176. Epub 2025 Sep 11. |
| 40543428 | Derived | Papavassiliou KA, Vassiliou AG, Papavassiliou AG. Rezatapopt: A promising small-molecule "refolder" specific for TP53Y220C mutant tumors. Neoplasia. 2025 Sep;67:101201. doi: 10.1016/j.neo.2025.101201. Epub 2025 Jun 20. |
| ID | Term |
|---|---|
| D009362 | Neoplasm Metastasis |
| D008175 | Lung Neoplasms |
| D010051 | Ovarian Neoplasms |
| D016889 | Endometrial Neoplasms |
| D011471 | Prostatic Neoplasms |
| D015179 | Colorectal Neoplasms |
| D001943 | Breast Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D005706 | Gallbladder Neoplasms |
| D055752 | Small Cell Lung Carcinoma |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D064726 | Triple Negative Breast Neoplasms |
| ID | Term |
|---|---|
| D009385 | Neoplastic Processes |
| D009369 | Neoplasms |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D014594 | Uterine Neoplasms |
| D014591 | Uterine Diseases |
| D005834 | Genital Neoplasms, Male |
| D005832 | Genital Diseases, Male |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001661 | Biliary Tract Neoplasms |
| D001660 | Biliary Tract Diseases |
| D005705 | Gallbladder Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| C582435 | pembrolizumab |
Not provided
Not provided
Not provided