Summary

Eligibility
for people ages 12 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
estimated completion

Description

Summary

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.

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

Details

PC14586 is a first-in-class, oral, small molecule p53 reactivator that is selective for the p53 Y220C mutation. The trial will be conducted in 2 parts: dose escalation (Phase 1) and dose expansion (Phase 2). The primary objective of Phase 1 is to establish the maximum tolerated dose / recommended dose of PC14586 to treat participants with advanced solid tumors harboring a p53 Y220C mutation. Secondary objectives of Phase 1 are to characterize the pharmacokinetic properties of the investigational drug, its safety and tolerability, and to assess the overall response rate (ORR). The primary objective of Phase 2 is to assess the ORR in participants with advanced solid tumors harboring a p53 Y220C mutation as determined by blinded independent central review. Secondary objectives of Phase 2 include the safety, pharmacokinetic properties, and efficacy of PC14586 at the recommended dose.

Keywords

Advanced Solid Tumor Advanced Malignant Neoplasm Metastatic Cancer Metastatic Solid Tumor PC14586 p53 Y220C Phase 1 Phase 1/2 PMV PMV Pharma p53 mutation TP53 TP53 mutation p53 mutant p53 reactivator Neoplasms

Eligibility

You can join if…

Open to people ages 12 years and up

  • At least 18 years of age or 12 to 17 years of age after adequate adult safety data become available
  • Advanced solid malignancy with a p53 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

You CAN'T join if...

  • 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 (Phase 1, Phase 2 Cohort A)
  • History of leptomeningeal disease or spinal cord compression
  • Brain metastases, unless neurologically stable and do not require steroids to treat associated neurological symptom
  • 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

Locations

  • UCSF Helen Diller Family Comprehensive Cancer Center accepting new patients
    San Francisco California 94143 United States
  • USC Norris Comprehensive Cancer Center accepting new patients
    Los Angeles California 90033 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
PMV Pharmaceuticals, Inc
ID
NCT04585750
Phase
Phase 1/2
Study Type
Interventional
Last Updated