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โ† Trials
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A Study of Sofe-M in Participants With Selected Advanced Solid Tumors

RecruitingPhase 1Ages 18 Years - anyAllEli Lilly and Company
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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) โ‰ฅ 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
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What it tests

  • Sofe-M
  • bevacizumab
  • carboplatin
  • Itraconazole
  • pembrolizumab
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Where

25 sites
HonorHealth
Scottsdale, United States
University of California, San Diego (UCSD) - Moores Cancer Center
La Jolla, United States
Emory University
Atlanta, United States
South Texas Accelerated Research Therapeutics (START) Midwest
Grand Rapids, United States
NYU Langone Health - Long Island
Mineola, United States
New York University (NYU) Clinical Cancer Center
New York, United States
David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center
New York, United States
The Ohio State University (OSU) Wexner Medical Center
Columbus, United States

โ€ฆand 17 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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