RecruitingPhase 1Phase 2NCT05919264

FOG-001 in Locally Advanced or Metastatic Solid Tumors

A Phase 1/2 Study of FOG-001 in Participants With Locally Advanced or Metastatic Solid Tumors

Sponsor

Parabilis Medicines, Inc.

Enrollment

595 participants

Start Date

May 23, 2023

Study Type

INTERVENTIONAL

Conditions

Cancer

Summary

The goal of this clinical trial is to determine if FOG-001 is safe and effective in participants with locally advanced or metastatic solid tumors.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called FOG-001, which targets the WNT signaling pathway — a cellular communication system that is abnormally switched on in certain cancers. The trial tests FOG-001 alone and in combination with other treatments for people with advanced solid tumors, particularly colorectal cancer, liver cancer, desmoid tumors (a rare soft tissue growth), and other tumors with specific WNT pathway mutations. **You may be eligible if:** - You have advanced or metastatic cancer that has stopped responding to standard treatments - Your cancer has specific gene changes in the WNT pathway (such as APC or CTNNB1 mutations), depending on the study group - You are in good physical health (ECOG 0–1) with adequate organ function - Specific tumor types that may qualify include: colorectal cancer, liver cancer (hepatocellular carcinoma), desmoid tumors, or other solid tumors with documented WNT pathway mutations **You may NOT be eligible if:** - Your colorectal cancer is MSI-H or dMMR (a specific molecular subtype) - Your liver cancer does not have confirmed APC or CTNNB1 mutations (for some cohorts) - Your tumor lacks the required WNT pathway mutations for your specific cohort - Your organ function does not meet study requirements 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

DRUGFOG-001

FOG-001 will be administered IV at assigned doses in continuous cycles of 28 days

DRUGmFOLFOX-6

mFOLFOX-6 will be administered per the prescribing information in combination with FOG-001

DRUGNivolumab

Nivolumab will be administered per the prescribing information in combination with FOG-001

DRUGTrifluridine/tipiracil

Trifluridine/tipiracil will be administered per the prescribing information in combination with FOG-001

DRUGBevacizumab

Bevacizumab will be administered per the prescribing information in combination with FOG-001

DRUGFOG-001

FOG-001 will be administered subcutaneous at assigned doses in continuous cycles of 28 days

Locations(25)

Honor Health

Scottsdale, Arizona, United States

Arizona Cancer Center at University of Arizona

Tucson, Arizona, United States

University of California, Los Angeles (UCLA)

Los Angeles, California, United States

Stanford Cancer Institute, Stanford University

Palo Alto, California, United States

University of California San Francisco, Helen Diller Family Comprehensive Cancer Center

San Francisco, California, United States

Sarcoma Oncology Center

Santa Monica, California, United States

Yale University School of Medicine

New Haven, Connecticut, United States

Johns Hopkins University, Sibley Memorial Hospital

Washington D.C., District of Columbia, United States

Florida Cancer Specialists

Lake Mary, Florida, United States

Johns Hopkins University, The Sidney Kimmel Comprehensive Cancer Center

Baltimore, Maryland, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

M Health Fairview University of Minnesota Medical Center

Minneapolis, Minnesota, United States

Washington University School of Medicine

St Louis, Missouri, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

University Hospitals Cleveland Medical Center, Seidman Cancer Center

Cleveland, Ohio, United States

Cleveland Clinic

Cleveland, Ohio, United States

Oregon Health and Science University

Portland, Oregon, United States

University of Pittsburgh Medical Center, Hillman Cancer Center

Pittsburgh, Pennsylvania, United States

Sarah Cannon Research Institute

Nashville, Tennessee, United States

Vanderbilt Ingram Cancer Center

Nashville, Tennessee, United States

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States

South Texas Accelerated Research Therapeutics, LLC

San Antonio, Texas, United States

University of Virginia

Charlottesville, Virginia, United States

University of Wisconsin, Carbone Cancer Center

Madison, Wisconsin, United States

View Full Details on ClinicalTrials.gov

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