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Protocol # 20-544

Status

Recruiting

Description

This study will assess the safety, tolerability, and efficacy of multiple dose levels of PC14586 alone and in combination with pembrolizumab in participants with advanced solid tumors containing a TP53 Y220C mutation.

Condition

  • Advanced Solid Tumor
  • Advanced Malignant Neoplasm
  • Metastatic Cancer
  • Metastatic Solid Tumor
  • Lung Cancer
  • Ovarian Cancer
  • Endometrial Cancer
  • Prostate Cancer
  • Colorectal Cancer
  • Breast Cancer
  • Other Cancer

Interventions

  • PC14586
  • Pembrolizumab

Phase

Phase 1/Phase 2

Study Type

Interventional

Further Study Details

Primary Outcome:

  • Determine the number and type of adverse events to characterize the safety of PC14586
  • Determine the number and type of adverse events to characterize the safety of PC14586 when administered in combination with pembrolizumab
  • Establish the maximum tolerated dose (MTD) (Phase 1)
  • Establish the maximum tolerated dose (MTD) of PC14586 when administered in combination with pembrolizumab (Phase 1b, Part 1)
  • Establish the Recommended Phase 2 Dose (RP2D) (Phase 1)
  • Establish the Recommended Phase 2 Dose (RP2D) of PC14586 when administered in combination with pembrolizumab (Phase 1b, Part 1)
  • Response rate assessment to evaluate the clinical activity / efficacy of PC14586 (Phase 2)

Secondary Outcome:

  • Blood plasma assessment to characterize the pharmacokinetics (PK) of PC14586 and metabolites (Phase 1 and 2)
  • Blood plasma assessment to characterize the pharmacokinetics (PK) of PC14586 and metabolites when administered in combination with pembrolizumab (Phase 1b, Part 1 and 2)
  • Preliminary efficacy of PC14586 using tumor response criteria to assess clinical activity / efficacy of PC14586 (Phase 1)
  • Preliminary efficacy of PC14586 using tumor response criteria to assess clinical activity / efficacy of PC14586 when administered in combination with pembrolizumab (Phase 1b, Part 1 and 2)
  • Efficacy evaluation of PC14586 using tumor response criteria to assess clinical activity / efficacy of PC14586 (Phase 2)
  • Efficacy evaluation of PC14586 using tumor response criteria to assess clinical activity / efficacy of PC14586 when administered in combination with pembrolizumab (Phase 1b, Part 1 and 2)
  • Quality of life assessment

Enrollment

181

Study Start Date

October 29, 2020

Eligibility

  • Gender:     All
  • Minimum age:     12 Years
  • Maximum age:     N/A
  • Healthy volunteers:     No

Sponsors

PMV Pharmaceuticals, Inc

Source

PMV Pharmaceuticals, Inc

Official title

A Phase 1/2 Open-label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of PC14586 in Patients With Advanced Solid Tumors Harboring a p53 Y220C Mutation (PYNNACLE)

Clinicaltrials.gov Identifier

NCT04585750

     

Source: Clinicaltrials.gov. Through our founding membership in the Dana-Farber/Harvard Cancer Center, an NCI-designated Comprehensive Cancer Center, these clinical trials are conducted at the Massachusetts General Hospital Cancer Center and may be available at other partner institutions.