Recruiting

Phase 1

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

Sponsor:

Tizona Therapeutics, Inc

Code:

NCT04485013

Conditions

Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

TTX-080

pembrolizumab

cetuximab

FOLFIRI

Study Details

Brief 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.

Conditions

Cancer

Study ID

NCT04485013

Start date

Jul 14, 2020

Status verified date

Dec, 2025

Completion date

Jun 1, 2027

Anticipated

Primary completion date

Jun 1, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

240 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Phase 1a, Monotherapy Dose Escalation

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) \[Closed\]

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) \[Closed\]

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

Arm 3 will enroll subjects with advanced/metastatic colorectal cancer (CRC) \[Closed\]

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 \[Closed\]

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 \[Closed\]

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

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

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) \[Closed\]

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

\[Closed\]

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.

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.

Interventions

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)

Primary outcome measure

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 ]

Central Contacts and Locations

Central contacts

Tizona Therapeutics, Inc.

888-585-2990 clinicaltrials@tizonatx.com

Locations

Rocky Mountain Cancer Centers

Recruiting

Denver, Colorado, United States, 80218

Contacts

303-388-4876

Florida Cancer Specialists

Recruiting

Daytona Beach, Florida, United States, 32117

Contacts

386-231-4060

Ocala Oncology Center

Recruiting

Ocala, Florida, United States, 34474

Contacts

352-547-1958

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

Recruiting

Bethesda, Maryland, United States, 20817

Contacts

301-571-2016

Maryland Oncology Hematology

Recruiting

Silver Spring, Maryland, United States, 20904

Contacts

301-933-3216

START Midwest

Recruiting

Grand Rapids, Michigan, United States, 49546

Contacts

616-954-5554

Regions Hospital Cancer Care Center

Recruiting

Saint Paul, Minnesota, United States, 55101

Contacts

651-254-3602

Nebraska Cancer Center Oncology Hematology West P.C.

Recruiting

Omaha, Nebraska, United States, 68130

Contacts

402-691-6971

Rutgers Cancer Institute of New Jersey

Recruiting

New Brunswick, New Jersey, United States, 08903

Contacts

732-235-3253

University of Cincinnati

Recruiting

Cincinnati, Ohio, United States, 45267

Contacts

513-584-5680

University of Oklahoma

Recruiting

Oklahoma City, Oklahoma, United States, 73104

Contacts

405-271-8001

Sarah Cannon Research Institute

Recruiting

Nashville, Tennessee, United States, 37203

Contacts

615-524-4203

Texas Oncology - Dallas

Recruiting

Dallas, Texas, United States, 75246

Contacts

214-370-1000

START Dallas

Recruiting

Fort Worth, Texas, United States, 76104

Contacts

682-350-3010

Texas Oncology - Paris

Recruiting

Paris, Texas, United States, 75460

Contacts

903-785-0031

NEXT Oncology Virginia

Recruiting

Fairfax, Virginia, United States, 22031

Contacts

703-280-5290

More Information

Sponsor

Tizona Therapeutics, Inc

Last update posted

Feb 18, 2026

Last verified

Dec, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Tizona Therapeutics, Inc on 2026-02-18.