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

Conditions

• Advanced Gastrointestinal Stromal Tumors
• Metastatic Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• CGT9486 — DRUG
  Participants will receive CGT9486 orally until study stopping rules are met.
• CGT9486 — DRUG
  Participants will receive CGT9486 until steady state then both CGT9486 and sunitinib orally until study stopping rules are met.
• Sunitinib — DRUG
  Participants will receive sunitinib until steady state then both sunitinib and CGT9486 orally until study stopping rules are met.
• Sunitinib — DRUG
  Participants will receive sunitinib orally until study stopping rules are met.
• Midazolam — DRUG
  Participants will receive a single-dose of midazolam on Day 1 and Day 16
• CGT9486 — DRUG
  Participants will receive CGT9486 orally starting on Day 2 until study stopping rules are met.
• Sunitinib — DRUG
  Participants will receive CGT9486 until steady state then both sunitinib and CGT9486 orally until study stopping rules are met.
• CGT9486 — DRUG
  Participants will receive sunitinib until steady state then both CGT9486 and sunitinib orally until study stopping rules are met.
• Sunitinib — DRUG
  Participants will receive sunitinib orally starting on Day 16 until study stopping rules are met.

Study Details

This is a Phase 3, open-label, international, multicenter study of CGT9486 in combination with sunitinib. This is a multi-part study that will enroll approximately 482 patients. Part 1 consists of two evaluations: 1) confirming the dose of an updated formulation of CGT9486 to be used in subsequent parts in approximately 20 patients who have received at least one prior line of therapy for Gastrointestinal Stromal Tumors (GIST) and 2) evaluating the potential for drug-drug interactions between CGT9486 and sunitinib in approximately 18 patients who have received at least two prior tyrosine kinase inhibitors (TKIs) for GISTs. The second part of the study will enroll approximately 388 patients who are intolerant to, or who failed prior treatment with imatinib only and will compare the efficacy of CGT9486 plus sunitinib to sunitinib alone with patients being randomized in a 1:1 manner. This study also contains two substudies: 1) a drug-drug interactions (DDI) substudy will investigate the potential for CGT9486 to be a Cytochrome P450 (CYP)3A4 inducer in approximately 16 patients who have received at least one prior line of therapy for GIST and 2) a substudy intended to test the efficacy of bezuclastinib and sunitinib as first-line (1L) treatment of GIST in approximately 40 participants with KIT exon 9 mutations and no prior systemic therapy (with the exception of up to 10 subjects with ongoing imatinib therapy of ≤4 weeks).

Key Dates

Start date

Apr 14, 2022

Status verified

Jun 2026

Primary completion

Sep 30, 2025

Completion

Jan 31, 2030

Study Design

Enrollment

482 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Part 1a
  CGT9486 plus sunitinib 37.5 mg QD
• Experimental: Part 2 - Experimental Group
  CGT9486 plus sunitinib 37.5 mg QD
• Active Comparator: Part 2 - Control Group
  sunitinib 37.5 mg QD
• Experimental: Part 1b - DDI Cohort 1
  CGT9486 plus sunitinib 37.5 mg QD
• Experimental: Part 1b - DDI Cohort 2
  sunitinib 37.5 mg QD plus CGT9486
• Experimental: DDI Substudy (Midazolam)
  Midazolam, CGT9486, sunitinib
• Experimental: GIST 1L Substudy
  CGT9486, sunitinib

Primary Outcome Measure

Part 1a - pharmacokinetics - Cmax [ Time Frame: 16 days ]

Central Contacts

• Cogent Biosciences
  617-945-5576
  [email protected]

Locations (36)

Find similar trials in Birmingham, AL

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