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

NCT04485013 · tracked via the Priya Life Science USA tracker

Sponsor

Tizona Therapeutics, Inc

Phase

Phase 1

Started

2020-07-14

Last updated

2026-09-11

Condition(s) studied

Cancer

Investigational drug(s) / intervention(s)

TTX-080TTX-080pembrolizumab →cetuximab →FOLFIRI →cetuximab →TTX-080

TTX-080: Variable dose (Q3W)

TTX-080: Specified dose (Q3W)

pembrolizumab: Specified dose (Q3W)

cetuximab: Specified dose on specified days

FOLFIRI: Specified dose (Q2W)

cetuximab: Specified dose (Q2W)

TTX-080: Specified dose (Q2W)

Study 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

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Abbreviated Inclusion Criteria: 1. Subject with histological diagnosis of advanced/metastatic cancer \[currently enrolling in CRC only\] 2. Age 18 years or older, is willing and able to provide informed consent 3. Evidence of measurable disease 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 AND life expectancy of at least 12 weeks Abbreviated Exclusion Criteria: 1. History of allergy or hypersensitivity to study treatment components. Subjects with a history of severe hypersensitivity reaction to any monoclonal antibody 2. Use of an investigational agent within 28 days prior to the first dose of study treatment and throughout the study 3. Receiving high-dose systemic steroid therapy or any other form of immunosuppressive therapy 4. History of severe autoimmune disease 5. Uncontrolled intercurrent illness or other active malignancy requiring ongoing treatment

Primary outcome measure(s)

1. To determine the anti-tumor activity of TTX-080 by objective response rate [complete response + partial response) for each tumor arm per RECIST 1.1 — Up to 48 months

Trial sites (41)

Facility	City	Region
Arizona Oncology Associates	Tucson	Arizona
University of Southern California	Los Angeles	California
Hoag Memorial Hospital	Newport Beach	California
Rocky Mountain Cancer Centers	Denver	Colorado
Yale Cancer Center	New Haven	Connecticut
Christiana Care Helen F. Graham Cancer Center	Newark	Delaware
John Hopkins Kimmer Cancer Center	Washington D.C.	District of Columbia
Florida Cancer Specialists	Daytona Beach	Florida
Florida Cancer Specialists	Fleming Island	Florida
Ocala Oncology Center	Ocala	Florida
AdventHealth Research Institute	Orlando	Florida
Illinois Cancer Specialists	Arlington Heights	Illinois
University of Illinois	Chicago	Illinois
Indiana University	Indianapolis	Indiana
Norton Cancer Institute	Louisville	Kentucky
American Oncology Partners, P.A. - The Center for Cancer & Blood Disorders	Bethesda	Maryland
Maryland Oncology Hematology	Silver Spring	Maryland
Dana-Farber Cancer Institute	Boston	Massachusetts
START Midwest	Grand Rapids	Michigan
Regions Hospital Cancer Care Center	Saint Paul	Minnesota
Washington University in St Louis	St Louis	Missouri
Nebraska Cancer Center Oncology Hematology West P.C.	Omaha	Nebraska
Rutgers Cancer Institute of New Jersey	New Brunswick	New Jersey
Icahn School of Medicine at Mount Sinai	New York	New York
Stony Brook University	Stony Brook	New York
University of Cincinnati	Cincinnati	Ohio
Zangmeister Cancer Center	Columbus	Ohio
The University of Toledo	Toledo	Ohio
University of Oklahoma	Oklahoma City	Oklahoma
University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
Medical University of South Carolina	Charleston	South Carolina
Sarah Cannon Research Institute	Nashville	Tennessee
Vanderbilt - Ingram Cancer Center	Nashville	Tennessee
Texas Oncology - Dallas	Dallas	Texas
START Dallas	Fort Worth	Texas
The University of Texas MD Anderson Cancer Center	Houston	Texas
Texas Oncology - Paris	Paris	Texas
NEXT Oncology	San Antonio	Texas
NEXT Oncology Virginia	Fairfax	Virginia
Northwest Medical Specialties	Tacoma	Washington

+ 1 more sites — see the full list on the official registry below.

On this site

📄 Keytruda (pembrolizumab) drug profile →

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04485013 on ClinicalTrials.gov ↗ ← All trials in the USA