Evaluating LY4170156 for advanced solid tumors
A First-in-Human, Phase 1a/1b Trial to Assess the Safety, Tolerability and Preliminary Efficacy of LY4170156, an Antibody-Drug Conjugate Targeting Folate Receptor α-Expressing Tumor Cells, in Participants With Selected Advanced Solid Tumors
PHASE1 · Eli Lilly and Company · NCT06400472
This study is testing a new drug called LY4170156 to see if it is safe and effective for people with advanced solid tumors like ovarian and lung cancers.
Quick facts
| Phase | PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 495 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Eli Lilly and Company (industry) |
| Locations | 23 sites (Scottsdale, Arizona and 22 other locations) |
| Trial ID | NCT06400472 on ClinicalTrials.gov |
What this trial studies
This study investigates the safety, tolerability, and effectiveness of the drug LY4170156 in patients with selected advanced solid tumors. It is structured in two parts: a phase Ia for dose-escalation and optimization, followed by a phase Ib for dose-expansion. The trial aims to enroll participants with various types of cancers, including ovarian, endometrial, cervical, non-small cell lung, and triple-negative breast cancers. The study is expected to last approximately four years.
Who should consider this trial
Good fit: Ideal candidates include individuals with advanced ovarian, endometrial, cervical, non-small cell lung, or triple-negative breast cancers.
Not a fit: Patients with uncontrolled central nervous system metastases or significant cardiovascular disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option for patients with advanced solid tumors.
How similar studies have performed: Other studies have shown promise with similar approaches targeting advanced solid tumors, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Scottsdale, Arizona and 22 other locations
- HonorHealth — Scottsdale, Arizona, United States (RECRUITING)
- University of California, San Diego (UCSD) - Moores Cancer Center — La Jolla, California, United States (RECRUITING)
- South Texas Accelerated Research Therapeutics (START) Midwest — Grand Rapids, Michigan, United States (RECRUITING)
- NYU Langone Health - Long Island — Mineola, New York, United States (RECRUITING)
- New York University (NYU) Clinical Cancer Center — New York, New York, United States (RECRUITING)
- David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center — New York, New York, United States (RECRUITING)
- The Ohio State University (OSU) Wexner Medical Center — Columbus, Ohio, United States (RECRUITING)
- The University of Texas - MD Anderson Cancer Center — Houston, Texas, United States (RECRUITING)
- START Mountain Region — West Valley City, Utah, United States (RECRUITING)
- Cancer Research SA — Adelaide, Australia (RECRUITING)
- Icon Cancer Centre South Brisbane — QLD, Australia (RECRUITING)
- Centre Leon Berard — Lyon, France (RECRUITING)
- Institut de Cancerologie de l'Ouest - site St-Herblain — Saint-Herblain, France (RECRUITING)
- Oncopole Claudius Regaud — Toulouse, France (RECRUITING)
- Istituto Europeo di Oncologia — Milan, Italy (RECRUITING)
- Istituto Clinico Humanitas — Rozzano, Italy (RECRUITING)
- Shizuoka Cancer Center — Shizuoka, Japan (RECRUITING)
- National Cancer Center Hospital — Tokyo, Japan (RECRUITING)
- Cancer Institute Hospital of JFCR — Tokyo, Japan (RECRUITING)
- National Cancer Center — Goyang-si Gyeonggi-do, South Korea (RECRUITING)
- Hospital Universitario Vall d'Hebron — Barcelona, Spain (RECRUITING)
- Hospital Universitario 12 de Octubre — Madrid, Spain (RECRUITING)
- Hospital Clinico Universitario de Valencia — Valencia, Spain (RECRUITING)
Study contacts
- Study coordinator: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
- Email: LillyTrials@Lilly.com
- Phone: 1-317-615-4559
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Ovarian Neoplasms, Endometrial Neoplasms, Uterine Cervical Neoplasms, Carcinoma, Non-Small-Cell Lung, Triple Negative Breast Neoplasms, Pancreatic Neoplasm, Colorectal Neoplasms, Folate receptor alpha