MOONRAY-01, A Study of LY3962673 in Participants With KRAS G12D-Mutant Solid Tumors

Part of paid clinical trials in Duarte, California.

Sponsor
Eli Lilly and Company
Study ID
NCT06586515
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

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

Interventions

  • LY3962673 — DRUG
    Administered orally.
  • Cetuximab — DRUG
    Administered intravenously.
  • Gemcitabine — DRUG
    Administered intravenously.
  • nab-paclitaxel — DRUG
    Administered intravenously.
  • Oxaliplatin — DRUG
    Administered intravenously.
  • leucovorin — DRUG
    Administered intravenously.
  • Irinotecan — DRUG
    Administered intravenously.
  • 5-fluorouracil — DRUG
    Administered intravenously.

Study Details

The main purpose of this study is to assess safety \& tolerability and antitumor activity of LY3962673 as monotherapy and in combination with other chemotherapy agents in participants with KRAS G12D-mutant advanced solid tumor types. The study is expected to last approximately 5 years.

Key Dates

Start date
Sep 12, 2024
Status verified
Apr 2026
Primary completion
Mar 31, 2029
Completion
Mar 31, 2029

Study Design

Enrollment
630 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Phase 1a: LY3962673 Dose Escalation
    Escalating doses of LY3962673 administered orally.
  • Experimental: Phase 1b: LY3962673 Dose Expansion
    LY3962673 administered orally either alone or in combination with other chemotherapy agents.
  • Experimental: Experimental: Phase 1a: LY3962673 Monotherapy
    LY3962673 administered orally

Primary Outcome Measure

Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration [ Time Frame: Baseline through 5 years ]

Central Contacts

  • Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
    1-317-615-4559
    [email protected]
  • Physicians interested in becoming principal investigators please contact
    [email protected]

Locations (25)

FacilityCityStateZIPSite coordinators
City of HopeDuarteCalifornia91010-
University of California, Los Angeles (UCLA)Santa MonicaCalifornia90404-
Sarah Cannon Research Institute at HealthOneDenverColorado80218-
Sibley Memorial HospitalWashington D.C.District of Columbia20016-
Florida Cancer Specialists - Lake Nona - Sarah Cannon Research InstituteOrlandoFlorida32827-
Emory University School of MedicineAtlantaGeorgia30322-
Community Health NetworkIndianapolisIndiana46250-
Dana-Farber Cancer InstituteBostonMassachusetts02215-
Massachusetts General HospitalBostonMassachusetts02114-
Barbara Ann Karmanos Cancer InstituteDetroitMichigan48201-
South Texas Accelerated Research Therapeutics (START) MidwestGrand RapidsMichigan49546-
David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-
New York University (NYU) Langone Medical CenterNew YorkNew York10016-
Duke University Medical CenterDurhamNorth Carolina27710-
University of Cincinnati (UC) - Cancer InstituteCincinnatiOhio45267-
Cleveland ClinicClevelandOhio44195-
University of Pittsburgh Medical Center (UPMC) - Hillman Cancer CenterPittsburghPennsylvania15232-
Sarah Cannon Research InstituteNashvilleTennessee37203-
USO - US Oncology Research NetworkNashvilleTennessee37203-
Vanderbilt University School of MedicineNashvilleTennessee37215-
MD Anderson Cancer CenterHoustonTexas77030-
South Texas Accelerated Research Therapeutics (START)San AntonioTexas78229-
Huntsman Cancer InstituteSalt Lake CityUtah84112-
Fred Hutchinson Cancer CenterSeattleWashington98109-
University of Wisconsin - Carbone Cancer CenterMadisonWisconsin53792-

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City of Hope· Duarte, CAUniversity of California, Los Angeles (UCLA)· Santa Monica, CASarah Cannon Research Institute at HealthOne· Denver, COSibley Memorial Hospital· Washington D.C., DCFlorida Cancer Specialists - Lake Nona - Sarah Cannon Research Institute· Orlando, FLEmory University School of Medicine· Atlanta, GA

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