Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Santa Monica, California and other locations
Dates
study started
completion around
Principal Investigator
by Edward Garon

Description

Summary

The main purpose of the study is to assess whether the study drug, LY4066434, is safe and tolerable when administered to participants with locally advanced or metastatic solid tumors with certain KRAS mutations. LY4066434 will be given alone or in combination with other treatments. The study will have 2 parts: monotherapy dose escalation and dose optimization. The study is expected to last up to approximately 5 years.

Official Title

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

Keywords

Pancreatic Ductal Adenocarcinoma, Non-small Cell Lung Cancer, Colorectal Cancer, Advanced Solid Tumor, Metastatic Solid Tumor, KRAS, KRAS mutation, KRASG12C, KRASG12D, KRASG12V, KRASG12S, KRASG12A, KRASG13D, LY4066434, Targeted therapy, Lung cancer, Pancreas cancer, Colon cancer, Rectal cancer, Ovarian cancer, Endometrial cancer, Cholangiocarcinoma, Esophageal cancer, KRAS-mutant tumor, Neoplasms, Colorectal Neoplasms, Leucovorin, Carboplatin, Gemcitabine, Pembrolizumab, Oxaliplatin, Fluorouracil, Irinotecan, Pemetrexed, Cetuximab, Nab paclitaxel, 5Fluorouracil, Cisplatin

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

  • 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

Locations

  • UCLA not yet accepting patients
    Santa Monica California 90404 United States
  • City of Hope National Medical Center not yet accepting patients
    Duarte California 91010-0269 United States
  • South Texas Accelerated Research Therapeutics (START) accepting new patients
    San Antonio Texas 78229-3307 United States
  • START Midwest accepting new patients
    Grand Rapids Michigan 49546 United States

Lead Scientist at UCLA

  • Edward Garon
    Professor, Medicine. Authored (or co-authored) 203 research publications

Details

Status
accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
(estimated)
Sponsor
Eli Lilly and Company
Links
A Study of the Pan-KRAS Inhibitor LY4066434 in Participants With KRAS Mutant Solid Tumors
ID
NCT06607185
Phase
Phase 1 research study
Study Type
Interventional
Participants
Expecting 750 study participants
Last Updated