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

Eli Lilly and Company

Summary

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.

Eligibility

Age range: 18+ years
Sex: All
Healthy volunteers: No

Detailed 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 k…

Interventions

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

Locations (24)

HonorHealth
Scottsdale, Arizona
University of California, San Diego (UCSD) - Moores Cancer Center
La Jolla, California
Emory University
Atlanta, Georgia
South Texas Accelerated Research Therapeutics (START) Midwest
Grand Rapids, Michigan
NYU Langone Health - Long Island
Mineola, New York
New York University (NYU) Clinical Cancer Center
New York, New York