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

February 13, 2026 updated by: Tizona Therapeutics, Inc

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

TTX-080 is a fully human mAb designed to block the interaction of HLA-G with its known ligands, ILT2 and ILT4 molecules. The Phase 1a was an open label, multicenter, dose escalation clinical trial to determine the safety, tolerability, MTD or OBD, and the RP2D of TTX-080 when administered as a single agent. The Phase 1b is a dose expansion of TTX-080 monotherapy and in combination with either pembrolizumab or cetuximab in adult subjects with advanced refractory/resistant solid malignancies, including Head and Neck squamous cell carcinoma (HNSCC), Non-Small Cell Lung Cancer (NSCLC), Colorectal cancer (CRC), triple negative breast cancer (TNBC), renal cell carcinoma (RCC), and acral melanoma. Additionally, the Phase 1b includes randomized arms with TTX-080 in combination with FOLFIRI plus cetuximab compared to FOLFIRI plus cetuximab in metastatic Colorectal cancer. The study will seek to evaluate the pharmacokinetics and immunogenicity of TTX-080, and characterize the anti-tumor activity of TTX-080 as a monotherapy and in combination with pembrolizumab, cetuximab or FOLFIRI plus cetuximab. Only arm 9 and 10 are currently open to enrollment.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
240

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Arizona
      • Tucson, Arizona, United States, 85711
        • Completed
        • Arizona Oncology Associates
    • California
      • Los Angeles, California, United States, 90033
        • Completed
        • University of Southern California
      • Newport Beach, California, United States, 92663
        • Completed
        • Hoag Memorial Hospital
    • Colorado
      • Denver, Colorado, United States, 80218
        • Recruiting
        • Rocky Mountain Cancer Centers
        • Contact:
          • Phone Number: 303-388-4876
    • Connecticut
      • New Haven, Connecticut, United States, 06511
        • Completed
        • Yale Cancer Center
    • Delaware
      • Newark, Delaware, United States, 19713
        • Completed
        • Christiana Care Helen F. Graham Cancer Center
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20016
        • Completed
        • John Hopkins Kimmer Cancer Center
    • Florida
      • Daytona Beach, Florida, United States, 32117
        • Recruiting
        • Florida Cancer Specialists
        • Contact:
          • Phone Number: 386-231-4060
      • Fleming Island, Florida, United States, 32003
        • Completed
        • Florida Cancer Specialists
      • Ocala, Florida, United States, 34474
        • Recruiting
        • Ocala Oncology Center
        • Contact:
          • Phone Number: 352-547-1958
      • Orlando, Florida, United States, 32804
        • Completed
        • AdventHealth Research Institute
    • Illinois
      • Arlington Heights, Illinois, United States, 60005
        • Completed
        • Illinois Cancer Specialists
      • Chicago, Illinois, United States, 60612
        • Completed
        • University of Illinois
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Completed
        • Indiana University
    • Kentucky
      • Louisville, Kentucky, United States, 40241
        • Completed
        • Norton Cancer Institute
    • Maryland
      • Bethesda, Maryland, United States, 20817
        • Recruiting
        • American Oncology Partners, P.A. - The Center for Cancer & Blood Disorders
        • Contact:
          • Phone Number: 2110 301-571-2016
      • Silver Spring, Maryland, United States, 20904
        • Recruiting
        • Maryland Oncology Hematology
        • Contact:
          • Phone Number: 301-933-3216
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Completed
        • Dana-Farber Cancer Institute
    • Michigan
      • Grand Rapids, Michigan, United States, 49546
        • Recruiting
        • START Midwest
        • Contact:
          • Phone Number: 616-954-5554
    • Minnesota
      • Saint Paul, Minnesota, United States, 55101
        • Recruiting
        • Regions Hospital Cancer Care Center
        • Contact:
          • Phone Number: 651-254-3602
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Completed
        • Washington University in St Louis
    • Nebraska
      • Omaha, Nebraska, United States, 68130
        • Recruiting
        • Nebraska Cancer Center Oncology Hematology West P.C.
        • Contact:
          • Phone Number: 402-691-6971
    • New Jersey
      • New Brunswick, New Jersey, United States, 08903
        • Recruiting
        • Rutgers Cancer Institute of New Jersey
        • Contact:
          • Phone Number: 732-235-3253
    • New York
      • New York, New York, United States, 10029
        • Completed
        • Icahn School of Medicine at Mount Sinai
      • Stony Brook, New York, United States, 11794
        • Completed
        • Stony Brook University
    • Ohio
      • Cincinnati, Ohio, United States, 45267
        • Recruiting
        • University of Cincinnati
        • Contact:
          • Phone Number: 513-584-5680
      • Columbus, Ohio, United States, 43219
        • Completed
        • Zangmeister Cancer Center
      • Toledo, Ohio, United States, 43606
        • Completed
        • The University of Toledo
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Recruiting
        • University of Oklahoma
        • Contact:
          • Phone Number: 32084 405-271-8001
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15232
        • Completed
        • University of Pittsburgh Medical Center
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Completed
        • Medical University of South Carolina
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Recruiting
        • Sarah Cannon Research Institute
        • Contact:
          • Phone Number: 615-524-4203
      • Nashville, Tennessee, United States, 37232
        • Completed
        • Vanderbilt - Ingram Cancer Center
    • Texas
      • Dallas, Texas, United States, 75246
        • Recruiting
        • Texas Oncology - Dallas
        • Contact:
          • Phone Number: 214-370-1000
      • Fort Worth, Texas, United States, 76104
        • Recruiting
        • START Dallas
        • Contact:
          • Phone Number: 682-350-3010
      • Houston, Texas, United States, 77030
        • Completed
        • The University of Texas MD Anderson Cancer Center
      • Paris, Texas, United States, 75460
        • Recruiting
        • Texas Oncology - Paris
        • Contact:
          • Phone Number: 903-785-0031
      • San Antonio, Texas, United States, 78229
        • Completed
        • NEXT Oncology
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Recruiting
        • NEXT Oncology Virginia
        • Contact:
          • Phone Number: 703-280-5290
    • Washington
      • Tacoma, Washington, United States, 98405
        • Completed
        • Northwest Medical Specialties
      • Vancouver, Washington, United States, 98684
        • Completed
        • Northwest Cancer Specialists

