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. This abnormality (called KRAS G12C mutation) is tested in advance. LY3537982 is expected to be more effective in patients with this abnormality. This study will be the first time LY3537982 will be taken by humans.

Offered At

Inova Schar Cancer Institute
8081 Innovation Park Dr.
Fairfax, VA 22031

A department of Inova Fairfax Hospital

Eligibility Information

  • 18 years of age or older
  • Individuals must have a histological or a cytologically proven diagnosis of locally advanced, unresectable, and/or metastatic cancer
  • Individuals must have disease with evidence of KRAS G12C mutation in tumor tissue or circulating tumor DNA as determined by molecular testing
  • Individuals must be appropriate candidates for study treatment, after progressing on, being intolerant to, or ineligible for immunotherapy and platinum-based therapy.  Progressing on, being intolerant to, or ineligible for immunotherapy is NOT applicable to individuals in Cohort B4
  • Phase 1b Dose Expansion Part C (CRC):  Individuals must be appropriate candidates for study treatment and must have received at least one prior oxaliplatin- or irinotecan-containing regimen for advanced or metastatic CRC
  • Individuals must have an ECOG performance status of 0 or 1
  • Individuals must be able to swallow capsule/tablet
  • Additional eligibility in protocol.

Ineligibility Information

  • Pregnancy/breastfeeding
  • Individuals must not have a known targetable oncogenic driver mutation or alteration in genes such as EGFR, ALK, BRAF (V600E), MET (exon 14), ROS1, RET, or NTRK1/2/3
  • Individual has an active fungal, bacterial, and/or active untreated viral infection, including HIV or viral (A, B, or C) hepatitis (screening is not required unless mandated by local health authority)
  • Individual has a serious pre-existing medical condition(s) that, in the judgment of the Investigator, would preclude participation in this study, including ILD or severe dyspnea at rest and uncontrolled disease-related pericardial effusion or pleural effusion
  • Individual has a second active primary malignancy or has 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
  • Untreated active CNS metastases and/or carcinomatous meningitis
  • Individual has received prior treatment with any KRAS G12C small molecule inhibitor, except in the following scenarios where such prior therapy is allowed:
    • a) Phase 1a dose escalation backfill cohort (NSCLC only)
    • b) Cohort E1
    • c) Cohort B4
  • Additional ineligibility in protocol.