Peak: CGT9486+Sunitinib vs. Sunitinib in GIST

 

Trial name: CGT9486 (Bezuclastinib)+Sunitinib vs. Sunitinib alone in advanced GIST
Agents: CGT9486 (Bezuclastinib), Sunitinib
Phase III
Status Closed for recruitment, but active
Sponsor Cogent Biosciences, Inc.

 

This is a Phase 3, open-label, international, multicenter study of CGT9486 in combination with sunitinib in locally advanced, metastatic, and/or unresectable GIST.

Further information can be found on clinicaltrials.gov.

 

WHO is the trial for?
  • Adult patients with confirmed diagnosis of locally advanced, metastatic, and/or unresectable GIST
  • Patients with a GIST tumor that has progressed under imatinib
  • Overall health status of the patient has to be good (ECOG performance status 0 or 1)
  • Excluded are patients with PDGFR driving mutations or succinate dehydrogenase deficiency (SDH deficiency)

WHAT is the key question that this trial is attempting to answer?

 The study wants to assess whether the combination of CGT9486 (Bezuclastinib)+Sunitinib is superior in efficacy compared to Sunitinib alone.

Bezuclastinib is a tyrosine kinase inhibitor that selectively targets a specific range of KIT mutations. This includes some mutations that sunitinib does not work against. The key question this trial aims to answers is if the combination of bezuclastinib and sunitinib have the potential to provide complementary coverage across a number of mutations in the KIT gene.

WHY patients might want to participate?

 This clinical trial offers patients an opportunity to access a new therapy strategy. This trial will further support the research in GIST and potentially help other patients with this disease.

The trial might or might not have benefit in your individual case.

WHEN will the trial be open?

 The study is active, but closed for recruitment.

WHERE is the trial available?

 The trial is currently active in the US, Australia, Canada, Denmark, France, Germany, the Republic of Korea, Netherlands, Sweden and Taiwan.

Please check for current information here.

Study contact:

  • Cogent Biosciences
  • Phone: 617-945-5576
  • Email: peakinfo@cogentbio.com

STUDY DESIGN: What does the study look like?

 The trial will be conducted in two parts:

  • Part 1a: Participants will receive bezuclastinib in combination with sunitinib
  • Part 1b: Participants will receive bezuclastinib in combination with sunitinib after initially being randomized to receive either bezuclastinib or sunitinib for 2 weeks.
  • Part 2: Participants will be randomly divided (by a computer) to either receive sunitinib alone or a combination of bezuclastinib and sunitinib. Patients whose disease progresses under sunitinib alone during the study, may cross over to receive bezuclastinib in combination with sunitinib.

HOW do I get more information?

 Patient organizations supporting GIST and/or sarcoma patients in your country may offer additional information about the trial, current recruitment status, and key contacts. Click here for a list of patient organizations serving GIST and/or sarcoma patients. If there are no such organization in your country, please email us for more information: info@sarcoma-patients.org

Disclaimer: This is a patient-friendly summary of the clinical trial which has been provided for informational purposes only. Patients should consult their physician about any clinical trial opportunity.

Merken