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TTX-080 HLA-G Antagonist in Subjects With Advanced Cancers
Trial Status: active
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.
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 AND life expectancy of at least 12 weeks Abbreviated
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
Additional locations may be listed on ClinicalTrials.gov for NCT04485013.
Locations matching your search criteria
United States
Oklahoma
Oklahoma City
University of Oklahoma Health Sciences Center
Status: Active
Name Not Available
Pennsylvania
Pittsburgh
University of Pittsburgh Cancer Institute (UPCI)
Status: Active
Name Not Available
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.
