Study on SMARCA4/2 Inhibitor for POU2F3-Positive Small Cell Lung Cancer

Sponsor: Dana-Farber Cancer Institute

Sponsor score: 40

ClinicalTrials ID:NCT07551635

Provider View

This clinical trial is testing a new drug, FHD-286, to see if it is safe and effective for treating small cell lung cancer that has a specific marker called POU2F3. Participants will take the drug daily in 21-day cycles.

Patient Parameters

Program Overview

This study is exploring the effects of a new drug, FHD-286, on small cell lung cancer that shows a specific marker called POU2F3. The trial aims to find out if FHD-286 can help shrink tumors in patients who have already tried at least one platinum-based chemotherapy. Participants will take the drug by mouth once a day in 21-day cycles. The main goal is to see how well the drug works in reducing cancer size.

Description

This trial is for patients with advanced small cell lung cancer that has a specific marker, POU2F3, and has not responded to previous platinum-based chemotherapy. The drug being tested, FHD-286, is not yet approved by health authorities for this type of cancer. Participants will undergo various tests, including scans, blood tests, and heart function tests, to monitor their health and the drug's effects. About 20 people are expected to join this study, which is supported by Foghorn Therapeutics, Inc. The study involves taking FHD-286 daily and attending regular check-ups to assess the drug's impact on the cancer.

Eligibility Criteria

Inclusion Criteria

  • Adults aged 18 or older who agree to participate.
  • Diagnosed with advanced small cell lung cancer that has worsened after platinum-based treatment.
  • Cancer must show more than 50% POU2F3 marker.
  • Must have measurable cancer based on specific criteria.
  • Good overall health with a performance status of 0 or 1.
  • Meet specific blood and organ function requirements.
  • Agree to follow dietary and other study guidelines.
  • Women of childbearing age and men with partners of childbearing age must use effective birth control during the study and for 90 days after the last dose.
  • Must be able to swallow pills and understand the study details.

Exclusion Criteria

  • Have not fully recovered from side effects of previous cancer treatments, except for hair loss.
  • Currently receiving other experimental treatments.
  • Have untreated or symptomatic brain metastases.
  • Taking certain medications that interact with the study drug.
  • Using proton pump inhibitors unless approved by the study doctor.
  • Taking high doses of steroids or other immune-suppressing drugs unless stable and approved.
  • Pregnant or breastfeeding women.
  • Planning to become pregnant within a year of starting the study.
  • Have active infections or other cancers needing treatment.
  • Have heart conditions or other serious health issues that could affect participation.
  • Have digestive issues that affect drug absorption.
  • Allergic to any part of the study drug.
  • Previously treated with similar drugs.

Locations

FACILITYZIPCITYSTATE
Dana-Farber Cancer Institute02215BostonMassachusetts

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