Trial Title:
A Study of LY4170156 in Participants With Selected Advanced Solid Tumors
NCT ID:
NCT06400472
Condition:
Ovarian Neoplasms
Endometrial Neoplasms
Uterine Cervical Neoplasms
Carcinoma, Non-Small-Cell Lung
Triple Negative Breast Neoplasms
Pancreatic Neoplasm
Colorectal Neoplasms
Conditions: Official terms:
Neoplasms
Breast Neoplasms
Colorectal Neoplasms
Carcinoma, Non-Small-Cell Lung
Pancreatic Neoplasms
Ovarian Neoplasms
Uterine Cervical Neoplasms
Endometrial Neoplasms
Triple Negative Breast Neoplasms
Conditions: Keywords:
Folate receptor alpha
NSCLC
Ovarian cancer
Cervical cancer
Endometrial cancer
Solid tumor
Lung cancer
Breast cancer
Pancreatic cancer
Colorectal cancer
Anti-drug conjugate
Phase I
Chemotherapy
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
LY4170156
Description:
Intravenous
Arm group label:
LY4170156 (Dose-escalation, Cohort A1)
Arm group label:
LY4170156 (Dose-expansion, Cohort B1, B2, C1, C2)
Arm group label:
LY4170156 (Dose-optimization, Cohort A2)
Summary:
The purpose of this study is to find out whether the study drug, LY4170156, is safe,
tolerable and effective in participants with advanced solid tumors. The study is
conducted in two parts - phase Ia (dose-escalation, dose-optimization) and phase Ib
(dose-expansion). The study will last up to approximately 4 years.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Have one of the following solid tumor cancers:
- Cohort A1: Ovarian (epithelial ovarian, primary peritoneal, and fallopian tube)
cancer, endometrial cancer, cervical cancer, non-small cell lung cancer
(NSCLC), triple-negative breast cancer (TNBC), pancreatic, and colorectal
cancer (CRC)
- Cohort A2/B1/B2: Ovarian (epithelial ovarian, primary peritoneal, and fallopian
tube) cancer
- Cohort C1/C2: Endometrial cancer, cervical cancer, NSCLC, TNBC, CRC or
pancreatic cancer
Exclusion Criteria:
- Individual with known or suspected uncontrolled central nervous system (CNS)
metastases
- Individual with history of carcinomatous meningitis
- Individual with active uncontrolled systemic bacterial, viral, fungal, or parasitic
infection
- Individual with evidence of corneal keratopathy or history of corneal transplant
- Any serious unresolved toxicities from prior therapy
- Significant cardiovascular disease
- Prolongation of QT interval corrected for heart rate using Fridericia's formula
(QTcF) ≥ 470 milliseconds (ms)
- History of pneumonitis/interstitial lung disease
- Individuals who are pregnant, breastfeeding or plan to breastfeed during study or
within 30 days of last dose of study intervention
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Honor Health Research Institute
Address:
City:
Scottsdale
Zip:
85258
Country:
United States
Status:
Recruiting
Facility:
Name:
South Texas Accelerated Research Therapeutics (START)
Address:
City:
Grand Rapids
Zip:
49546
Country:
United States
Status:
Recruiting
Facility:
Name:
NYU Langone Health
Address:
City:
New York
Zip:
10016
Country:
United States
Status:
Recruiting
Facility:
Name:
Memorial Sloan Kettering Cancer Center
Address:
City:
New York
Zip:
10065
Country:
United States
Status:
Recruiting
Facility:
Name:
Ohio State University Medical Center
Address:
City:
Columbus
Zip:
43210
Country:
United States
Status:
Recruiting
Facility:
Name:
START Mountain Region
Address:
City:
West Valley City
Zip:
84119
Country:
United States
Status:
Recruiting
Facility:
Name:
Cancer Research SA
Address:
City:
Adelaide
Zip:
5000
Country:
Australia
Status:
Recruiting
Facility:
Name:
Centre Leon Berard
Address:
City:
Lyon
Zip:
69373
Country:
France
Status:
Recruiting
Facility:
Name:
Shizuoka Cancer Center
Address:
City:
Sunto-gun
Zip:
411-8777
Country:
Japan
Status:
Recruiting
Facility:
Name:
National Cancer Center Hospital
Address:
City:
Chuo Ku
Zip:
104-0045
Country:
Japan
Status:
Recruiting
Facility:
Name:
The Cancer Institute Hospital of JFCR
Address:
City:
Tokyo
Zip:
135-8550
Country:
Japan
Status:
Recruiting
Facility:
Name:
Hospital Universitario Vall d'Hebron
Address:
City:
Barcelona
Zip:
08035
Country:
Spain
Status:
Recruiting
Start date:
May 6, 2024
Completion date:
April 2027
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/NCT06400472
https://trials.lilly.com/en-US/trial/482318
