A Study of LY3962673 in Participants With KRAS G12D-Mutant Solid Tumors

Lilly

Status and phase: Enrolling; Phase 1

Conditions: Non-small Cell Lung Cancer; Pancreatic Ductal Adenocarcinoma; Colorectal Cancer

Treatments: Drug: nab-paclitaxel; Drug: Oxaliplatin; Drug: Irinotecan; Drug: leucovorin; Drug: LY3962673; Drug: Cetuximab; Drug: 5-fluorouracil; Drug: Gemcitabine

Study type: Interventional

Funder types: Industry

Identifiers

NCT06586515

27189

J5J-OX-JZZA (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 530 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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530 participants in 2 patient groups

Phase 1a: LY3962673 Dose Escalation

Experimental group

Description:

Escalating doses of LY3962673 administered orally.

Treatment:

Drug: LY3962673

Phase 1b: LY3962673 Dose Expansion

Experimental group

Description:

LY3962673 administered orally either alone or in combination with other chemotherapy agents.

Treatment:

Drug: 5-fluorouracil

Drug: Gemcitabine

Drug: Cetuximab

Drug: leucovorin

Drug: LY3962673

Drug: Irinotecan

Drug: Oxaliplatin

Drug: nab-paclitaxel