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Phase 1a, Monotherapy Dose Escalation
Drug: TTX-080
Variable dose (Q3W)
Drug: TTX-080
Specified dose (Q3W)
Drug: TTX-080
Specified dose (Q2W)
Experimental: TTX-080 in combination with FOLFIRI plus cetuximab
Arm 9: TTX-080 in combination with FOLFIRI plus cetuximab Randomized Arms in subjects with metastatic RAS, BRAF and HER2 wild type colorectal cancer (CRC) who have been received oxaliplatin and 5-FU based chemotherapy in the first line or adjuvant (relapse within 6 months) setting. Prior bevacizumab allowed. No prior EGFR inhibitor.
Drug: TTX-080
Variable dose (Q3W)
Drug: TTX-080
Specified dose (Q3W)
Drug: cetuximab
Specified dose on specified days
Drug: TTX-080
Specified dose (Q2W)
Drug: cetuximab
Specified dose (Q2W)
Drug: FOLFIRI
Specified dose (Q2W)
Experimental: FOLFIRI plus cetuximab
Arm 10: FOLFIRI plus cetuximab Randomized Arms in subjects with metastatic RAS, BRAF and HER2 wild type colorectal cancer (CRC) who have been received oxaliplatin and 5-FU based chemotherapy in the first line or adjuvant (relapse within 6 months) setting. Prior bevacizumab allowed. No prior EGFR inhibitor.
Drug: cetuximab
Specified dose on specified days
Drug: cetuximab
Specified dose (Q2W)
Drug: FOLFIRI
Specified dose (Q2W)
Experimental: Phase 1b, Dose Expansion: TTX-080 in combination with pembrolizumab (HNSCC)
Arm 1 will enroll subjects with advanced/metastatic, prior checkpoint inhibitor treated Head and Neck Squamous Cell Carcinoma (HNSCC) [Closed]
Drug: TTX-080
Variable dose (Q3W)
Drug: TTX-080
Specified dose (Q3W)
Drug: pembrolizumab
Specified dose (Q3W)
Drug: TTX-080
Specified dose (Q2W)
Experimental: Phase 1b, Dose Expansion: TTX-080 in combination with cetuximab (HNSCC)
Arm 2 will enroll subjects with advanced/metastatic Head and Neck Squamous Cell Carcinoma (HNSCC) [Closed]
Drug: TTX-080
Variable dose (Q3W)
Drug: TTX-080
Specified dose (Q3W)
Drug: cetuximab
Specified dose on specified days
Drug: TTX-080
Specified dose (Q2W)
Drug: cetuximab
Specified dose (Q2W)
Experimental: Phase 1b, Dose Expansion: TTX-080 monotherapy (CRC)
Arm 3 will enroll subjects with advanced/metastatic colorectal cancer (CRC) [Closed]
Drug: TTX-080
Variable dose (Q3W)
Drug: TTX-080
Specified dose (Q3W)
Drug: TTX-080
Specified dose (Q2W)
Experimental: Phase 1b, Dose Expansion: TTX-080 in combination with cetuximab (CRC), prior anti-EGFR therapy
Arm 4 will enroll subjects with advanced/metastatic MSI-L/MSS, KRAS wild-type colorectal cancer (CRC) who have progressed on a prior anti-EGFR therapy [Closed]
Drug: TTX-080
Variable dose (Q3W)
Drug: TTX-080
Specified dose (Q3W)
Drug: cetuximab
Specified dose on specified days
Drug: TTX-080
Specified dose (Q2W)
Drug: cetuximab
Specified dose (Q2W)
Experimental: Phase 1b, Dose Expansion: TTX-080 in combination with cetuximab (CRC), no prior anti-EGFR therapy
Arm 5 will enroll subjects with advanced/metastatic MSI-L/MSS, KRAS wild type colorectal cancer (CRC) who have not received a prior anti-EGFR therapy [Closed]
Drug: TTX-080
Variable dose (Q3W)
Drug: TTX-080
Specified dose (Q3W)
Drug: cetuximab
Specified dose on specified days
Drug: TTX-080
Specified dose (Q2W)
Drug: cetuximab
Specified dose (Q2W)
Experimental: Phase 1b, Dose Expansion: TTX-080 monotherapy (NSCLC)
Arm 6 will enroll subjects with advanced/metastatic non-small cell lung cancer (NSCLC) [Closed]
Drug: TTX-080
Variable dose (Q3W)
Drug: TTX-080
Specified dose (Q3W)
Drug: TTX-080
Specified dose (Q2W)
Experimental: Phase 1b, Dose Expansion: TTX-080 in combination with pembrolizumab (NSCLC)
Arm 7 will enroll subjects with advanced/metastatic prior checkpoint inhibitor treated non-small cell lung cancer (NSCLC) [Closed]
Drug: TTX-080
Variable dose (Q3W)
Drug: TTX-080
Specified dose (Q3W)
Drug: pembrolizumab
Specified dose (Q3W)
Drug: TTX-080
Specified dose (Q2W)
Experimental: Phase 1b, Dose Expansion: TTX-080 as monotherapy OR in combination with pembrolizumab

