A Phase 1a/1b Trial of LY3962673 in Participants With KRAS G12D-Mutant Solid Tumors

Study Identifier:
J5J-OX-JZZA
CT.gov Identifier:
NCT06586515
EudraCT Identifier:
202452000000
EU Trial (CTIS) Number:
2024-516440-25-00
Study Contact Information:
(210) 593-5651 or [email protected]
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Study Summary

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.

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.
  • Pancreas
  • Non-Small Cell Lung Cancer
  • Bowel (Colorectal)
    • 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
    Sex
    Female & Male
    Age
    18+ years
    Study Drug
  • Drug: Experimental: Phase 1a: LY3962673 Dose Escalation
    • Read More
  • Drug: Experimental: Phase 1b: LY3962673 Dose Expansion
  • Drug: Drug: Cetuximab
  • Drug: Drug: Gemcitabine
  • Drug: Drug: nab-paclitaxel
  • Drug: Drug: Oxaliplatin
  • Drug: Drug: leucovorin
  • Drug: Drug: Irinotecan
  • Drug: Drug: 5-fluorouracil
  • Drug: Experimental: Experimental: Phase 1a: LY3962673 Monotherapy
    • Study Status
    Indicates the current recruitment status or the expanded access status
    Recruiting

    Requirements information
    Inclusion criteria
    • * Have Histological or cytologically proven diagnosis of locally advanced, unresectable, and/or metastatic cancer and measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
    • * Have evidence of KRAS G12D mutation in tumor tissue or circulating tumor DNA
    • * Have an ECOG performance status of ≤ 1
    • * Must have received ≥ 1 prior line of systemic chemotherapy for advanced or metastatic disease
    • * Participants with asymptomatic or treated CNS disease may be eligible.
    Exclusion criteria
    • Have known active CNS metastases and/or carcinomatous meningitis.
    • Have any unresolved toxicities from prior therapy greater than National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 Grade 1.
    • Have significant cardiovascular disease as unstable angina or acute coronary syndrome, history of myocardial infarction, known reduced left ventricular ejection fraction.
    • Have active uncontrolled systemic bacterial, viral, fungal, or parasitic infection.
    • Have known active hepatitis B virus (HBV) and hepatitis C virus (HCV).
    • Have other active malignancy unless in remission with life expectancy greater than (>) 2 years.

    Clinical Study Information for Healthcare Providers

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    Study Locations

    Location
    Investigator
    Status
    Condition(s) Treated at Site
    Location
    START Madrid, Spain (FJD)
    Madrid, Spain, 28040
    Investigator
    Victor Moreno Garcia
    Status
    Recruiting
    Condition(s) Treated at Site
    Pancreas
    Non-Small Cell Lung Cancer
    Bowel (Colorectal)
    Location
    START San Antonio
    San Antonio, TX, United States, 78229
    Investigator
    Amita Patnaik
    Status
    Recruiting
    Condition(s) Treated at Site
    Pancreas
    Non-Small Cell Lung Cancer
    Bowel (Colorectal)
    Location
    START Barcelona
    Barcelona, Spain, 08023
    Investigator
    Tatiana Hernandez Guerrero
    Status
    Recruiting
    Condition(s) Treated at Site
    Pancreas
    Non-Small Cell Lung Cancer
    Bowel (Colorectal)
    Location
    START Midwest
    Grand Rapids, MI, United States, 49546
    Investigator
    Nehal Lakhani
    Status
    Recruiting
    Condition(s) Treated at Site
    Pancreas
    Non-Small Cell Lung Cancer
    Bowel (Colorectal)
    Location
    START Dublin
    Dublin, Ireland, D07 R2WY
    Investigator
    Austin Duffy
    Status
    Recruiting
    Condition(s) Treated at Site
    Pancreas
    Non-Small Cell Lung Cancer
    Bowel (Colorectal)