Evaluating LY4170156 for advanced solid tumors
Official title: A First-in-Human, Phase 1/2 Trial to Assess the Safety, Tolerability and Preliminary Efficacy of Sofetabart Mipitecan (LY4170156), an Antibody-Drug Conjugate Targeting Folate Receptor α-Expressing Tumor Cells, in Participants With Selected Advanced Solid Tumors
Run by Eli Lilly and Company · NCT06400472 · Data updated 2026-11-12
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 | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 575 (estimated) |
| Sponsor | Eli Lilly and Company Industry-sponsored |
| Locations | 25 sites (Scottsdale, Arizona and 24 other locations) |
| Status | Recruiting |
| Started | May 20, 2024 |
| Main results expected | June 2029 |
| Study ends | June 2029 |
| Registry record updated | November 4, 2026 |
| Trial ID | NCT06400472 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include individuals with advanced ovarian, endometrial, cervical, non-small cell lung, or triple-negative breast cancers.
✕Probably not a fit
Patients with uncontrolled central nervous system metastases or significant cardiovascular disease may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: Other studies have shown promise with similar approaches targeting advanced solid tumors, indicating potential for success.
Who can join: the full rules
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, TNBC, and high grade endometrioid 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
Where it's running
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HonorHealth
Scottsdale, Arizona, United States Recruiting -
University of California, San Diego (UCSD) - Moores Cancer Center
La Jolla, California, United States Recruiting -
Emory University
Atlanta, Georgia, 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
Show 19 more locations
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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 -
Humanitas San Pio X
Milan, Italy Recruiting -
Istituto Europeo di Oncologia
Milan, 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 -
Inova Schar Cancer Institute
Falls Church, Virginia, United States Not yet 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
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Evaluating NKT3964 for Adults with Advanced Solid Tumors
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.