Promising Results from Recent GIST Clinical Trials

At The Life Raft Group Canada, we want to ensure you stay informed about the latest advancements and treatment options available for advanced or metastatic Gastrointestinal Stromal Tumours (GIST).

There is currently a very active and highly promising clinical trial portfolio right here in Canada at Princess Margaret Hospital (PMH) / UHN. Many in our community have been following the exciting global data surrounding the combination of Sutent (sunitinib) + Bezuclastinib *see links below from Cogent Biosciences). While this combination is not yet commercially available in Canada, we have excellent news: advanced therapies—including a brand-new cohort for that very combination—are coming to PMH and other locations in Canada through clinical trials.

Newer targeted agents, such as Velzatinib and DCC-3009, are designed as “pan-inhibitors” to fight multiple KIT mutations simultaneously, making them highly attractive options for overcoming treatment resistance.

Active GIST Clinical Trials at PMH (As of June 2026)

Please review the current clinical trial dashboard outlined below. If you or a loved one are considering next steps in your treatment plan, these trials are worth discussing with your oncology team.

1st-Line Therapy (For newly diagnosed / treatment-naïve patients)

• Velzatinib vs. Imatinib (Phase 3)
  • Status: Open
  • About: This randomized, active-comparator controlled trial directly challenges Imatinib (Gleevec) as the traditional frontline standard of care. Recent data shows very encouraging results for Velzatinib in shrinking advanced tumours early in treatment.
• Bezuclastinib + Sunitinib (Extension Cohort)
  • Status: Opening August 2026
  • Patient Population: Restricted specifically to patients with KIT Exon 9 mutations.
  • About: This evaluates the highly anticipated combination approach to target frontline standard treatment limits.

2nd-Line Therapy (For patients whose disease progressed on Imatinib)

• Velzatinib vs. Sunitinib (Phase 3)
  • Status: Open
  • About: A randomized trial comparing Velzatinib against standard second-line Sunitinib (Sutent). Velzatinib is designed to hit both primary mutations and the secondary resistance mutations that typically cause other drugs to stop working.

3rd-Line Therapy & Beyond (For patients who have tried 2 or more prior TKIs)

• DCC-3009 (Phase 1/2 Master Protocol)
  • Status: Opening Late Summer 2026
  • Patient Population: Advanced/metastatic GIST with 2 or more prior lines of therapy.
  • About: This is a next-generation, highly potent “switch-control” KIT inhibitor. It acts as a broad-spectrum blocker against a wide range of drug-resistant mutations to safely halt tumour progression when other options have been exhausted.

What Should You Do Next?

Clinical trials offer early access to tomorrow’s treatments today, under the close supervision of Canada’s leading GIST specialists.

• Discuss with your Oncologist: Bring this update to your next appointment to see if you meet the specific eligibility criteria for any of these protocols.
• Ask for a Referral: If you are not currently a patient at Princess Margaret Hospital, your local oncologist can easily submit a referral or inquiry to the PMH clinical trial team.
• Reach Out: The clinical team at PMH welcomes inquiries and patient referrals at any time to answer your questions.

Please note: Eligibility criteria and site availability may vary. Always confirm the exact details with local trial coordinators