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Trial Title:
A Study of the Pan-KRAS Inhibitor LY4066434 in Participants With KRAS Mutant Solid Tumors
NCT ID:
NCT06607185
Condition:
Pancreatic Ductal Adenocarcinoma
Non-small Cell Lung Cancer
Colorectal Cancer
Advanced Solid Tumor
Metastatic Solid Tumor
Conditions: Official terms:
Neoplasms
Colorectal Neoplasms
Leucovorin
Carboplatin
Gemcitabine
Pembrolizumab
Oxaliplatin
Fluorouracil
Irinotecan
Pemetrexed
Cetuximab
Conditions: Keywords:
KRAS
KRAS mutation
KRASG12C
KRASG12D
KRASG12V
KRASG12S
KRASG12A
KRASG13D
LY4066434
Targeted therapy
Lung cancer
Pancreas cancer
Colon cancer
Rectal cancer
Colorectal cancer
Ovarian cancer
Endometrial cancer
Cholangiocarcinoma
Esophageal cancer
KRAS-mutant tumor
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
LY4066434.
Description:
Administered orally.
Arm group label:
LY4066434 Dose Optimization
Arm group label:
LY4066434 Monotherapy Dose Escalation
Intervention type:
Drug
Intervention name:
Cetuximab
Description:
Administered intravenously.
Arm group label:
LY4066434 Dose Optimization
Intervention type:
Drug
Intervention name:
Nab paclitaxel
Description:
Administered intravenously.
Arm group label:
LY4066434 Dose Optimization
Intervention type:
Drug
Intervention name:
Gemcitabine
Description:
Administered intravenously.
Arm group label:
LY4066434 Dose Optimization
Intervention type:
Drug
Intervention name:
Oxaliplatin
Description:
Administered intravenously.
Arm group label:
LY4066434 Dose Optimization
Intervention type:
Drug
Intervention name:
Leucovorin
Description:
Administered intravenously.
Arm group label:
LY4066434 Dose Optimization
Intervention type:
Drug
Intervention name:
Irinotecan
Description:
Administered intravenously.
Arm group label:
LY4066434 Dose Optimization
Intervention type:
Drug
Intervention name:
5Fluorouracil
Description:
Administered intravenously.
Arm group label:
LY4066434 Dose Optimization
Intervention type:
Drug
Intervention name:
Carboplatin
Description:
Administered intravenously.
Arm group label:
LY4066434 Dose Optimization
Intervention type:
Drug
Intervention name:
Cisplatin
Description:
Administered intravenously.
Arm group label:
LY4066434 Dose Optimization
Intervention type:
Drug
Intervention name:
Pemetrexed
Description:
Administered intravenously.
Arm group label:
LY4066434 Dose Optimization
Intervention type:
Drug
Intervention name:
Pembrolizumab
Description:
Administered intravenously.
Arm group label:
LY4066434 Dose Optimization
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.
Criteria for eligibility:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
START Midwest
Address:
City:
Grand Rapids
Zip:
49546
Country:
United States
Status:
Recruiting
Facility:
Name:
South Texas Accelerated Research Therapeutics (START
Address:
City:
San Antonio
Zip:
78229-3307
Country:
United States
Status:
Recruiting
Start date:
October 21, 2024
Completion date:
January 2030
Lead sponsor:
Agency:
Eli Lilly and Company
Agency class:
Industry
Source:
Eli Lilly and Company
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06607185
http://trials.lilly.com/en-US/trial/533775
