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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
120
Administered orally
HonorHealth
Scottsdate, Arizona, United States
RECRUITINGUC San Diego Moores Cancer Center
La Jolla, California, United States
RECRUITINGUniversity of Colorado Anschutz Medical Campus
Aurora, Colorado, United States
RECRUITINGMayo Clinic Florida
Jacksonville, Florida, United States
RECRUITINGUniversity of Miami - Sylvester Comprehensive Cancer Center
Miami, Florida, United States
RECRUITINGDana Farber Cancer Institute
Boston, Massachusetts, United States
RECRUITINGSTART Midwest
Grand Rapids, Michigan, United States
RECRUITINGMayo Clinic Rochester
Rochester, Minnesota, United States
RECRUITINGMemorial Sloan Kettering Cancer Center
New York, New York, United States
RECRUITINGVanderbilt University-Ingram Cancer Center
Nashville, Tennessee, United States
RECRUITINGNumber of Participants with Dose-Limiting Toxicities (DLT) (Part 1 Escalation)
DLTs assessed for each dose level.
Time frame: Cycle 1 (28 Days)
Objective Response Rate (ORR) (Part 2 Expansion)
ORR is the percentage of participants with confirmed complete response (CR) or confirmed partial response (PR) based on Modified Response Evaluation Criteria in Solid Tumors (mRECIST), v1.1.
Time frame: Baseline to Progressive Disease (PD), Death due to Any Cause, or Start of New Antitumor Therapy (Estimated up to 24 months)
Objective Response Rate (ORR) (Part 1 Escalation)
ORR is the percentage of participants with confirmed complete response (CR) or confirmed partial response (PR) based on mRECIST, v1.1.
Time frame: Baseline to Progressive Disease (PD), Death due to Any Cause, or Start of New Antitumor Therapy (Estimated up to 24 months)
Duration of Response (DOR)
DOR for participants with confirmed CR or confirmed PR based on mRECIST, v1.1, defined as the time interval from the time that the measurement criteria are first met for CR or PR (whichever is first recorded) until the first date that the disease progression is objectively documented or death, whichever occurs first.
Time frame: First Recorded CR or PR until PD or Death (Estimated up to 24 months)
Progression-Free Survival (PFS)
PFS is the time from initiation of treatment until documented disease progression per mRECIST, v1.1, or death, whichever occurs first.
Time frame: Initiation of Treatment to PD or Death (Estimated up to 24 months)
Overall Survival (OS)
OS is the time from initiation of treatment to the date of death from any cause.
Time frame: Initiation of Treatment to Death from Any Cause (Estimated up to 24 months)
Pharmacokinetics (PK): Maximum observed plasma drug concentration (Cmax)
Cmax
Time frame: Estimated up to 24 months
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