A Study of the Pan-KRAS Inhibitor LY4066434 in Participants With KRAS Mutant Solid Tumors
a study on Pancreatic Ductal Adenocarcinoma Lung Cancer Non-Small Cell Lung Cancer Colorectal Cancer Solid Tumor Colorectal Tumor Lung Tumor Pancreatic Cancer Pancreatic Neoplasms Colon Cancer Rectal Cancer Ovarian Cancer Endometrial Cancer Cholangiocarcinoma Esophageal Cancer
Summary
- Eligibility
- for people ages 18 years and up (full criteria)
- Location
- at Los Angeles 5368361, California 5332921 and other locations
- Dates
- study startedstudy ends around
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, PanKRAS, Pan KRAS, Non-Small-Cell Lung Carcinoma, Colorectal Neoplasms, Neoplasm Metastasis, Lung Neoplasms, Pancreatic Neoplasms, Colonic Neoplasms, Rectal Neoplasms, Ovarian Neoplasms, Endometrial Neoplasms, Esophageal Neoplasms, Cetuximab, Taxes, Gemcitabine, Oxaliplatin, Leucovorin, Irinotecan, Fluorouracil, Carboplatin, Cisplatin, Pemetrexed, pembrolizumab, Nab paclitaxel, 5Fluorouracil
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, hearing loss, 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) or 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
- University of California, Los Angeles (UCLA)
accepting new patients
Los Angeles 5368361 California 5332921 90025 United States - City of Hope
accepting new patients
Duarte 5344147 California 5332921 91010 United States
Details
- Status
- accepting new patients
- Start Date
- Completion Date
- (estimated)
- Sponsor
- Eli Lilly and Company
- Links
- Sign up for this study
- ID
- NCT06607185
- Phase
- Phase 1 research study
- Study Type
- Interventional
- Participants
- Expecting 750 study participants
- Last Updated
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