RecruitingPhase 1NCT06400472

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

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

Sponsor

Eli Lilly and Company

Enrollment

575 participants

Start Date

May 20, 2024

Study Type

INTERVENTIONAL

Conditions

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

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new cancer drug called LY4170156 in people with advanced solid tumors including ovarian, cervical, endometrial, lung, triple-negative breast, pancreatic, and colorectal cancers. The trial is in early phases to find the right dose and see how safe the drug is. **You may be eligible if...** - You are 18 or older - You have one of several specified advanced solid tumors that have not responded to standard treatment - Your overall health and organ function are within acceptable ranges **You may NOT be eligible if...** - You have uncontrolled cancer that has spread to the brain - You have a history of corneal transplant or significant corneal eye disease - You have active uncontrolled infections - You have significant heart disease or a prolonged QT interval (an abnormal heart rhythm finding) - You have a history of lung inflammation (pneumonitis or interstitial lung disease) - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSofe-M

Intravenous

DRUGbevacizumab

DRUGcarboplatin

DRUGItraconazole

oral

DRUGpembrolizumab

Locations(24)

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

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

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06400472

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