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

NCT ID: NCT04485013

Last Updated: 2025-11-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-14

Study Completion Date

2027-06-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Cancer

Keywords

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HLA-G TTX-080 Advanced Solid Tumor Cancer Ovarian Cancer Endometrial Cancer Cervical Cancer Kidney Cancer Head and Neck Squamous Cell Carcinoma Squamous Cell Lung Cancer Prostate Cancer Colorectal Cancer Gastric Cancer Breast Cancer Bladder Cancer Lung Adenocarcinoma Melanoma Metastatic Solid Tumor Renal cell carcinoma Acral melanoma Triple Negative Breast Cancer Pembrolizumab Cetuximab Antineoplastic Agents, Immunological Antineoplastic Agents Head and Neck Cancer Lung Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Phase 1a, Monotherapy Dose Escalation

Group Type EXPERIMENTAL

TTX-080

Intervention Type DRUG

Variable dose (Q3W)

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)

Group Type EXPERIMENTAL

TTX-080

Intervention Type DRUG

Specified dose (Q3W)

pembrolizumab

Intervention Type DRUG

Specified dose (Q3W)

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)

Group Type EXPERIMENTAL

TTX-080

Intervention Type DRUG

Specified dose (Q3W)

cetuximab

Intervention Type DRUG

Specified dose on specified days

Phase 1b, Dose Expansion: TTX-080 monotherapy (CRC)

Arm 3 will enroll subjects with advanced/metastatic colorectal cancer (CRC)

Group Type EXPERIMENTAL

TTX-080

Intervention Type DRUG

Specified dose (Q3W)

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

Group Type EXPERIMENTAL

TTX-080

Intervention Type DRUG

Specified dose (Q3W)

cetuximab

Intervention Type DRUG

Specified dose on specified days

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

Group Type EXPERIMENTAL

TTX-080

Intervention Type DRUG

Specified dose (Q3W)

cetuximab

Intervention Type DRUG

Specified dose on specified days

Phase 1b, Dose Expansion: TTX-080 monotherapy (NSCLC)

Arm 6 will enroll subjects with advanced/metastatic non-small cell lung cancer (NSCLC)

Group Type EXPERIMENTAL

TTX-080

Intervention Type DRUG

Specified dose (Q3W)

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)

Group Type EXPERIMENTAL

TTX-080

Intervention Type DRUG

Specified dose (Q3W)

pembrolizumab

Intervention Type DRUG

Specified dose (Q3W)

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

Group Type EXPERIMENTAL

TTX-080

Intervention Type DRUG

Specified dose (Q3W)

pembrolizumab

Intervention Type DRUG

Specified dose (Q3W)

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.

Group Type EXPERIMENTAL

FOLFIRI

Intervention Type DRUG

Specified dose (Q2W)

cetuximab

Intervention Type DRUG

Specified dose (Q2W)

TTX-080

Intervention Type DRUG

Specified dose (Q2W)

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.

Group Type EXPERIMENTAL

FOLFIRI

Intervention Type DRUG

Specified dose (Q2W)

cetuximab

Intervention Type DRUG

Specified dose (Q2W)

Interventions

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TTX-080

Variable dose (Q3W)

Intervention Type DRUG

TTX-080

Specified dose (Q3W)

Intervention Type DRUG

pembrolizumab

Specified dose (Q3W)

Intervention Type DRUG

cetuximab

Specified dose on specified days

Intervention Type DRUG

FOLFIRI

Specified dose (Q2W)

Intervention Type DRUG

cetuximab

Specified dose (Q2W)

Intervention Type DRUG

TTX-080

Specified dose (Q2W)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Subject with histological diagnosis of advanced/metastatic cancer
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

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tizona Therapeutics, Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Arizona Oncology Associates

Tucson, Arizona, United States

Site Status COMPLETED

University of Southern California

Los Angeles, California, United States

Site Status COMPLETED

Hoag Memorial Hospital

Newport Beach, California, United States

Site Status COMPLETED

Rocky Mountain Cancer Centers

Denver, Colorado, United States

Site Status RECRUITING

Yale Cancer Center

New Haven, Connecticut, United States

Site Status COMPLETED

Christiana Care Helen F. Graham Cancer Center

Newark, Delaware, United States

Site Status COMPLETED

John Hopkins Kimmer Cancer Center

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

Site Status COMPLETED

Florida Cancer Specialists

Daytona Beach, Florida, United States

Site Status RECRUITING

Florida Cancer Specialists

Fleming Island, Florida, United States

Site Status COMPLETED

Ocala Oncology Center

Ocala, Florida, United States

Site Status RECRUITING

AdventHealth Research Institute

Orlando, Florida, United States

Site Status COMPLETED

Illinois Cancer Specialists

Arlington Heights, Illinois, United States

Site Status COMPLETED

University of Illinois

Chicago, Illinois, United States

Site Status COMPLETED

Indiana University

Indianapolis, Indiana, United States

Site Status COMPLETED

Norton Cancer Institute

Louisville, Kentucky, United States

Site Status COMPLETED

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

Bethesda, Maryland, United States

Site Status RECRUITING

Maryland Oncology Hematology

Silver Spring, Maryland, United States

Site Status RECRUITING

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Site Status RECRUITING

START Midwest

Grand Rapids, Michigan, United States

Site Status COMPLETED

Regions Hospital Cancer Care Center

Saint Paul, Minnesota, United States

Site Status RECRUITING

Washington University in St Louis

St Louis, Missouri, United States

Site Status COMPLETED

Nebraska Cancer Center Oncology Hematology West P.C.

Omaha, Nebraska, United States

Site Status RECRUITING

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, United States

Site Status RECRUITING

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Site Status COMPLETED

Stony Brook University

Stony Brook, New York, United States

Site Status COMPLETED

University of Cincinnati

Cincinnati, Ohio, United States

Site Status RECRUITING

Zangmeister Cancer Center

Columbus, Ohio, United States

Site Status COMPLETED

The University of Toledo

Toledo, Ohio, United States

Site Status COMPLETED

University of Oklahoma

Oklahoma City, Oklahoma, United States

Site Status RECRUITING

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Site Status COMPLETED

Medical University of South Carolina

Charleston, South Carolina, United States

Site Status COMPLETED

Sarah Cannon Research Institute

Nashville, Tennessee, United States

Site Status RECRUITING

Vanderbilt - Ingram Cancer Center

Nashville, Tennessee, United States

Site Status COMPLETED

Texas Oncology - Dallas

Dallas, Texas, United States

Site Status RECRUITING

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Site Status COMPLETED

Texas Oncology - Paris

Paris, Texas, United States

Site Status RECRUITING

NEXT Oncology

San Antonio, Texas, United States

Site Status COMPLETED

NEXT Oncology Virginia

Fairfax, Virginia, United States

Site Status RECRUITING

Northwest Medical Specialties

Tacoma, Washington, United States

Site Status COMPLETED

Northwest Cancer Specialists

Vancouver, Washington, United States

Site Status COMPLETED

Countries

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United States

Central Contacts

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Tizona Therapeutics, Inc.

Role: CONTACT

Phone: 888-585-2990

Email: [email protected]

Facility Contacts

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Role: primary

Role: primary

Role: primary

Role: primary

Role: primary

Role: primary

Role: primary

Role: primary

Role: primary

Role: primary

Role: primary

Role: primary

Role: primary

Role: primary

Role: primary

Other Identifiers

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TTX-080-001

Identifier Type: -

Identifier Source: org_study_id