RecruitingPhase 1NCT04485013

TTX-080 HLA-G Antagonist in Subjects With Advanced Cancers

A Phase 1a/1b Dose Escalation/Expansion Study of TTX-080, an HLA-G Antagonist, as Monotherapy and in Combination With Pembrolizumab, Cetuximab or FOLFIRI Plus Cetuximab in Patients With Advanced Solid Refractory/Resistant Malignancies

Sponsor

Tizona Therapeutics, Inc

Enrollment

240 participants

Start Date

Jul 14, 2020

Study Type

INTERVENTIONAL

Conditions

Cancer

Summary

TTX-080-001 is a Phase 1, open label, dose escalation and dose expansion clinical study to determine the safety, tolerability, and recommended Phase 2 dose of TTX-080 monotherapy (HLA-G inhibitor) and in combination with either pembrolizumab (PD-1 inhibitor), cetuximab (EGFR inhibitor) or FOLFIRI plus cetuximab (EGFR inhibitor) in patients with advanced refractory / resistant solid malignancies including metastatic colorectal cancer (mCRC) patients.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests an experimental drug called TTX-080, which blocks a protein called HLA-G that some tumors use to hide from the immune system. It is currently enrolling patients with advanced colorectal cancer who have run out of standard treatment options. **You may be eligible if...** - You have advanced or metastatic colorectal cancer confirmed by biopsy - Your cancer has measurable disease on imaging - You are 18 or older with good performance status (able to care for yourself) - You have received and progressed through standard chemotherapy options **You may NOT be eligible if...** - You have a history of severe allergic reactions to similar drugs - You have received another experimental treatment within 28 days - You are on high-dose corticosteroids or immunosuppressants - 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

DRUGTTX-080

Variable dose (Q3W)

DRUGTTX-080

Specified dose (Q3W)

DRUGpembrolizumab

Specified dose (Q3W)

DRUGcetuximab

Specified dose on specified days

DRUGFOLFIRI

Specified dose (Q2W)

DRUGcetuximab

Specified dose (Q2W)

DRUGTTX-080

Specified dose (Q2W)

Locations(41)

Arizona Oncology Associates

Tucson, Arizona, United States

University of Southern California

Los Angeles, California, United States

Hoag Memorial Hospital

Newport Beach, California, United States

Rocky Mountain Cancer Centers

Denver, Colorado, United States

Yale Cancer Center

New Haven, Connecticut, United States

Christiana Care Helen F. Graham Cancer Center

Newark, Delaware, United States

John Hopkins Kimmer Cancer Center

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

Florida Cancer Specialists

Daytona Beach, Florida, United States

Florida Cancer Specialists

Fleming Island, Florida, United States

Ocala Oncology Center

Ocala, Florida, United States

AdventHealth Research Institute

Orlando, Florida, United States

Illinois Cancer Specialists

Arlington Heights, Illinois, United States

University of Illinois

Chicago, Illinois, United States

Indiana University

Indianapolis, Indiana, United States

Norton Cancer Institute

Louisville, Kentucky, United States

American Oncology Partners, P.A. - The Center for Cancer & Blood Disorders

Bethesda, Maryland, United States

Maryland Oncology Hematology

Silver Spring, Maryland, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

START Midwest

Grand Rapids, Michigan, United States

Regions Hospital Cancer Care Center

Saint Paul, Minnesota, United States

Washington University in St Louis

St Louis, Missouri, United States

Nebraska Cancer Center Oncology Hematology West P.C.

Omaha, Nebraska, United States

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, United States

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Stony Brook University

Stony Brook, New York, United States

University of Cincinnati

Cincinnati, Ohio, United States

Zangmeister Cancer Center

Columbus, Ohio, United States

The University of Toledo

Toledo, Ohio, United States

University of Oklahoma

Oklahoma City, Oklahoma, United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Medical University of South Carolina

Charleston, South Carolina, United States

Sarah Cannon Research Institute

Nashville, Tennessee, United States

Vanderbilt - Ingram Cancer Center

Nashville, Tennessee, United States

Texas Oncology - Dallas

Dallas, Texas, United States

START Dallas

Fort Worth, Texas, United States

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Texas Oncology - Paris

Paris, Texas, United States

NEXT Oncology

San Antonio, Texas, United States

NEXT Oncology Virginia

Fairfax, Virginia, United States

Northwest Medical Specialties

Tacoma, Washington, United States

Northwest Cancer Specialists

Vancouver, Washington, United States

View Full Details on ClinicalTrials.gov

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NCT04485013

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