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RECRUITING Phase 1 ClinicalTrials.gov

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

Sponsor: Eli Lilly and Company • ClinicalTrials.gov ID: NCT06400472

Registry updated: 2026-10-07
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Description

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.

Interventions

  • Sofe-M (Drug)
    Intravenous
  • bevacizumab (Drug)
    IV
  • carboplatin (Drug)
    IV
  • Itraconazole (Drug)
    oral
  • pembrolizumab (Drug)
    IV

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

Conditions

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

Locations

  • HonorHealth — Scottsdale, Arizona, United States
  • University of California, San Diego (UCSD) - Moores Cancer Center — La Jolla, California, United States
  • Emory University — Atlanta, Georgia, United States
  • South Texas Accelerated Research Therapeutics (START) Midwest — Grand Rapids, Michigan, United States
  • NYU Langone Health - Long Island — Mineola, New York, United States
  • New York University (NYU) Clinical Cancer Center — New York, New York, United States
  • David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center — New York, New York, United States
  • The Ohio State University (OSU) Wexner Medical Center — Columbus, Ohio, United States
  • The University of Texas - MD Anderson Cancer Center — Houston, Texas, United States
  • START Mountain Region — West Valley City, Utah, United States
  • Inova Schar Cancer Institute — Falls Church, Virginia, United States
  • Cancer Research SA — Adelaide, Australia
  • Icon Cancer Centre South Brisbane — QLD, Australia
  • Centre Leon Berard — Lyon, France
  • Institut de Cancerologie de l'Ouest - site St-Herblain — Saint-Herblain, France
  • Oncopole Claudius Regaud — Toulouse, France
  • Humanitas San Pio X — Milan, Italy
  • Istituto Europeo di Oncologia — Milan, Italy
  • Shizuoka Cancer Center — Shizuoka, Japan
  • National Cancer Center Hospital — Tokyo, Japan
  • Cancer Institute Hospital of JFCR — Tokyo, Japan
  • National Cancer Center — Goyang-si Gyeonggi-do, South Korea
  • Hospital Universitario Vall d'Hebron — Barcelona, Spain
  • Hospital Universitario 12 de Octubre — Madrid, Spain
  • Hospital Clinico Universitario de Valencia — Valencia, Spain
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record