RecruitingOvarian NeoplasmsEndometrial NeoplasmsUterine Cervical Neoplasms
A Study of Sofe-M in Participants With Selected Advanced Solid Tumors
Eligible age
18+ yrs
Accepts
All genders
Locations
8 states
Healthy volunteers
No
See if you qualify for this study
Answer a few quick questions about your location and health. Takes about a minute.
About this study
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.
Sponsor: Eli Lilly and Company
You may qualify if…
- ✓ 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
You may not qualify if…
- ✕ 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
Where it's recruiting
Source: ClinicalTrials.gov · NCT06400472 · last updated 2026-09-04