What is CGT9486 studying for Gastrointestinal Stromal Tumors (GIST)?

CGT9486 is being studied in combination with sunitinib to evaluate its effects in patients with advanced or metastatic GIST. The trial aims to compare this combination to sunitinib alone to see how it may affect disease progression. Cogent Biosciences, Inc. is sponsoring this research to better understand treatment options for GIST.

Who may be eligible for this Gastrointestinal Stromal Tumors clinical trial?

Adults aged 18 years or older with locally advanced, metastatic, or unresectable GIST may be eligible. Participants should have disease progression on or intolerance to imatinib and measurable tumors. Both males and females can participate. Please review eligibility criteria for more details.

Is there any cost to participate in this Gastrointestinal Stromal Tumors clinical trial?

Study-related care, including the study drugs and all trial visits, is provided at no cost. However, personal travel expenses may vary and are not guaranteed to be covered. Participants can expect their treatment and evaluations to be supported as part of the study.

Actively Recruiting

Phase 3

Age: 18Years +

All Genders

ID05208047

Phase 3 Study Comparing CGT9486 Plus Sunitinib Versus Sunitinib Alone for Advanced or Metastatic Gastrointestinal Stromal Tumors

Led by Cogent Biosciences, Inc. · Updated on 2026-06-16

482

Participants Needed

126

Research Sites

222 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the combination of CGT9486 and sunitinib compared to sunitinib alone in patients with locally advanced, unresectable, or metastatic Gastrointestinal Stromal Tumors GIST. This Phase 3, open-label international trial involves multiple parts, including dose confirmation, drug interaction assessments, and efficacy comparisons. The study also includes substudies focusing on drug-drug interaction potential and first-line treatment in patients with specific genetic mutations KIT exon 9. Approximately 482 patients will participate across these parts.

CONDITIONS

Brief Title

(Peak) A Phase 3 Randomized Trial of CGT9486+Sunitinib vs. Sunitinib in Subjects With Gastrointestinal Stromal Tumors

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Histologically confirmed locally advanced, metastatic, or unresectable Gastrointestinal Stromal Tumors (GIST)
Molecular pathology report available; if not, tumor tissue sample required for mutation evaluation
Documented disease progression on or intolerance to imatinib
Prior treatment requirements vary by study part (at least 1 prior therapy, at least 2 prior TKIs, or no prior systemic therapy for first-line substudy)
At least 1 measurable lesion according to mRECIST v1.1
Eastern Cooperative Oncology Group (ECOG) status of 0 to 2 (or 0 to 1 for first-line substudy)
Clinically acceptable laboratory results within specified limits

You will not qualify if you...

Known platelet-derived growth factor receptor (PDGFR) mutations or succinate dehydrogenase deficiency
Clinically significant cardiac disease
Major surgeries within 4 weeks before first dose of study drug
Gastrointestinal issues that prevent adequate drug absorption
Any active bleeding excluding hemorrhoidal or gum bleeding
Positive for HIV 1 or 2, hepatitis B surface antigen, or hepatitis C virus antibody
Active, uncontrolled systemic infections at screening
Recent use of strong CYP3A4 inhibitors or inducers
Use of sunitinib within 3 weeks prior to study (in some parts)

Research Team

Cogent Biosciences

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