Arm 8: TTX-080 monotherapy:

  • Advanced/metastatic, prior checkpoint inhibitor treated renal cell carcinoma with predominance of clear cell component
  • Advanced/metastatic acral melanoma

Arm 8: TTX-080 in combination with pembrolizumab:

• Advanced/metastatic triple-negative breast cancer (estrogen and progesterone receptor negative and HER2 negative) who has received a prior checkpoint inhibitor

[Closed]
Drug: TTX-080
Variable dose (Q3W)
Drug: TTX-080
Specified dose (Q3W)
Drug: pembrolizumab
Specified dose (Q3W)
Drug: TTX-080
Specified dose (Q2W)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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
Time Frame: Up to 48 months
Up to 48 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Duration of Response, Progression Free Survival per RECIST 1.1
Time Frame: Up to 48 months
Up to 48 months
Overall Survival
Time Frame: Up to 48 months
Up to 48 months
Adverse events (AEs) as characterized by the incidence, type, frequency, severity (graded according to NCI-CTCAE v5.0), timing, seriousness, and relationship to investigational product, and/or combination therapy, and/or individual approved therapies
Time Frame: Up to 48 months
Up to 48 months
Tolerability: The number of cycles of TTX-080 received by patients before discontinuing due to unmanageable drug reactions
Time Frame: Up to 48 months
Up to 48 months
Serum levels of Anti Drug Antibody against TTX-080
Time Frame: Up to 48 months
Up to 48 months
Cmax: Maximum Observed Plasma Concentration for TTX-080
Time Frame: Up to 48 months
Up to 48 months
Tmax: Time to Reach the Cmax for TTX-080
Time Frame: Up to 48 months
Up to 48 months
AUC(0-t): Area Under the Plasma Concentration-time Curve From Zero Time to the Last Measurable Point for TTX-080
Time Frame: Up to 48 months
Up to 48 months
AUC(0-Inf): Area Under the Plasma Concentration-time Curve From Zero to Infinity for TTX-080
Time Frame: Up to 48 months
Up to 48 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Tizona Therapeutics, Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 14, 2020

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 15, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 21, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 24, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 18, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 13, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TTX-080-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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