Recruiting

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.

ClinicalTrials.gov IDNCT06400472

PhasePHASE1

Enrollment575

SponsorEli Lilly and Company

Age18 Years

SexALL

I'm interested View official listing

Conditions studied

Ovarian Neoplasms, Endometrial Neoplasms, Uterine Cervical Neoplasms, Carcinoma, Non-Small-Cell Lung, Triple Negative Breast Neoplasms, Pancreatic Neoplasm, Colorectal Neoplasms

About this study

Interventions

Drug: Sofe-M — Intravenous
Drug: bevacizumab — IV
Drug: carboplatin — IV
Drug: Itraconazole — oral
Drug: pembrolizumab — IV

Primary outcomes

Phase 1a: To determine the recommended phase 2 dose (RP2D) of Sofe-M (LY4170156) (1 Cycle (21 or 28 days))
Phase 1a: To determine the RP2D or optimal dose of Sofe-M (LY4170156) with bevacizumab (1 Cycle (21 or 28 days))
Phase 1a: To determine the RP2D or optimal dose of Sofe-M (LY4170156) with carboplatin (1 Cycle (21 or 28 days))
Phase 1a: To determine the RP2D or optimal dose of Sofe-M (LY4170156) with pembrolizumab (1 Cycle (21 or 28 days))
Phase 1b: To assess the antitumor activity of Sofe-M (LY4170156) Monotherapy: Overall response rate (ORR) (Up to Approximately 60 Months or 5 Years)
Phase 2: To assess the antitumor activity of Sofe-M (LY4170156) Monotherapy: ORR (Up to Approximately 60 Months or 5 Years)
Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration (Up to Approximately 60 Months or 5 Years)

Eligibility information

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

Study locations

HonorHealth, Scottsdale, Arizona 85258 United States
University of California, San Diego (UCSD) - Moores Cancer Center, La Jolla, California 92037 United States
Emory University, Atlanta, Georgia 30308 United States
South Texas Accelerated Research Therapeutics (START) Midwest, Grand Rapids, Michigan 49546 United States
NYU Langone Health - Long Island, Mineola, New York 11501 United States
New York University (NYU) Clinical Cancer Center, New York, New York 10016 United States
David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center, New York, New York 10065 United States
The Ohio State University (OSU) Wexner Medical Center, Columbus, Ohio 43210 United States
The University of Texas - MD Anderson Cancer Center, Houston, Texas 77030-4000 United States
START Mountain Region, West Valley City, Utah 84119 United States

Showing 10 of 24 reported sites. See the official listing for all locations.

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.