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JOURNAL ONKOLOGIE – STUDIE

The Evaluation of PC14586 in Patients With Advanced Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE)

Rekrutierend

NCT-Nummer:
NCT04585750

Studienbeginn:
Oktober 2020

Letztes Update:
09.02.2024

Wirkstoff:
PC14586, Pembrolizumab

Indikation (Clinical Trials):
Neoplasms, Endometrial Neoplasms

Geschlecht:
Alle

Altersgruppe:
Alle

Phase:
-

Sponsor:
PMV Pharmaceuticals, Inc

Collaborator:
Merck Sharp & Dohme LLC

Studienleiter

Marc Fellous, MD
Study Director
Vice President of Medical Affairs

Kontakt

PMV Pharma Clinical Study Information Center
Kontakt:
Phone: (609) 235-4038
E-Mail: clinicaltrials@pmvpharma.com» Kontaktdaten anzeigen

Studienlocations
(3 von 55)

Alle anzeigen

Studien-Informationen

Detailed 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.

Ein-/Ausschlusskriterien

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)

Studien-Rationale

Primary outcome:

1. Phase 1 Monotherapy (Dose Escalation): Determine the number and type of adverse events to characterize the safety of PC14586 (INN: rezatapopt) (Time Frame - 40 months):
Number of participants with treatment related adverse events

2. Phase 1 Monotherapy (Dose Escalation): Establish the Recommended Phase 2 Dose (RP2D) (Time Frame - 30 months):
RP2D will be determined using available safety and pharmacokinetics and pharmacodynamics data

3. Phase 1 Monotherapy (Dose Escalation): Establish the maximum tolerated dose (MTD) (Phase 1) (Time Frame - The first 28 days of treatment (Cycle 1) per patient):
Incidence of dose limiting toxicities (DLTs) during the first 28 days of treatment with PC14586 (INN: rezatapopt)

4. 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 (Time Frame - 18 months for treatment arm):
Number of participants with treatment related adverse events

5. Phase 1b Combination Therapy (Part 1: Dose Escalation): Establish the maximum tolerated dose (MTD) of PC14586 (INN: rezatapopt) when administered in combination with pembrolizumab (Time Frame - 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 PC14586 (INN: rezatapopt)

6. 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 (Time Frame - 18 months):
RP2D will be determined using available safety and pharmacokinetics and pharmacodynamics data

7. 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 (Time Frame - 12 months for treatment arm):
Number of participants with treatment related adverse events

8. Phase 2 Monotherapy (Dose Expansion): Response rate assessment to evaluate the clinical activity / efficacy of PC14586 (INN: rezatapopt) (Time Frame - 34 months):
Overall response rate in accordance with Response Evaluation Criteria across all cohorts (RECIST) v.1.1 as assessed by independent review

Secondary outcome:

1. Phase 1 Monotherapy: PK profile of PC14586 (INN: rezatapopt) - Peak concentration (Cmax) (Time Frame - 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 PC14586 (INN: rezatapopt)

2. Phase 1 Monotherapy: PK profile of PC14586 (INN: rezatapopt) - Time of peak concentration (Tmax) (Time Frame - 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 PC14586 (INN: rezatapopt)

3. 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) (Time Frame - 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 PC14586 (INN: rezatapopt)

4. Phase 1 Monotherapy: PK profile of PC14586 (INN: rezatapopt) - Area under the plasma concentration-time curve in one dosing interval (AUCtau) (Time Frame - 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 PC14586 (INN: rezatapopt)

5. Phase 1 Monotherapy: PK profile of PC14586 (INN: rezatapopt) - Trough observed concentrations (Ctrough/Ctau) (Time Frame - 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 PC14586 (INN: rezatapopt)

6. Phase 1 Monotherapy: Blood plasma assessment to describe the concentration of PC14586 and metabolite (M1) when PC14586 (INN: rezatapopt) is administered orally. (Time Frame - Approximately 12 months per patient (75 months for Phase 1 and Phase 2)):
Blood plasma concentration

7. Phase 1 Monotherapy (Dose Escalation): Overall Response Rate per RECIST v1.1 or PCWG3 modified RECIST v1.1 (Time Frame - 41 months for study (end of Phase 1)):
Evaluation of preliminary anti-tumor activity of PC14586 (INN: rezatapopt) as a single agent

8. Phase 1 Monotherapy (Dose Escalation): Time to Response per RECIST v1.1 or PCWG3 modified RECIST v1.1 (Time Frame - 41 months for study (end of Phase 1)):
Evaluation of preliminary anti-tumor activity of PC14586 (INN: rezatapopt) as a single agent

9. Phase 1 Monotherapy (Dose Escalation): Duration of Response per RECIST v1.1 or PCWG3 modified RECIST v1.1 (Time Frame - 41 months for study (end of Phase 1)):
Evaluation of preliminary anti-tumor activity of PC14586 (INN: rezatapopt) as a single agent

