Phase 1  | 
Enrolling
 | Investigational Drug

NCT04956640

Colorectal Cancer, NSCLC, or Other Advanced Solid Tumors

KRAS G12C Inhibitor


A Phase 1a/1b Study of LY3537982 in Patients With KRAS G12C-Mutant Advanced Solid Tumors*

show modal icon NCT04956640
Key Inclusion Criteria
  • Measurable disease per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)
  • Evidence of KRAS G12C mutation in tumor tissue or circulating tumor DNA
  • Histological or a cytologically proven diagnosis of locally advanced, unresectable, and/or metastatic cancer and meet cohort-specific criteria
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Adequate organ function
  • Discontinued all previous treatments for cancer with resolution of any significant ongoing adverse events (AEs)
  • Able to swallow capsules/tablets
  • Must agree and adhere to contraceptive use, if applicable
Key Exclusion Criteria
  • Disease suitable for local therapy administered with curative intent
  • Active, ongoing, or untreated infection
  • Serious preexisting medical condition(s) that, in the judgment of the investigator, would preclude participation in this study
  • Serious cardiac conditions
  • A second active primary malignancy or have been diagnosed and/or treated for an additional malignancy within 3 years prior to enrollment
  • Symptomatic central nervous system (CNS) malignancy or metastasis and/or carcinomatous meningitis. Patients with treated CNS metastases are eligible for this study if they are not currently receiving corticosteroids in excess of 10 mg per day prednisone/prednisolone (or equivalent) and their disease is asymptomatic and radiographically stable for at least 30 days
  • Prior treatment with any KRAS G12C small molecule inhibitor, except in certain NSCLC cohorts where such prior therapy is allowed as per protocol
  • For cohorts B2, B3, and B5/C1, patients treated with drugs known to be strong inhibitors or inducers of cytochrome P450 3A (CYP3A)
  • The following patients will be excluded from cohort B4:
    • Experienced certain serious side effects with prior immunotherapy
    • Have an active autoimmune disease that has required systemic anti-autoimmune treatment in the past 2 years
    • Have undergone prior allogeneic hematopoietic stem cell transplantation within the last 5 years
    • Have received a live vaccine within 30 days prior to the first dose of study drug
  • The following patients will be excluded from cohorts B7 & C3:
    • Clinically significant cardiac disease or risk factors at screening
  • Pregnant, breastfeeding, or expecting to conceive or father children within the projected duration of the trial through 180 days after the last dose of study medication
  • Known allergic reaction against any of the components of the study treatments
*
This clinical trial is being conducted globally.
LY3537982 is administered PO.
Abemaciclib is administered PO.
§
Erlotinib is administered PO.
Pembrolizumab is administered intravenously (IV).
Temuterkib is administered PO.
#
LY3295668 is administered PO.
**
Cetuximab is administered IV.
††
TNO155 is administered PO.
Contact the Loxo Oncology at Lilly Clinical Trial Team

Visit www.clinicaltrials.gov for more information on this trial.

The safety and efficacy of the agents under investigation have not been established. There is no guarantee that the agents will receive regulatory approval and become commercially available for the uses being investigated.