A Master Protocol for the Multi-Cohort, Phase I/II Study of DCC-3116 in Combination With Anticancer Therapies in Participants With Advanced Malignancies

Study Identifier:
DCC-3116-01-002
CT.gov Identifier:
NCT05957367
EudraCT Identifier:
202250000000
EU Trial (CTIS) Number:
2024-516476-15-00
Study Contact Information:
(210) 593-5651 or [email protected]
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Study Summary

This is a Phase 1/2, multicenter, open-label (unless otherwise specified in a combination-specific module) study of DCC-3116 in combination with anticancer therapies. Modules within the master protocol are defined according to different combinations of DCC-3116 with other anticancer agents.

Part 1 will use safety, pharmacokinetics, pharmacodynamics, preliminary efficacy, tolerability and a Bayesian optimal interval design to identify the RP2D for part 2 and the maximum tolerated dose.

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
  • Gastrointestinal stromal tumor
    • Phase
    The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
    I/II
    Sex
    Female & Male
    Age
    18+ years
    Study Drug
  • Drug: Experimental: Dose Escalation (Part 1, Module A)
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  • Drug: Other Names:
  • Drug: ASCO 2024:
    • Study Status
    Indicates the current recruitment status or the expanded access status
    Recruiting

    Requirements information
    Inclusion criteria
    • Inclusion Criteria:
    • Male or female ≥18 years of age
    • Module A: Part 1 and Part 2:
    • Module A Part 1 and Part 2 DCC-3116 combination closed on January 8, 2024, with no participants enrolled.
    • Module B: Only for Part 1 (Safety/Dose-finding):
    • Pathologically confirmed diagnosis of GIST with a KIT or platelet-derived growth factor receptor alpha (PDGFRA) mutation
    • Must have progressed on at least one approved systemic regimen given in the locally advanced or metastatic setting or have documented intolerance to it
    • Must not have received prior ripretinib treatment
    • Module B: Only for Part 2 (Expansion)
    • Pathologically confirmed GIST with documented mutation in KIT exon 11
    • Must have progressed on imatinib given in the locally advanced or metastatic setting or have been intolerant to imatinib and may not have received additional systemic therapy for GIST
    • Measurable disease
    • Must have a life expectancy of more than 3 months and an ECOG performance status of 0-1
    • Adequate organ function and bone marrow reserve based on laboratory assessments performed at Screening
    • Must provide a fresh tumor biopsy and an archival tumor tissue sample, if available
    • Must agree to provide an on treatment biopsy
    Exclusion criteria
    • Must not have received the following within the specified time periods prior to the first dose of study drug:
    • Medications, including anticancer therapies, that are known strong or moderate inhibitors or inducers of CYP3A4 or P-glycoprotein (P-gp) including certain herbal medications (eg, St. John's wort): 14 days or 5×the half-life of the medication (whichever is longer)
    • Other anticancer therapies and any investigational therapies with a known safety and PK profile: 14 days or 5×the half-life of the medication (whichever is shorter)
    • Investigational therapies with unknown safety and PK profile: 28 days. If there is enough data on the investigational therapy to assess the risk for drug-drug interactions and late toxicities of prior therapy as low, the Sponsor's Medical Monitor may approve a shorter washout of 14 days
    • Grapefruit or grapefruit juice: 14 days
    • Have not recovered from all clinically relevant toxicities from prior therapy
    • New York Heart Association Class III or IV heart disease, active ischemia, or any other uncontrolled cardiac condition, clinically significant cardiac arrhythmia requiring therapy, uncontrolled hypertension, congestive heart failure, or myocardial infarction within 6 months prior to the first dose of study drug
    • Symptomatic central nervous system (CNS) metastases or presence of leptomeningeal disease
    • Malabsorption syndrome
    • Bone disease that requires ongoing treatment or has required treatment within 6 months of signing the informed consent form
    • Radiation for indications other than bone disease must have been completed 4 weeks prior to first dose of study drug, unless it consisted of limited field palliative radiation, including whole brain radiation, which must have been completed at least 2 weeks prior to first dose of study drug
    • Major surgery within 4 weeks of the first dose of study drug
    • Active HIV, Hepatitis B or Hepatitis C infection

    Clinical Study Information for Healthcare Providers

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    Study Locations

    Location
    Investigator
    Status
    Condition(s) Treated at Site
    Location
    START Midwest
    Grand Rapids, MI, United States, 49546
    Investigator
    Sreenivasa Chandana
    Status
    Recruiting
    Condition(s) Treated at Site
    Gastrointestinal stromal tumor