A Study of LY4170156 in Participants With Selected Advanced Solid Tumors
Recruiting · NCT06400472 · Interventional (participants receive a specific treatment) · Lead sponsor: Eli Lilly and Company
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Have one of the following solid tumor cancers:
- Dose Escalation: 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 cancer, or colorectal cancer (CRC)
- Dose Optimization: Ovarian (epithelial ovarian, primary peritoneal, and fallopian tube) and endometrial cancer
- Dose Expansion: Low grade serous ovarian cancer, cervical cancer, NSCLC, and TNBC
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
Where it is running
23 locations listed across 7 US states.
- HonorHealth - Scottsdale, Arizona, United States
- University of California, San Diego (UCSD) - Moores Cancer Center - La Jolla, California, United States
- South Texas Accelerated Research Therapeutics (START) Midwest - Grand Rapids, Michigan, United States
- NYU Langone Health - Long Island - Mineola, New York, United States
- New York University (NYU) Clinical Cancer Center - New York, New York, United States
- David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center - New York, New York, United States
- The Ohio State University (OSU) Wexner Medical Center - Columbus, Ohio, United States
- The University of Texas - MD Anderson Cancer Center - Houston, Texas, United States
- START Mountain Region - West Valley City, Utah, United States
- Cancer Research SA - Adelaide, Australia
- Hospital Universitario Vall d'Hebron - Barcelona, Spain
- National Cancer Center - Goyang-si Gyeonggi-do, South Korea
- Centre Leon Berard - Lyon, France
- Hospital Universitario 12 de Octubre - Madrid, Spain
- Humanitas San Pio X - Milan, Italy
- Istituto Europeo di Oncologia - Milan, Italy
- Icon Cancer Centre South Brisbane - QLD, Australia
- Institut de Cancerologie de l'Ouest - site St-Herblain - Saint-Herblain, France
- Shizuoka Cancer Center - Shizuoka, Japan
- National Cancer Center Hospital - Tokyo, Japan
- Cancer Institute Hospital of JFCR - Tokyo, Japan
- Oncopole Claudius Regaud - Toulouse, France
- Hospital Clinico Universitario de Valencia - Valencia, Spain