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).

Status

Recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-504251-27-00

Acronym

PMV-586-101

Enrollment

105

Registered

2024-04-24

Start date

2024-05-27

Completion date

Unknown

Last updated

2026-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Locally Advanced or Metastatic Solid Tumors Harboring a TP53 Y220C Mutation

Brief summary

1. Overall Response Rate (ORR) per Blinded Independent Central Review (BICR) assessment (RECIST v1.1) across all cohorts., 2. ORR per BICR assessment (RECIST v1.1) in ovarian cancer cohort.

Detailed description

1. ORR across all cohorts- RECIST v1.1 as assessed by Investigator, 2. ORR in ovarian cancer cohort - RECIST v1.1 as assessed by Investigator, 3. Incidence of AEs and SAEs, and changes between baseline and post-baseline laboratory assessments, ECGs, ECOG performance status, vital signs, and physical exams. Toxicities will be graded using CTCAE v5.0 (NCI, 2017), 4. TTR, DoR, DCR at 6, 12, 18, and 24 weeks, PFS across all cohorts and in ovarian cancer only - RECIST v1.1 as assessed by BICR - RECIST v1.1 as assessed by Investigator, 5. OS across all cohorts and in ovarian cancer only, 6. Rezatapopt concentrations (and concentrations of metabolites), 7. Plasma PK parameters: Cmax, Tmax, AUC0-t, AUCtau, Ctrough/Ctau, 8. EORTC QLQ-C30

Interventions

DRUGPC14586

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
1. Overall Response Rate (ORR) per Blinded Independent Central Review (BICR) assessment (RECIST v1.1) across all cohorts., 2. ORR per BICR assessment (RECIST v1.1) in ovarian cancer cohort.	—

Secondary

Measure	Time frame
1. ORR across all cohorts- RECIST v1.1 as assessed by Investigator, 2. ORR in ovarian cancer cohort - RECIST v1.1 as assessed by Investigator, 3. Incidence of AEs and SAEs, and changes between baseline and post-baseline laboratory assessments, ECGs, ECOG performance status, vital signs, and physical exams. Toxicities will be graded using CTCAE v5.0 (NCI, 2017), 4. TTR, DoR, DCR at 6, 12, 18, and 24 weeks, PFS across all cohorts and in ovarian cancer only - RECIST v1.1 as assessed by BICR - RECIST v1.1 as assessed by Investigator, 5. OS across all cohorts and in ovarian cancer only, 6. Rezatapopt concentrations (and concentrations of metabolites), 7. Plasma PK parameters: Cmax, Tmax, AUC0-t, AUCtau, Ctrough/Ctau, 8. EORTC QLQ-C30	—

Measure

Time frame

—

Countries

France, Germany, Italy, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026