Study on PRT3789 and Pembrolizumab for Advanced or Metastatic Solid Tumors with SMARCA4 Mutation

Sponsor: Prelude Therapeutics

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06682806

Provider View

This clinical trial is testing a new treatment combining PRT3789 and pembrolizumab to see if it is safe and effective for patients with advanced or metastatic solid tumors that have a specific SMARCA4 mutation.

Patient Parameters

Program Overview

The study aims to evaluate the safety and effectiveness of a new treatment combining PRT3789, a drug targeting SMARCA2, with pembrolizumab, an immunotherapy drug. This treatment is for patients with advanced or metastatic solid tumors that have a SMARCA4 mutation. The study is divided into two parts: the first part will determine the safe dose of PRT3789 to use with pembrolizumab, and the second part will assess how well the treatment works in shrinking tumors.

Description

This clinical trial is exploring a new treatment for patients with advanced or metastatic solid tumors that have a specific genetic mutation called SMARCA4. The treatment combines two drugs: PRT3789, which targets a protein involved in tumor growth, and pembrolizumab, an immunotherapy that helps the immune system attack cancer cells. The study is open-label, meaning both doctors and participants know what treatment is being given, and it takes place at multiple centers.

The trial has two parts. In the first part, researchers will determine the best dose of PRT3789 to use with pembrolizumab by monitoring safety and side effects. In the second part, they will evaluate how well the treatment works by measuring tumor response rates and how long the response lasts. The study will include 46 to 60 patients, depending on the dose selected in the first part.

Eligibility Criteria

Inclusion Criteria

  • Willing and able to attend all study visits and follow the treatment plan, including providing informed consent.
  • Must have advanced, recurrent, or metastatic solid tumors with a SMARCA4 mutation and have either not responded to standard treatments or be ineligible for them.
  • For Part 1: Must have a confirmed solid tumor with any SMARCA4 mutation or absence of SMARCA4 protein.
  • For Part 2: Must have esophageal cancer or non-small cell lung cancer (NSCLC) with a harmful SMARCA4 mutation or absence of SMARCA4 protein.
  • Must have measurable disease as determined by scans.
  • Must provide a tumor tissue sample, either archived or from a new biopsy.
  • Must have controlled blood pressure and adequate organ function.
  • Patients with HIV must have it well-controlled with medication.

Exclusion Criteria

  • Must have recovered from any side effects of previous cancer treatments to a mild level before starting the study.
  • Cannot have other serious medical or psychiatric conditions that would interfere with the study.
  • Cannot have tumors with a SMARCA2 mutation or loss of protein expression.
  • Cannot have uncontrolled or symptomatic brain metastases or certain types of meningitis.
  • Cannot have a history of lung diseases like pneumonitis.
  • Cannot have an immune system disorder.
  • Cannot have another progressing cancer or one that needed treatment in the last 3 years.
  • Cannot have had previous treatments targeting T-cell receptors.
  • Cannot be taking certain medications that affect the liver enzyme CYP3A4 or St. John's Wort.
  • Cannot have had treatments targeting SMARCA2/SMARCA4.
  • Cannot be pregnant, breastfeeding, or planning to become pregnant during the study.

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