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

Trial Status: Active

TTX-080-01 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) or cetuximab (EGFR inhibitor) in patients with advanced refractory / resistant solid malignancies. The study is enrolling in the dose expansion cohorts.

Inclusion Criteria

  • Subject with histological diagnosis of advanced/metastatic cancer
  • Age 18 years or older, is willing and able to provide informed consent
  • Evidence of measurable disease
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1

Exclusion Criteria

  • History of allergy or hypersensitivity to study treatment components. Subjects with a history of severe hypersensitivity reaction to any monoclonal antibody
  • Use of an investigational agent within 28 days prior to the first dose of study treatment and throughout the study
  • Receiving high-dose systemic steroid therapy or any other form of immunosuppressive therapy
  • History of severe autoimmune disease
  • Uncontrolled intercurrent illness or other active malignancy requiring ongoing treatment

California

Los Angeles
UCLA / Jonsson Comprehensive Cancer Center
Status: ACTIVE
Contact: Rachel Andes
Phone: 310-582-4062
USC / Norris Comprehensive Cancer Center
Status: ACTIVE
Contact: Xiomara Menendez
Phone: 323-865-0212

Connecticut

New Haven
Yale University
Status: TEMPORARILY_CLOSED_TO_ACCRUAL

Indiana

Indianapolis
Indiana University / Melvin and Bren Simon Cancer Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL

Iowa

Iowa City
University of Iowa / Holden Comprehensive Cancer Center
Status: IN_REVIEW

Massachusetts

Boston
Beth Israel Deaconess Medical Center
Status: APPROVED
Brigham and Women's Hospital
Status: ACTIVE
Dana-Farber Cancer Institute
Status: ACTIVE

Missouri

Saint Louis
Siteman Cancer Center at Washington University
Status: ACTIVE

New Jersey

New Brunswick
Rutgers Cancer Institute of New Jersey
Status: ACTIVE

New York

New York
Icahn School of Medicine at Mount Sinai
Status: ACTIVE

North Carolina

Winston-Salem
Wake Forest University Health Sciences
Status: WITHDRAWN

Oklahoma

Oklahoma City
University of Oklahoma Health Sciences Center
Status: ACTIVE

Pennsylvania

Pittsburgh
University of Pittsburgh Cancer Institute (UPCI)
Status: ACTIVE

South Carolina

Charleston
Medical University of South Carolina
Status: ACTIVE

Tennessee

Nashville
Vanderbilt University / Ingram Cancer Center
Status: ACTIVE

Texas

Houston
M D Anderson Cancer Center
Status: ACTIVE

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), and triple

negative breast cancer (TNBC). Additionally, the study will seek to evaluate the

pharmacokinetics and immunogenicity of TTX-080, and preliminary efficacy of TTX-080 as a

monotherapy and in combination with pembrolizumab or cetuximab.

The study is enrolling in the dose expansion cohorts.

Trial Phase Phase I

Trial Type Treatment

Lead Organization
Tizona Therapeutics, Inc

  • Primary ID TTX-080-001
  • Secondary IDs NCI-2020-07730
  • Clinicaltrials.gov ID NCT04485013