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Trial Title:
A Study of LY3962673 in Participants With KRAS G12D-Mutant Solid Tumors
NCT ID:
NCT06586515
Condition:
Pancreatic Ductal Adenocarcinoma
Non-small Cell Lung Cancer
Colorectal Cancer
Conditions: Official terms:
Adenocarcinoma
Leucovorin
Paclitaxel
Gemcitabine
Oxaliplatin
Fluorouracil
Irinotecan
Cetuximab
Conditions: Keywords:
KRAS G12D
KRAS
LY3962673
Cetuximab
nab-paclitaxel
Gemcitabine
Oxaliplatin
Leucovorin
Irinotecan
5-fluorouracil
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
LY3962673
Description:
Administered orally.
Arm group label:
Phase 1a: LY3962673 Dose Escalation
Arm group label:
Phase 1b: LY3962673 Dose Expansion
Intervention type:
Drug
Intervention name:
Cetuximab
Description:
Administered intravenously.
Arm group label:
Phase 1b: LY3962673 Dose Expansion
Intervention type:
Drug
Intervention name:
Gemcitabine
Description:
Administered intravenously.
Arm group label:
Phase 1b: LY3962673 Dose Expansion
Intervention type:
Drug
Intervention name:
nab-paclitaxel
Description:
Administered intravenously.
Arm group label:
Phase 1b: LY3962673 Dose Expansion
Intervention type:
Drug
Intervention name:
Oxaliplatin
Description:
Administered intravenously.
Arm group label:
Phase 1b: LY3962673 Dose Expansion
Intervention type:
Drug
Intervention name:
leucovorin
Description:
Administered intravenously.
Arm group label:
Phase 1b: LY3962673 Dose Expansion
Intervention type:
Drug
Intervention name:
Irinotecan
Description:
Administered intravenously.
Arm group label:
Phase 1b: LY3962673 Dose Expansion
Intervention type:
Drug
Intervention name:
5-fluorouracil
Description:
Administered intravenously.
Arm group label:
Phase 1b: LY3962673 Dose Expansion
Summary:
The main purpose of this study is to assess safety & tolerability and antitumor activity
of LY3962673 as monotherapy and in combination with other chemotherapy agents in
participants with KRAS G12D-mutant advanced solid tumor types. The study is expected to
last approximately 5 years.
Criteria for eligibility:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Florida Cancer Specialists Lake Nona Drug Development Unit
Address:
City:
Orlando
Zip:
32827
Country:
United States
Status:
Recruiting
Facility:
Name:
START Midwest
Address:
City:
Grand Rapids
Zip:
49546
Country:
United States
Status:
Recruiting
Facility:
Name:
NYU Langone
Address:
City:
New York
Zip:
10016
Country:
United States
Status:
Recruiting
Facility:
Name:
Sarah Cannon Cancer Center
Address:
City:
Nashville
Zip:
37203
Country:
United States
Status:
Recruiting
Facility:
Name:
START San Antonio
Address:
City:
San Antonio
Zip:
78229
Country:
United States
Status:
Recruiting
Start date:
September 12, 2024
Completion date:
March 2029
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/NCT06586515
https://trials.lilly.com/en-US/trial/533076
