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HLA-G Antagonist Treatment for Advanced Cancers

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

PHASE1 · Tizona Therapeutics, Inc · NCT04485013

This study is testing a new drug called TTX-080 to see if it can help people with advanced cancers feel better and fight their tumors, either on its own or with other treatments.

Quick facts

PhasePHASE1
Study typeInterventional
Enrollment240 (estimated)
Ages18 Years and up
SexAll
SponsorTizona Therapeutics, Inc (industry)
Drugs / interventionspembrolizumab, cetuximab
Locations41 sites (Tucson, Arizona and 40 other locations)
Trial IDNCT04485013 on ClinicalTrials.gov

What this trial studies

This Phase 1 clinical trial evaluates the safety and tolerability of TTX-080, an HLA-G inhibitor, in patients with advanced refractory solid tumors. The study includes a dose escalation phase to determine the maximum tolerated dose and a dose expansion phase where TTX-080 is tested alone and in combination with pembrolizumab or cetuximab. Patients with various types of advanced cancers, including metastatic colorectal cancer and triple negative breast cancer, will be enrolled to assess the drug's pharmacokinetics and anti-tumor activity.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with a histological diagnosis of advanced or metastatic cancer and measurable disease.

Not a fit: Patients with severe autoimmune diseases or those currently receiving high-dose immunosuppressive therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced cancers that are resistant to existing therapies.

How similar studies have performed: While this approach is novel in targeting HLA-G, similar studies using immune checkpoint inhibitors have shown promise in treating advanced cancers.

Eligibility criteria

Show full inclusion / exclusion criteria 
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

Where this trial is running

Tucson, Arizona and 40 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Cancer, HLA-G, TTX-080, Advanced Solid Tumor, Ovarian Cancer, Endometrial Cancer, Cervical Cancer, Kidney Cancer

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.