Evaluating LY3962673 for KRAS G12D-Mutant Solid Tumors

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

Phase 1 Interventional Eli Lilly and Company · NCT06586515

This study is testing a new treatment called LY3962673 to see if it can help people with advanced solid tumors that have a specific KRAS G12D mutation.

Quick facts

PhasePhase 1
Study typeInterventional
Enrollment630 (estimated)
Ages18 Years and up
SexAll
SponsorEli Lilly and Company Industry-sponsored
Drugs / interventionschemotherapy
Locations52 sites (Duarte, California and 51 other locations)
Trial IDNCT06586515 on ClinicalTrials.gov

What this trial studies

This study aims to assess the safety, tolerability, and antitumor activity of LY3962673, both as a standalone treatment and in combination with other chemotherapy agents, for patients with advanced solid tumors harboring the KRAS G12D mutation. Participants will be monitored for their response to the treatment over a period of approximately five years. The study includes various solid tumor types, such as pancreatic ductal adenocarcinoma, non-small cell lung cancer, and colorectal cancer.

Who should consider this trial

Good fit: Ideal candidates are individuals with advanced solid tumors that have a confirmed KRAS G12D mutation and have previously received systemic chemotherapy.

Not a fit: Patients with active CNS metastases or significant unresolved toxicities from prior therapies may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with KRAS G12D-mutant solid tumors, which are often difficult to treat.

How similar studies have performed: Other studies targeting KRAS mutations have shown promise, indicating potential for success with this novel approach.

Eligibility criteria

Show full inclusion / exclusion criteria
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.

Where this trial is running

Duarte, California and 51 other locations

+2 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions Pancreatic Ductal AdenocarcinomaNon-small Cell Lung CancerColorectal CancerKRAS G12DKRASLY3962673Cetuximabnab-paclitaxel
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.