Study on the Effectiveness and Safety of FORE8394 in Patients with Cancer with BRAF Changes

Sponsor: Fore Biotherapeutics

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05503797

Provider View

This clinical trial is testing a new drug, plixorafenib, to see if it can help treat patients with certain types of cancer that have specific changes in the BRAF gene. The study includes different groups of patients with various types of tumors, including rare solid tumors, melanoma, thyroid cancer, and brain tumors.

Patient Parameters

Program Overview

The purpose of this study is to find out if the drug plixorafenib is effective in treating patients with advanced or spreading solid tumors, or recurring brain tumors that have specific changes in the BRAF gene. The study is divided into four parts, each focusing on different types of cancer or genetic changes.

Eligibility Criteria

Exclusion Criteria

Subprotocol A:

  • Patients with certain genetic changes related to NF1 or RAS genes.
  • Patients whose cancer shows signs of previous treatment effects rather than a main genetic change driving the cancer.
  • Previous treatment with specific MAPK inhibitors for advanced cancer.
  • Patients with certain types of brain tumors who had previous RAF/BRAF inhibitor treatment can join if their tumor did not grow during or shortly after stopping the treatment.
  • Patients with active RAS mutations.
  • Patients with serious health issues that would prevent them from following the study plan.
  • Participation in another study of an experimental drug or device.
  • Digestive issues that could affect how the body absorbs the study drug.
  • Use of certain medications or foods that affect how the body processes drugs.

Subprotocol B:

  • Previous treatment with BRAF, ERK, or MEK inhibitors.
  • Known or suspected genetic changes related to NF1 or RAS genes.
  • Serious health issues that would prevent following the study plan.
  • Active infections needing treatment.
  • Participation in another study of an experimental drug or device.
  • Digestive issues affecting drug absorption.
  • Liver function changes due to previous treatments.
  • Use of certain medications or foods affecting drug processing.

Subprotocol C:

  • Diagnosis of specific types of colorectal or pancreatic cancer.
  • Cancer spread to the brain.
  • Previous treatment with BRAF, ERK, or MEK inhibitors.
  • Known or suspected genetic changes related to NF1 or RAS genes.
  • Serious health issues preventing study participation.
  • Active infections needing treatment.
  • Participation in another study of an experimental drug or device.
  • Digestive issues affecting drug absorption.
  • Liver function changes due to previous treatments.
  • Use of certain medications or foods affecting drug processing.

Subprotocol D:

  • Known or suspected genetic changes related to NF1 or RAS genes.
  • Cancer spread to the brain.
  • Serious health issues preventing study participation.
  • Active infections needing treatment.
  • Participation in another study of an experimental drug or device.
  • Digestive issues affecting drug absorption.
  • Liver function changes due to previous treatments.
  • Use of certain medications or foods affecting drug processing.

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