Phase 1a/1b Study of LY3962673 in Patients with KRAS G12D-Mutant Solid Tumors

Cancer Categories

Karmanos Trial ID

NCT ID

Age Group

Scope

Phase

Principal Investigator

Primary Objectives:

Phase 1a Primary

Phase 1a Secondary

Phase 1b Primary

Dose Expansion: To assess the antitumor activity of LY3962673
Dose Optimization: To confirm the RP2D/optimal dose based on safety and efficacy of LY3962673

Phase 1b Secondary

Dose Expansion: To assess the safety and tolerability of LY3962673
Dose Expansion: To assess, for each Dose Expansion cohort, the antitumor activity per RECIST v1.1
All Cohorts: To characterize the PK properties of LY3962673

Eligibility

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).

Locations

4100 John R
Detroit, MI 48201
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Phone: 1-800-527-6266

31995 Northwestern Hwy
Farmington Hills, MI 48334
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Phone: 1-800-527-6266

Applicable Disease Site

Therapies, Drugs, Devices