Study on PC14586 for Patients with Advanced Solid Tumors with a TP53 Y220C Mutation (PYNNACLE)

Sponsor: PMV Pharmaceuticals, Inc

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04585750

Provider View

This clinical trial is testing the safety and effectiveness of a new drug, PC14586, alone and in combination with pembrolizumab, for treating advanced solid tumors with a specific TP53 Y220C mutation.

Patient Parameters

Program Overview

The study aims to evaluate the safety, tolerability, and effectiveness of different doses of PC14586, a new oral drug, in patients with advanced solid tumors that have a TP53 Y220C mutation. The trial will also test PC14586 in combination with pembrolizumab, an immunotherapy drug, to see if this combination is safe and effective.

Description

PC14586 is a new type of drug taken by mouth that targets a specific mutation in the TP53 gene, known as Y220C, found in some advanced solid tumors. The study is divided into different phases:

  • Phase 1 Monotherapy: The goal is to find the highest dose of PC14586 that patients can tolerate and to understand how the drug behaves in the body. Researchers will also look at how safe the drug is and if it shows any signs of working against the cancer.

  • Phase 1b Combination Therapy: This phase will test PC14586 together with pembrolizumab to find the best dose combination. The safety and initial effectiveness of this combination will be evaluated.

  • Phase 2 Monotherapy: This phase will focus on how well PC14586 works at the recommended dose, especially in patients with ovarian cancer and other types of cancer. Researchers will also continue to monitor safety and how the drug affects patients' quality of life.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older, or 12 to 17 years old with special approval.
  • Have advanced solid tumors with a TP53 Y220C mutation.
  • Be in good general health with an ECOG status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Have previously received cancer treatment but the disease has progressed.
  • Have good organ function.
  • Have measurable disease according to specific criteria.

Additional for Phase 1b (PC14586 + pembrolizumab combination):

  • Must not have received anti-PD-1/PD-L1 treatment before or must have progressed on such treatment.
  • Have measurable disease.

Exclusion Criteria

  • Have received anti-cancer therapy within 21 days before starting the study drug.
  • Have had radiotherapy within 28 days before starting the study drug.
  • Have a primary brain tumor or history of certain brain conditions.
  • Have heart conditions like recent heart attack or uncontrolled high blood pressure.
  • Are taking certain medications that affect the heart or drug absorption.
  • Have a history of organ transplant.
  • Have active, uncontrolled infections like Hepatitis B, C, or HIV.

Additional for Phase 2 (PC14586 monotherapy):

  • Have a known KRAS mutation.

Additional for Phase 1b (PC14586 + pembrolizumab combination):

  • Have had severe reactions to pembrolizumab or similar drugs.
  • Have received a live vaccine recently.
  • Have an active autoimmune disease needing treatment in the past 2 years.
  • Have a history of lung inflammation or active lung disease.
  • Have an active infection needing treatment.
  • Have previously received PC14586.

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