The Evaluation of PC14586 in Patients With Advanced Solid Tumors Harboring a p53 Y220C Mutation

• Status: Recruiting
• Trial end date: 2025-12-15
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: PMV Pharmaceuticals, Inc

Criteria

Inclusion Criteria:

• 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

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 (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