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Back|NCT06586515Recruiting
Official Title

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

Phase
Phase 1
Sponsor
Eli Lilly and Company
Enrollment
630
Timeline
Sep 2024 → Mar 2029
About This Study

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.

Eligibility Criteria

Inclusion Criteria

  • 1Have 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.
  • 2Have evidence of KRAS G12D mutation in tumor tissue or circulating tumor DNA
  • 3Have an ECOG performance status of ≤ 1
  • 4Must have received ≥ 1 prior line of systemic chemotherapy for advanced or metastatic disease
  • 5Participants with asymptomatic or treated CNS disease may be eligible.

Exclusion Criteria

  • 1Have known active CNS metastases and/or carcinomatous meningitis.
  • 2Have any unresolved toxicities from prior therapy greater than National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 Grade 1.
  • 3Have significant cardiovascular disease as unstable angina or acute coronary syndrome, history of myocardial infarction, known reduced left ventricular ejection fraction.
  • 4Have active uncontrolled systemic bacterial, viral, fungal, or parasitic infection.
  • 5Have known active hepatitis B virus (HBV) and hepatitis C virus (HCV).
  • 6Have other active malignancy unless in remission with life expectancy greater than (\>) 2 years.

Locations

52 sites participating in this study

Emory University School of Medicine

Atlanta, Georgia 30322

Recruiting

City of Hope

Duarte, California 91010

Recruiting

University of California, Los Angeles (UCLA)

Los Angeles, California 90025

Recruiting
Data sourced from ClinicalTrials.govView on ClinicalTrials.gov →