A Study of Sofe-M in Participants With Selected Advanced Solid Tumors
Recruiting · Phase 1 · NCT06400472
Conditions: Ovarian Neoplasms, Endometrial Neoplasms, Uterine Cervical Neoplasms, Carcinoma, Non-Small-Cell Lung, Triple Negative Breast Neoplasms, Pancreatic Neoplasm, Colorectal Neoplasms
At a glance
- Research payments reported, 2025
- $5.6M
- U.S. investigators named
- 9
- Sites paid
- 8
- Planned or actual enrollment
- 575
About the trial
- Sponsor
- Eli Lilly and Company
- Tested
- Sofe-M (drug), bevacizumab (drug), carboplatin (drug), Itraconazole (drug), pembrolizumab (drug)
- Dates
- Started 2024-05-20; completion 2029-06
- Results posted
- Not yet
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.
From ClinicalTrials.gov, last updated 2026-11-04. Full record, eligibility and contacts (opens in a new tab)
Industry funding
Eli Lilly and Company reported $5.6M in research payments for this study in 2025 (9 payments).
Research payments usually go to hospitals, universities and research sites to run a study, not to the investigators personally. A payment is not evidence of wrongdoing.
U.S. investigators named on this study
- Ramez N. Eskander, M.D Gynecologic Oncology · Encinitas, CA
- Muhammad R. Khawaja, MD, MPH Hematology & Oncology · Bel Air, MD
- Nehal J. Lakhani, M.D. Hematology & Oncology · Grand Rapids, MI
- Claire F. Friedman, MD Internal Medicine · New York, NY
- Chrisann Kyi, M.D. Medical Oncology · New York, NY
- Bhavana Pothuri, M.D. Gynecologic Oncology · New York, NY
- David M. O'malley, M.D. Gynecologic Oncology · Hilliard, OH
- Shannon N. Westin, MD OB-GYN (Obstetrics & Gynecology) · Houston, TX
- William B. Mckean JR., M.D., PH.D. Student in an Organized Health Care Education/Training Program · Salt Lake City, UT
Clinicians the company named as principal investigators in its Open Payments reports.
Sites paid to run it
- Memorial Sloan-Kettering $1.4M
- The Ohio State University $1.1M
- New York University $890,803
- Start Mountain Region LLC $778,077
- Start Ctr for Cancer Care $755,701
- Honor Health John C. Lincoln Medical Center, AZ $333,853
- Regents of the University of California $231,629
- Ut MD Anderson Cancer Center $99,285
Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.