Tests Sofe-M in adults with selected advanced solid tumors
Tests whether Sofe-M is safe and tolerable in adults with advanced solid tumors.
Plain-language title generated from the registry record
Registry title: A Study of Sofe-M in Participants With Selected Advanced Solid Tumors
Key facts
- Where
- Atlanta, Columbus, Falls Church, Grand Rapids, Houston, La Jolla, Mineola, New York, Scottsdale, and West Valley City, United StatesSee the 11 sites
- Phase
- Phase 1
Where in United States
- Emory UniversityAtlanta, United StatesTaking people
- The Ohio State University (OSU) Wexner Medical CenterColumbus, United StatesTaking people
- Inova Schar Cancer InstituteFalls Church, United StatesNot yet recruiting
- South Texas Accelerated Research Therapeutics (START) MidwestGrand Rapids, United StatesTaking people
- The University of Texas MD Anderson Cancer CenterHouston, United StatesTaking people
- University of California, San Diego (UCSD) - Moores Cancer CenterLa Jolla, United StatesTaking people
- NYU Langone Health- Long IslandMineola, United StatesTaking people
- David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer CenterNew York, United StatesTaking people
- New York University (NYU) Clinical Cancer CenterNew York, United StatesTaking people
- HonorHealthScottsdale, United StatesTaking people
- START Mountain RegionWest Valley City, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Eli Lilly and Company
- Trial code
- NCT06400472EU 2024-511238-11-00
- Record updated
- 4 November 2026
- Original description
The purpose of this study is to find out whether the study drug, Sofetabart Mipitecan (LY4170156), is safe, tolerable and effective in participants with advanced solid tumors. The study is conducted in three parts - phase Ia (dose-escalation, dose-optimization), phase Ib (dose-expansion), and phase 2 (dose expansion). The study will last up to approximately 5 years.Read full original descriptionShow less
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
The purpose of this study is to find out whether the study drug, Sofetabart Mipitecan (LY4170156), is safe, tolerable and effective in participants with advanced solid tumors. The study is conducted in three parts - phase Ia (dose-escalation, dose-optimization), phase Ib (dose-expansion), and phase 2 (dose expansion). The study will last up to approximately 5 years.
Inclusion: 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: Any serious unresolved toxicities from prior therapy; 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; Significant cardiovascular disease; History of pneumonitis/interstitial lung disease; Prolongation of QT interval corrected for heart rate using Fridericia's formula (QTcF) ≥ 470 milliseconds (ms); Individual with known or suspected uncontrolled central nervous system (CNS) metastases; Individuals who are pregnant, breastfeeding or plan to breastfeed during study or within 30 days of last dose of study intervention.