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Testing a new drug for patients with certain KRAS mutant solid tumors

A Phase 1a/1b Study of the Pan-KRAS Inhibitor LY4066434 in Participants With KRAS Mutant Solid Tumors

PHASE1 · Eli Lilly and Company · NCT06607185

This study is testing a new drug called LY4066434 to see if it is safe and effective for people with advanced solid tumors that have specific KRAS mutations, either on its own or with other treatments.

Quick facts

PhasePHASE1
Study typeInterventional
Enrollment750 (estimated)
Ages18 Years and up
SexAll
SponsorEli Lilly and Company (industry)
Locations52 sites (Birmingham, Alabama and 51 other locations)
Trial IDNCT06607185 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and tolerability of the drug LY4066434 in patients with locally advanced or metastatic solid tumors that have specific KRAS mutations. Participants will receive LY4066434 either alone or in combination with other treatments such as cetuximab, nab paclitaxel, gemcitabine, or oxaliplatin. The study consists of two parts: a dose escalation phase and a dose optimization phase, and is expected to last up to five years.

Who should consider this trial

Good fit: Ideal candidates include individuals with locally advanced or metastatic solid tumors that have specific KRAS mutations and meet the study's inclusion criteria.

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 study could provide a new treatment option for patients with KRAS mutant solid tumors, potentially improving their outcomes.

How similar studies have performed: Other studies targeting KRAS mutations have shown promise, indicating that this approach may be effective.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Have evidence of KRAS G12C, G12D, G12V, G12A, G12S, or G13D mutation in tumor tissue or circulating tumor DNA
* Histological or cytologically proven diagnosis of a locally advanced, unresectable, and/or metastatic solid tumor cancer
* Have measurable disease per RECIST 1.1
* Have an ECOG performance status of ≤1
* Must not be pregnant and/or planning to breastfeed during the trial or within 180 days of the last dose of trial intervention
* Must be able to swallow tablets
* 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 NCI CTCAE Version 5.0 Grade 1 at the time of starting trial treatment, except for alopecia, peripheral neuropathy and ongoing endocrinopathies controlled on appropriate replacement therapy
* Have significant cardiovascular disease defined as unstable angina or acute coronary syndrome, history of myocardial infarction, known left ventricular ejection fraction or heart failure, uncontrolled or symptomatic arrhythmias.
* Have known active hepatitis B virus (HBV), hepatitis C virus (HCV) and untreated HIV infection
* Have other active malignancy unless in remission with life expectancy greater than 2 years.
* Have active uncontrolled systemic bacterial, viral, fungal, or parasitic infection
* Have history of non-infectious pneumonitis/interstitial lung disease that received steroids or has current clinically significant pneumonitis/interstitial lung disease

Where this trial is running

Birmingham, Alabama 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.

View on ClinicalTrials.gov →

Conditions: Pancreatic Ductal Adenocarcinoma, Non-small Cell Lung Cancer, Colorectal Cancer, Advanced Solid Tumor, Metastatic Solid Tumor, KRAS, KRAS mutation, KRASG12C

Last reviewed 2026-05-15 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.