Study of LY3537982 in Cancer Patients With a Specific Genetic Mutation (KRAS G12C)

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Eli Lilly and Company
Study ID
NCT04956640
Phase
PHASE1/PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • LY3537982 — DRUG
    Oral
  • Pembrolizumab — DRUG
    Intravenous
  • Cetuximab — DRUG
    Intravenous
  • Pemetrexed — DRUG
    Intravenous
  • Cisplatin — DRUG
    Intravenous
  • Carboplatin — DRUG
    Intravenous

Study Details

The purpose of this study is to find out whether the study drug, LY3537982, is safe and effective in cancer patients who have a specific genetic mutation (KRAS G12C). Patients must have already received or were not able to tolerate the standard of care, except for specific groups who have not had cancer treatment. The study will last up to approximately 4 years.

Key Dates

Start date
Jul 19, 2021
Status verified
Sep 2025
Primary completion
Apr 30, 2027
Completion
Apr 30, 2027

Study Design

Enrollment
540 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: LY3537982 (Dose Escalation)
    LY3537982 administered orally.
  • Experimental: LY3537982 (Dose Expansion)
    LY3537982 administered orally either alone or with another investigational agent.
  • Experimental: LY3537982 (Dose Optimization)
    LY3537982 administered orally either alone or with another investigational agent

Primary Outcome Measure

Phase 1a: To determine the recommended phase 2 dose (RP2D) of LY3537982 monotherapy [ Time Frame: Cycle 1 (21 Days) ]

Locations (26)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35233-
USC Norris Cancer HospitalLos AngelesCalifornia90033-
Chao Family Comprehensive Cancer Ctr.OrangeCalifornia92868-
Yale-New Haven HospitalNew HavenConnecticut06510-
AdventHealth OrlandoOrlandoFlorida32803-
Florida Cancer SpecialistsSarasotaFlorida34236-
Community Health NetworkIndianapolisIndiana46250-
Indiana Univ Melvin & Bren Simon Cancer CenterIndianapolisIndiana46202-
Mary Bird Perkins Cancer CenterBaton RougeLouisiana70809-
Massachusetts General HospitalBostonMassachusetts02114-
Dartmouth-Hitchcock Medical CenterLebanonNew Hampshire03756-
NYU Langone Health- Long IslandMineolaNew York11501-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-
NYU LangoneNew YorkNew York10016-
The University of North Carolina at Chapel HillChapel HillNorth Carolina27599-
Novant Health Cancer Institute - ElizabethCharlotteNorth Carolina28204-
Novant Health Cancer Institute - ForsythWinston-SalemNorth Carolina27103-
Fox Chase Cancer CenterPhiladelphiaPennsylvania19111-2497-
UPMC Hillman Cancer CenterPittsburghPennsylvania15232-
Sarah Cannon Cancer CenterNashvilleTennessee37203-
Vanderbilt Univeristy School of MedicineNashvilleTennessee37212-6303-
South Texas Accelerated Research Therapeutics (START)San AntonioTexas78229-3307-
START Mountain RegionWest Valley CityUtah84119-
Inova Health System IRBFairfaxVirginia22031-
USO-Virginia Cancer Specialists, PCFairfaxVirginia22031-
University of Wisconsin-Madison Hospital and Health ClinicMadisonWisconsin53792-4108-

Find similar trials in Birmingham, AL

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By specialty
OncologyGI oncologyGynecologic oncologyWomen's health
By research site
University of Alabama at Birmingham· Birmingham, ALUSC Norris Cancer Hospital· Los Angeles, CAChao Family Comprehensive Cancer Ctr.· Orange, CAYale-New Haven Hospital· New Haven, CTAdventHealth Orlando· Orlando, FLFlorida Cancer Specialists· Sarasota, FL

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