10. Phase 1 Monotherapy (Dose Escalation): Disease Control Rate per RECIST v1.1 or PCWG3 modified RECIST v1.1 (Time Frame - 41 months for study (end of Phase 1)):
Evaluation of preliminary anti-tumor activity of PC14586 (INN: rezatapopt) as a single agent

11. Phase 1 Monotherapy (Dose Escalation): Progression Free Survival per RECIST v1.1 or PCWG3 modified RECIST v1.1 (Time Frame - 41 months for study (end of Phase 1)):
Evaluation of preliminary anti-tumor activity of PC14586 (INN: rezatapopt) as a single agent

12. Phase 1 Monotherapy (Dose Escalation): Overall Survival (Time Frame - 41 months for study (end of Phase 1)):
Evaluation of preliminary anti-tumor activity of PC14586 (INN: rezatapopt) as a single agent

13. Phase 1b Combination Therapy: PK profile of PC14586 (INN: rezatapopt) in combination with pembrolizumab - Peak concentration (Cmax) (Time Frame - Approximately 12 months per patient (30 months for treatment arm)):
Pharmacokinetic parameters will be determined by non-compartmental methods using pharmacokinetic profile of PC14586 (INN: rezatapopt)

14. Phase 1b Combination Therapy: PK profile of PC14586 (INN: rezatapopt) in combination with pembrolizumab - Time of peak concentration (Tmax) (Time Frame - Approximately 12 months per patient (30 months for treatment arm)):
Pharmacokinetic parameters will be determined by non-compartmental methods using pharmacokinetic profile of PC14586 (INN: rezatapopt)

15. 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) (Time Frame - Approximately 12 months per patient (30 months for treatment arm)):
Pharmacokinetic parameters will be determined by non-compartmental methods using pharmacokinetic profile of PC14586 (INN: rezatapopt)

16. 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) (Time Frame - Approximately 12 months per patient (30 months for treatment arm)):
Pharmacokinetic parameters will be determined by non-compartmental methods using pharmacokinetic profile of PC14586 (INN: rezatapopt)

17. Phase 1b Combination Therapy: PK profile of PC14586 (INN: rezatapopt) in combination with pembrolizumab - Trough observed concentrations (Ctrough/Ctau) (Time Frame - Approximately 12 months per patient (30 months for treatment arm)):
Pharmacokinetic parameters will be determined by non-compartmental methods using pharmacokinetic profile of PC14586 (INN: rezatapopt)

18. 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. (Time Frame - Approximately 12 months per patient (30 months for treatment arm)):
Blood plasma concentration

19. Phase 1b Combination Therapy: Overall Response Rate per RECIST v1.1, iRECIST, or PCWG3 as assessed by Investigator and as assessed by independent review (Time Frame - 30 months for study (end of Phase 1b)):
Evaluation of anti-tumor activity of PC14586 (INN: rezatapopt) in combination with pembrolizumab

20. Phase 1b Combination Therapy: Time to Response per RECIST v1.1, iRECIST, or PCWG3 as assessed by Investigator and as assessed by independent review (Time Frame - 30 months for study (end of Phase 1b)):
Evaluation of anti-tumor activity of PC14586 (INN: rezatapopt) in combination with pembrolizumab

21. Phase 1b Combination Therapy: Duration of Response per RECIST v1.1, iRECIST, or PCWG3 as assessed by Investigator and as assessed by independent review (Time Frame - 30 months for study (end of Phase 1b)):
Evaluation of anti-tumor activity of PC14586 (INN: rezatapopt) in combination with pembrolizumab

22. Phase 1b Combination Therapy: Disease Control Rate per RECIST v1.1, iRECIST, or PCWG3 as assessed by Investigator and as assessed by independent review (Time Frame - 30 months for study (end of Phase 1b)):
Evaluation of anti-tumor activity of PC14586 (INN: rezatapopt) in combination with pembrolizumab

23. Phase 1b Combination Therapy: Overall Survival (Time Frame - 30 months for study (end of Phase 1b)):
Evaluation of anti-tumor activity of PC14586 (INN: rezatapopt) in combination with pembrolizumab

24. Phase 1b Combination Therapy: Determine the number and type of adverse events to characterize the safety of PC14586 (INN: rezatapopt) (Time Frame - 30 months for study (end of Phase 1b)):
Number of participants with treatment related adverse events

25. Phase 1b Combination Therapy: Progression Free Survival per RECIST v1.1, iRECIST, or PCWG3 as assessed by Investigator and as assessed by independent review (Time Frame - 30 months for study (end of Phase 1b)):
Evaluation of anti-tumor activity of PC14586 (INN: rezatapopt) in combination with pembrolizumab

26. Phase 2 Monotherapy: PK profile of PC14586 (INN: rezatapopt) - Time of peak concentration (Tmax) (Time Frame - 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 PC14586 (INN: rezatapopt)

