General Information

Age Group

Adults

Status

Recruiting

Protocol Number

NCT04956640

Background Information

This research study is being done to test the safety of an investigational treatment called LY3537982. LY3537982 is an investigational (or experimental) drug, taken orally, that may treat certain cancers. It was designed to target a particular abnormality that can occur in some types of cancer cells.

Offered At

Inova Schar Cancer Institute
8081 Innovation Park Drive
Fairfax, VA 22031

Principal Investigator

Nagla Karim, MD

Eligibility Information

  • ≥ 18 years of age.
  • Must have measurable disease per RECIST v1.1.
  • Individuals must have disease with evidence of KRAS G12C mutation in tumor tissue or circulating tumor
    DNA. 
  • Individuals must have a 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.
  • Individuals must be able to swallow capsule/tablet.

Ineligibility Information

  • Individual has an active fungal, bacterial, and/or active untreated viral infection, including human immunodeficiency virus (HIV) or viral (A, B, or C) hepatitis.
  • Individual has a serious pre-existing medical condition(s) that, in the judgment of the Investigator, would preclude participation in this study, including interstitial lung disease (ILD) or severe dyspnea at rest and uncontrolled disease-related pericardial effusion or pleural effusion.
  • Individual has clinically significant, active cardiovascular disease, unstable angina, or history of myocardial infarction within 6 months prior to planned start of LY3537982, or QT interval corrected for heart rate of ≥ 470 msec. Note that individuals with implanted pacemakers may enter study without meeting QTc criteria due to nonevaluable measurement.
  • Individual has a second active primary malignancy or have been diagnosed and/or treated for an additional malignancy within 3 years prior to enrollment with the exception of curatively-treated basal cell carcinoma of the skin, nonmetastatic prostate cancer treated with observation only, squamous cell carcinoma of the skin, and/or curatively resected in situ cervical and/or breast cancers.
  • Individual has a known allergic reaction against any of the components of the study treatments.