A Study of Sofe-M 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.
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
Plus 3 other study approaches.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Sep 4, 2026 · Source: ClinicalTrials.gov
The study is currently accepting participants.
Interventional
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1
- Sponsor
- Eli Lilly and Company
- Interventions being studied
- Drug: Sofe-M; Drug: bevacizumab; Drug: carboplatin; Drug: Itraconazole; Drug: pembrolizumab
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
- 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
- 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
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- HonorHealthScottsdale, Arizona
- University of California, San Diego (UCSD) - Moores Cancer CenterLa Jolla, California
- Emory UniversityAtlanta, Georgia
- South Texas Accelerated Research Therapeutics (START) MidwestGrand Rapids, Michigan
- NYU Langone Health - Long IslandMineola, New York
- New York University (NYU) Clinical Cancer CenterNew York, New York
- David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer CenterNew York, New York
- The Ohio State University (OSU) Wexner Medical CenterColumbus, Ohio
- The University of Texas - MD Anderson Cancer CenterHouston, Texas
- START Mountain RegionWest Valley City, Utah
- Cancer Research SAAdelaide
- Icon Cancer Centre South BrisbaneQLD
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Sep 4, 2026. Always confirm current availability with the study team.