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Phase 1Recruiting

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

Sponsored by Eli Lilly and Company

About this 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.

Where this study is enrolling (3)

  • HonorHealth

    Scottsdale, Arizona

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  • Emory University

    Atlanta, Georgia

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  • The University of Texas - MD Anderson Cancer Center

    Houston, Texas

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Who can participate

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

Only the research team can confirm whether you qualify. The intake questionnaire is the best way to find out.

Completing a questionnaire on Clinably does not enroll you in a clinical trial or confirm your eligibility. Only the research team can determine whether you qualify to participate. These results are based on the information you provide and are intended to help you start a conversation with the research team.

Trial data sourced from ClinicalTrials.gov.