Access to Bezuclastinib and Sunitinib for Patients with Gastrointestinal Stromal Tumors

Sponsor: Cogent Biosciences, Inc.

Expanded Access
Sponsor score: 60

ClinicalTrials ID:NCT06948955

Provider View

This program offers access to the investigational drug bezuclastinib, used together with sunitinib, for patients with gastrointestinal stromal tumors (GIST) who have no other suitable treatment options. This combination targets common mutations in GIST.

Patient Parameters

Program Overview

The goal of this program is to provide patients with gastrointestinal stromal tumors (GIST) access to bezuclastinib, an investigational drug, in combination with sunitinib. This treatment is intended for patients who do not have other effective treatment options. The combination of these drugs works by targeting and inhibiting mutations in the KIT gene, which are often found in GIST.

Eligibility Criteria

Inclusion Criteria

  • Able to provide written consent and agree to the program's assessments.
  • 18 years or older.
  • Able to swallow tablets.
  • Have a confirmed diagnosis of advanced, metastatic, or inoperable GIST.
  • Have not tolerated imatinib or have had disease progression after imatinib treatment.
  • Meet acceptable laboratory test results.

Exclusion Criteria

  • Eligible for or participating in a current bezuclastinib clinical trial.
  • Have had a bad reaction to sunitinib in the past.
  • Previously participated in a bezuclastinib trial.
  • Have ongoing severe side effects from previous treatments.
  • Have specific genetic mutations (PDGFR or SDH deficiency).
  • Pregnant or breastfeeding.

Other criteria may apply.

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