Clinical trial · no report yet · Phase 3

NCT05208047

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

NCT05208047 ↗
Recruiting
Cogent Biosciences, Inc.
Focused

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Preliminary discovery

Commentary in our index that names this trial so far

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The trial

ClinicalTrials.gov

Official title: A Phase 3 Randomized, Open-Label, Multicenter Clinical Study of CGT9486+Sunitinib vs. Sunitinib in Subjects With Locally Advanced, Unresectable, or Metastatic Gastrointestinal Stromal Tumors
Phase: Phase 3
Status: Recruiting
Conditions: Advanced Gastrointestinal Stromal Tumors; Metastatic Cancer
Interventions: CGT9486; CGT9486; Sunitinib; Sunitinib; Midazolam; CGT9486; Sunitinib; CGT9486; Sunitinib
Arms: Part 1a · Experimental
Part 2 - Experimental Group · Experimental
Part 2 - Control Group · Active comparator
Part 1b - DDI Cohort 1 · Experimental
Part 1b - DDI Cohort 2 · Experimental
DDI Substudy (Midazolam) · Experimental
GIST 1L Substudy · Experimental
Enrollment: 482 (estimated)
Primary outcomes: Part 1a - pharmacokinetics - Cmax
Part 1a - pharmacokinetics - AUC
Part 1b - pharmacokinetics - Cmax
Part 1b - pharmacokinetics - AUC
Part 1b - pharmacokinetics - Tmax
Part 2 - Progression Free Survival (PFS)
DDI Substudy - pharmacokinetics - AUC
DDI Substudy - pharmacokinetics - Cmax
Sponsor: Cogent Biosciences, Inc.
Start: Apr 14, 2022
Primary completion: Sep 30, 2025
Results posted: No
Registry record: NCT05208047 · updated Jun 16, 2026