Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT04485013

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

Led by Tizona Therapeutics, Inc · Updated on 2026-02-18

240

Participants Needed

41

Research Sites

359 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Histological diagnosis of advanced or metastatic cancer (currently enrolling colorectal cancer only)
  • Age 18 years or older and able to provide informed consent
  • Evidence of measurable disease
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1
  • Life expectancy of at least 12 weeks
Not Eligible

You will not qualify if you...

  • History of allergy or severe hypersensitivity to study treatment components or monoclonal antibodies
  • Use of any investigational drug within 28 days before starting study treatment or during the study
  • Receiving high-dose systemic steroids or other immunosuppressive therapies
  • History of severe autoimmune disease
  • Uncontrolled illness or another active cancer requiring treatment

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 41 locations

1

Arizona Oncology Associates

Tucson, Arizona, United States, 85711

Completed

2

University of Southern California

Los Angeles, California, United States, 90033

Completed

3

Hoag Memorial Hospital

Newport Beach, California, United States, 92663

Completed

4

Rocky Mountain Cancer Centers

Denver, Colorado, United States, 80218

Actively Recruiting

5

Yale Cancer Center

New Haven, Connecticut, United States, 06511

Completed

6

Christiana Care Helen F. Graham Cancer Center

Newark, Delaware, United States, 19713

Completed

7

John Hopkins Kimmer Cancer Center

Washington D.C., District of Columbia, United States, 20016

Completed

8

Florida Cancer Specialists

Daytona Beach, Florida, United States, 32117

Actively Recruiting

9

Florida Cancer Specialists

Fleming Island, Florida, United States, 32003

Completed

10

Ocala Oncology Center

Ocala, Florida, United States, 34474

Actively Recruiting

11

AdventHealth Research Institute

Orlando, Florida, United States, 32804

Completed

12

Illinois Cancer Specialists

Arlington Heights, Illinois, United States, 60005

Completed

13

University of Illinois

Chicago, Illinois, United States, 60612

Completed

14

Indiana University

Indianapolis, Indiana, United States, 46202

Completed

15

Norton Cancer Institute

Louisville, Kentucky, United States, 40241

Completed

16

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

Bethesda, Maryland, United States, 20817

Actively Recruiting

17

Maryland Oncology Hematology

Silver Spring, Maryland, United States, 20904

Actively Recruiting

18

Dana-Farber Cancer Institute

Boston, Massachusetts, United States, 02215

Completed

19

START Midwest

Grand Rapids, Michigan, United States, 49546

Actively Recruiting

20

Regions Hospital Cancer Care Center

Saint Paul, Minnesota, United States, 55101

Actively Recruiting

21

Washington University in St Louis

St Louis, Missouri, United States, 63110

Completed

22

Nebraska Cancer Center Oncology Hematology West P.C.

Omaha, Nebraska, United States, 68130

Actively Recruiting

23

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, United States, 08903

Actively Recruiting

24

Icahn School of Medicine at Mount Sinai

New York, New York, United States, 10029

Completed

25

Stony Brook University

Stony Brook, New York, United States, 11794

Completed

26

University of Cincinnati

Cincinnati, Ohio, United States, 45267

Actively Recruiting

27

Zangmeister Cancer Center

Columbus, Ohio, United States, 43219

Completed

28

The University of Toledo

Toledo, Ohio, United States, 43606

Completed

29

University of Oklahoma

Oklahoma City, Oklahoma, United States, 73104

Actively Recruiting

30

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States, 15232

Completed

31

Medical University of South Carolina

Charleston, South Carolina, United States, 29425

Completed

32

Sarah Cannon Research Institute

Nashville, Tennessee, United States, 37203

Actively Recruiting

33

Vanderbilt - Ingram Cancer Center

Nashville, Tennessee, United States, 37232

Completed

34

Texas Oncology - Dallas

Dallas, Texas, United States, 75246

Actively Recruiting

35

START Dallas

Fort Worth, Texas, United States, 76104

Actively Recruiting

36

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States, 77030

Completed

37

Texas Oncology - Paris

Paris, Texas, United States, 75460

Actively Recruiting

38

NEXT Oncology

San Antonio, Texas, United States, 78229

Completed

39

NEXT Oncology Virginia

Fairfax, Virginia, United States, 22031

Actively Recruiting

40

Northwest Medical Specialties

Tacoma, Washington, United States, 98405

Completed

41

Northwest Cancer Specialists

Vancouver, Washington, United States, 98684

Completed

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Research Team

T

Tizona Therapeutics, Inc.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

11

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