NCT06630234

A Master Protocol to Evaluate DCC-3009 in Gastrointestinal Stromal Tumor (GIST)

A Master Protocol for the Multi-cohort, Open-label, Phase 1/2 Study of DCC-3009 in Participants With Gastrointestinal Stromal Tumor (GIST)

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Deciphera Pharmaceuticals, LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this Phase 1/2 master protocol study is to evaluate if DCC-3009 is safe, tolerable and works effectively in the treatment of GIST. The study will use a modular approach with each module being defined according to therapy: DCC-3009 alone or DCC-3009 in combination with other anticancer therapies. Each module will be conducted in 2 parts: Part 1 (Dose Escalation) and Part 2 (Dose Expansion). Participants will be treated in 28-day treatment cycles with an estimated duration of up to 2 years.

Conditions

• Gastrointestinal Stromal Tumor (GIST)

Interventions

Type	Name	Description
DRUG	DCC-3009	Administered orally

Timeline

• Start date: 2024-12-10
• Primary completion: 2028-05-01
• Completion: 2028-05-01
• First posted: 2024-10-08
• Last updated: 2026-02-05

Locations

10 sites across 1 country: United States

Regulatory

• FDA-regulated drug study