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Protocol # 20-544

Status

Recruiting

Description

This study will assess the safety and tolerability of multiple dose levels of PC14586 in participants with advanced solid tumors containing a p53 Y220C mutation.

Condition

  • Advanced Solid Tumor
  • Advanced Malignant Neoplasm
  • Metastatic Cancer
  • Metastatic Solid Tumor

Interventions

  • PC14586

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
  • Establish the maximum tolerated dose (MTD) (Phase 1)
  • Establish the Recommended Phase 2 Dose (RP2D) (Phase 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)
  • Response rate assessment to assess clinical activity / efficacy of PC14586 (Phase 1)

Enrollment

130

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

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.