Clinical trial · Interventional
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)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastrointestinal Stromal Tumor (GIST) | Gastrointestinal Stromal Tumor | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| DCC-3009 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- DCC-3009 Module A
- description
- Participants will receive DCC-3009 in 28 day cycles in Module A Part 1 dose escalation and Part 2 dose expansion.
- interventionNames
- Drug: DCC-3009
Primary outcomes (2)
- measure
- Number of Participants with Dose-Limiting Toxicities (DLT) (Part 1 Escalation)
- timeFrame
- Cycle 1 (28 Days)
- description
- DLTs assessed for each dose level.
- measure
- Objective Response Rate (ORR) (Part 2 Expansion)
- timeFrame
- Baseline to Progressive Disease (PD), Death due to Any Cause, or Start of New Antitumor Therapy (Estimated up to 24 months)
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: Module A Part 1 (Escalation): * Any participant with histologically or cytologically confirmed advanced/unresectable or metastatic GIST with documented KIT or platelet-derived growth factor receptor alpha (PDGFRA) mutation, who has progressed on or was intolerant to at least 1 approved tyrosine kinase inhibitor (TKI) regimen in the advanced/metastatic setting * Have at least 1 measurable lesion as defined by mRECIST, v1.1 * Have Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1 * Adequate organ function, bone marrow function, and electrolytes * All participants agree to comply with the contraception requirements * Have a life expectancy of more than 3 months Exclusion Criteria: * Received systemic anticancer therapy or radiotherapy within 14 days prior to first dose of study drug * Prior or concurrent malignancy that requires treatment or is expected to require treatment for active cancer * Has known active central nervous system (CNS) metastases or an active primary CNS cancer * History or presence of clinically relevant cardiovascular abnormalities * Major surgery within 28 days of the first dose of study drug * Had systemic arterial thrombotic or embolic events within 6 months prior to the first dose of study drug * Had venous thrombotic events (e.g., deep vein thrombosis) or venous thrombotic embolic events (e.g., pulmonary embolism) within 1 month prior to the first dose of study drug * Known allergy or hypersensitivity to any component of the study drug * Malabsorption syndrome or other illness that could affect oral absorption * Any other clinically significant comorbidities
References
Publications (0)
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