Clinical trial NCT06630234: A Master Protocol to Evaluate DCC-3009 in Gastrointestinal Stromal Tumor (GIST)
Official title: A Master Protocol for the Multi-cohort, Open-label, Phase 1/2 Study of DCC-3009 in Participants With Gastrointestinal Stromal Tumor (GIST)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Gastrointestinal Stromal Tumor (GIST)
Keywords: PDGFRA mutations
KIT mutations
Lead sponsor: Deciphera Pharmaceuticals, LLC
Sponsor class: INDUSTRY
First posted: 2024-10-08
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants with Dose-Limiting Toxicities (DLT) (Part 1 Escalation)
timeFrame: Cycle 1 (28 Days)
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)
Secondary outcomes:
measure: Objective Response Rate (ORR) (Part 1 Escalation)
timeFrame: Baseline to Progressive Disease (PD), Death due to Any Cause, or Start of New Antitumor Therapy (Estimated up to 24 months)
measure: Duration of Response (DOR)
timeFrame: First Recorded CR or PR until PD or Death (Estimated up to 24 months)
measure: Progression-Free Survival (PFS)
timeFrame: Initiation of Treatment to PD or Death (Estimated up to 24 months)
measure: Overall Survival (OS)
timeFrame: Initiation of Treatment to Death from Any Cause (Estimated up to 24 months)
measure: Pharmacokinetics (PK): Maximum observed plasma drug concentration (Cmax)
timeFrame: Estimated up to 24 months
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: HonorHealth
state: Arizona
city: La Jolla
country: United States
facility: UC San Diego Moores Cancer Center
state: California
city: Jacksonville
country: United States
facility: Mayo Clinic Florida
state: Florida
city: Miami
country: United States
facility: University of Miami - Sylvester Comprehensive Cancer Center
state: Florida
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
city: Grand Rapids
country: United States
facility: START Midwest
state: Michigan
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Deciphera Pharmaceuticals, LLC
name: Clinical Team
role: STUDY_DIRECTOR
References: