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A Study of Sofe-M in Participants With Selected Advanced Solid Tumors
Trial Status: active
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.
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 sponsor and potential other locations can be found on ClinicalTrials.gov for NCT06400472.
Locations matching your search criteria
United States
California
La Jolla
UC San Diego Moores Cancer Center
Status: Active
Name Not Available
New York
New York
Laura and Isaac Perlmutter Cancer Center at NYU Langone
