A Master Protocol to Evaluate DCC-3009 in Gastrointestinal Stromal Tumor (GIST)
A Master Protocol to Evaluate DCC-3009 in Gastrointestinal Stromal Tumor (GIST)
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.
Colon,
Esophageal,
GIST,
Gastric/Gastroesophageal,
Gastrointestinal,
Liver,
Pancreatic,
Rectal
Phase I/II
Adults
Mol. targeted/Immunotherapy/Biologics
DCC-3009
Keedy, Vicki
National
Vanderbilt University
09-17-2025
Eligibility
18 Years and older
ALL
false
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
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
