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

{ "Phase 3 Study of CGT9486 + Sunitinib for Advanced GIST", "This Phase 3 study is testing a new combination treatment, CGT9486 and sunitinib, for people with advanced gastrointestinal stromal tumors (GIST). Researchers want to see how well this combination works compared to sunitinib alone. The study will also look at how CGT9486 and sunitinib interact in the body. You may be eligible if you have locally advanced, metastatic (spread to other parts of the body), or unresectable GIST. The study aims to enroll about 482 participants and will measure drug levels in the body as a primary goal.", "design": "This is an open-label (you and your doctors will know which treatment you are receiving), international, multi-part Phase 3 study involving approximately 482 participants.", "commitments": "Participants will receive CGT9486 and/or sunitinib orally until study stopping rules are met. Some participants will also receive a single dose of midazolam on Day 1 and Day 16.", "compensation": "Not stated in the trial record.", "follow_up": "Drug levels (Cmax and AUC) will be measured at 14 or 16 days, but overall follow-up duration is not specified.", }

Study design
Not specified.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Not specified.

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NCT05208047

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

Recruiting
PHASE3Ages 18+InterventionalTreatment
Cogent Biosciences, Inc.
~482 participants
Updated 2026-06-16 on ClinicalTrials.gov
What's tested:CGT9486SunitinibMidazolam

At a glance

Recruiting sites
8 of 126 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Part 1a - pharmacokinetics - Cmax
Measured over 16 days
+7 more outcomes measured
Advanced Gastrointestinal Stromal Tumors
Metastatic Cancer
126 sites across 48 states
Italy12
Spain11
France8
United Kingdom7
Germany6
Florida5
Taiwan5
California4

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Eligibility criteria

Inclusion

DDI Substudy/Part 1a: Treatment with ≥1 prior lines of therapy for GIST
Part 1b: Treatment with ≥2 prior TKI for GISTs
Part 2: Prior treatment with imatinib only
GIST 1L Substudy: No prior systemic therapy for GIST including adjuvant therapy. Exception: up to 10 subjects with ongoing imatinib therapy of ≤4 weeks 4. Have at least 1 measurable lesion according to mRECIST v1.1 (Part1a, Part 1b, Part 2, GIST 1L Substudy) 5. Eastern Cooperative Oncology Group (ECOG) Status
0 to 2 (Part 1a, Part 1b, Part 2, DDI Substudy)
0 to 1 (GIST 1L Substudy) 6. Have clinically acceptable local laboratory screening results (clinical chemistry and hematology) within certain limits
  • Part 1a - pharmacokinetics - Cmax16 days

    Maximum plasma concentration (Cmax)

  • Part 1a - pharmacokinetics - AUC16 days

    Area under the plasma concentration-time curve (AUC)

  • Part 1b - pharmacokinetics - Cmax14 days

    Maximum plasma concentration (Cmax)

  • Part 1b - pharmacokinetics - AUC14 days

    Area under the plasma concentration-time curve (AUC)

  • Part 1b - pharmacokinetics - Tmax14 days

    Time to maximum observed plasma concentration (Tmax)

  • Part 2 - Progression Free Survival (PFS)Approximately 48 months

    Time from first dose to documented disease progression or death due to any cause, whichever occurs first

  • DDI Substudy - pharmacokinetics - AUC16 days

    Area under the plasma concentration-time curve (AUC)

  • DDI Substudy - pharmacokinetics - Cmax14 days

    Maximum plasma concentration (Cmax)