27. Phase 2 Monotherapy: PK profile of PC14586 (INN: rezatapopt) - Peak concentration (Cmax) (Time Frame - 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 PC14586 (INN: rezatapopt)

28. 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) (Time Frame - 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 PC14586 (INN: rezatapopt)

29. Phase 2 Monotherapy: PK profile of PC14586 (INN: rezatapopt) - Area under the plasma concentration-time curve in one dosing interval (AUCtau) (Time Frame - 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 PC14586 (INN: rezatapopt)

30. Phase 2 Monotherapy: PK profile of PC14586 (INN: rezatapopt) - Trough observed concentrations (Ctrough/Ctau) (Time Frame - 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 PC14586 (INN: rezatapopt)

31. Phase 2 Monotherapy: Blood plasma assessment to describe the concentration of PC14586 (INN: rezatapopt) and metabolite (M1) when PC14586 (INN: rezatapopt) is administered orally. (Time Frame - Approximately 12 months per patient (75 months for Phase 1 and Phase 2)):
Blood plasma concentration

32. Phase 2 Monotherapy (Dose Expansion): Determine the number and type of adverse events to characterize the safety of PC14586 (INN: rezatapopt) (Time Frame - 34 months for study (end of Phase 2)):
Number of participants with treatment related adverse events

33. Phase 2 Monotherapy (Dose Expansion): Overall Response Rate across all cohorts per RECIST v1.1 as assessed by Investigator (Time Frame - 34 months for study (end of Phase 2)):
Evaluation of anti-tumor activity of PC14586 (INN: rezatapopt) as a single agent

34. Phase 2 Monotherapy (Dose Expansion): Overall Response Rate in ovarian cancer cohort per RECIST v1.1 as assessed by Investigator (Time Frame - 34 months for study (end of Phase 2)):
Evaluation of anti-tumor activity of PC14586 (INN: rezatapopt) as a single agent

35. 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 (Time Frame - 34 months for study (end of Phase 2)):
Evaluation of anti-tumor activity of PC14586 (INN: rezatapopt) as a single agent

36. 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 (Time Frame - 34 months for study (end of Phase 2)):
Evaluation of anti-tumor activity of PC14586 (INN: rezatapopt) as a single agent

37. 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 (Time Frame - 34 months for study (end of Phase 2)):
Evaluation of anti-tumor activity of PC14586 (INN: rezatapopt) as a single agent

38. 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 (Time Frame - 34 months for study (end of Phase 2)):
Evaluation of anti-tumor activity of PC14586 (INN: rezatapopt) as a single agent

39. 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 (Time Frame - 34 months for study (end of Phase 2)):
Evaluation of anti-tumor activity of PC14586 (INN: rezatapopt) as a single agent

40. 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 (Time Frame - 34 months for study (end of Phase 2)):
Evaluation of anti-tumor activity of PC14586 (INN: rezatapopt) as a single agent

41. 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 (Time Frame - 34 months for study (end of Phase 2)):
Evaluation of anti-tumor activity of PC14586 (INN: rezatapopt) as a single agent

42. 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 (Time Frame - 34 months for study (end of Phase 2)):
Evaluation of anti-tumor activity of PC14586 (INN: rezatapopt) as a single agent

43. Phase 2 Monotherapy (Dose Expansion): Overall Survival in ovarian cancer cohort (Time Frame - 34 months for study (end of Phase 2)):
Evaluation of anti-tumor activity of PC14586 (INN: rezatapopt) as a single agent

44. Phase 2 Monotherapy (Dose Expansion): Overall Survival across all cohorts (Time Frame - 34 months for study (end of Phase 2)):
Evaluation of anti-tumor activity of PC14586 (INN: rezatapopt) as a single agent

45. Phase 2 Monotherapy (Dose Expansion): Quality of life assessment (Time Frame - 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

Studien-Arme

  • Experimental: Phase 1 Monotherapy Dose Escalation
    Multiple dose levels of daily oral PC14586 (INN: 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 PC14586 (INN: rezatapopt) to recommend a Phase 2 dose (RP2D).
  • Experimental: Phase 1b Combination Therapy Dose Escalation, Part 1
    Multiple dose levels of daily oral PC14586 (INN: 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 PC14586 (INN: rezatapopt) when administered in combination with pembrolizumab.
  • Experimental: 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.
  • Experimental: Phase 1b Combination Therapy Dose Expansion, PD(L)-1 relapsed/refractory 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 relapsed/refractory patients.
  • Experimental: 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.
  • Experimental: 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.
  • Experimental: 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.
  • Experimental: 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.
  • Experimental: 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.

Geprüfte Regime

  • PC14586 (rezatapopt):
    First-in-class, oral, small molecule p53 reactivator selective for the p53 Y220C mutation.
  • pembrolizumab (KEYTRUDA® / MK-3475 / KEYNOTE-D79 / MK-3475-D79 / ):
    Participants receive pembrolizumab 200 mg by intravenous (IV) infusion over 30 minutes.

Quelle: ClinicalTrials.gov


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