A Study of Sofe-M in Participants With Selected Advanced Solid Tumors

RecruitingPhase 1

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

Who can join

Ages 18 and older · All sexes

Full eligibility 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

About the 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.

What is being tested

Sofe-M (drug)
bevacizumab (drug)
carboplatin (drug)
Itraconazole (drug)
pembrolizumab (drug)

Sponsor: Eli Lilly and Company · Participants: 575 · Started: May 20, 2024

Contact the study team

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or · Phone: 1-317-615-4559

Official record on ClinicalTrials.gov — NCT06400472

Locations in the U.S.

Arizona	HonorHealth, Scottsdale
California	University of California, San Diego (UCSD) - Moores Cancer Center, La Jolla
Georgia	Emory University, Atlanta (Not yet recruiting)
Michigan	South Texas Accelerated Research Therapeutics (START) Midwest, Grand Rapids
New York	NYU Langone Health - Long Island, Mineola David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center, New York New York University (NYU) Clinical Cancer Center, New York
Ohio	The Ohio State University (OSU) Wexner Medical Center, Columbus
Texas	The University of Texas - MD Anderson Cancer Center, Houston
Utah	START Mountain Region, West Valley City

Conditions

From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.