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New Immune-Boosting drug takes on Hard-to-Treat cancers

NCT ID NCT04485013

Disease control Sponsor: Tizona Therapeutics, Inc Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Sep 11, 2026 · Updated 2 times

Summary

This early-phase trial is testing an experimental drug called TTX-080, which blocks a protein (HLA-G) that tumors use to hide from the immune system. The study will give TTX-080 alone or combined with other cancer drugs (pembrolizumab, cetuximab, or FOLFIRI plus cetuximab) to about 240 adults with advanced solid tumors that have not responded to standard treatments. The main goals are to find a safe dose and see if the drug shrinks tumors.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
TTX-080 (an experimental drug that blocks HLA-G, a protein that helps tumors hide from the immune system)
What this could lead to
If this works, it could provide a new treatment option for people with advanced cancers that have stopped responding to other therapies.
What could go wrong
This is a very early Phase 1 trial, so the drug may not work or may have serious side effects. Only a small number of people will be tested, and results may not apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 240 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2020

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Adenocarcinoma of Lung breast neoplasm cancer colorectal cancer colorectal neoplasm endometrium neoplasm gastric neoplasm Head and Neck Neoplasms kidney cancer lung neoplasm melanoma neoplasm Neoplasm Metastasis ovarian cancer prostate cancer renal cell carcinoma Squamous Cell Carcinoma of Head and Neck triple-negative breast carcinoma Urinary Bladder Neoplasms Uterine Cervical Neoplasms

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cancer

Contacts and locations

Locations

  • AdventHealth Research Institute

    Orlando, Florida, 32804, United States

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

    Bethesda, Maryland, 20817, United States

  • Arizona Oncology Associates

    Tucson, Arizona, 85711, United States

  • Christiana Care Helen F. Graham Cancer Center

    Newark, Delaware, 19713, United States

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215, United States

  • Florida Cancer Specialists

    Daytona Beach, Florida, 32117, United States

  • Florida Cancer Specialists

    Fleming Island, Florida, 32003, United States

  • Hoag Memorial Hospital

    Newport Beach, California, 92663, United States

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029, United States

  • Illinois Cancer Specialists

    Arlington Heights, Illinois, 60005, United States

  • Indiana University

    Indianapolis, Indiana, 46202, United States

  • John Hopkins Kimmer Cancer Center

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

  • Maryland Oncology Hematology

    Silver Spring, Maryland, 20904, United States

  • Medical University of South Carolina

    Charleston, South Carolina, 29425, United States

  • NEXT Oncology

    San Antonio, Texas, 78229, United States

  • NEXT Oncology Virginia

    Fairfax, Virginia, 22031, United States

  • Nebraska Cancer Center Oncology Hematology West P.C.

    Omaha, Nebraska, 68130, United States

  • Northwest Cancer Specialists

    Vancouver, Washington, 98684, United States

  • Northwest Medical Specialties

    Tacoma, Washington, 98405, United States

  • Norton Cancer Institute

    Louisville, Kentucky, 40241, United States

  • Ocala Oncology Center

    Ocala, Florida, 34474, United States

  • Regions Hospital Cancer Care Center

    Saint Paul, Minnesota, 55101, United States

  • Rocky Mountain Cancer Centers

    Denver, Colorado, 80218, United States

  • Rutgers Cancer Institute of New Jersey

    New Brunswick, New Jersey, 08903, United States

  • START Dallas

    Fort Worth, Texas, 76104, United States

  • START Midwest

    Grand Rapids, Michigan, 49546, United States

  • Sarah Cannon Research Institute

    Nashville, Tennessee, 37203, United States

  • Stony Brook University

    Stony Brook, New York, 11794, United States

  • Texas Oncology - Dallas

    Dallas, Texas, 75246, United States

  • Texas Oncology - Paris

    Paris, Texas, 75460, United States

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030, United States

  • The University of Toledo

    Toledo, Ohio, 43606, United States

  • University of Cincinnati

    Cincinnati, Ohio, 45267, United States

  • University of Illinois

    Chicago, Illinois, 60612, United States

  • University of Oklahoma

    Oklahoma City, Oklahoma, 73104, United States

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15232, United States

  • University of Southern California

    Los Angeles, California, 90033, United States

  • Vanderbilt - Ingram Cancer Center

    Nashville, Tennessee, 37232, United States

  • Washington University in St Louis

    St Louis, Missouri, 63110, United States

  • Yale Cancer Center

    New Haven, Connecticut, 06511, United States

  • Zangmeister Cancer Center

    Columbus, Ohio, 43219, United States

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