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:
2.02452E+11
EU Trial (CTIS) Number:
2024-516440-25-00
Study Contact Information:
(210) 593-5651 or [email protected]
Recruiting

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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.
Phase 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 Carolinas
Myrtle Beach, SC, United States, 29572
Investigator
Status
Recruitment Complete
Condition(s) Treated at Site
Pancreas
Non-Small Cell Lung Cancer
Bowel (Colorectal)