A First-in-Human, Phase 1 Study to Evaluate the Safety of TTX-080, an HLA-G Antagonist, in Subjects with Advanced Solid Tumors.
Primary Objective:
To assess safety and tolerability of increasing dose levels of TTX-080 in successive cohorts of subjects with advanced solid tumors to identify the maximum tolerated dose (MTD) or maximum administered dose and select the recommended Phase 2 dose (RP2D)/schedule.
Secondary Objectives(s):
(1) To characterize the single-dose and/or multiple-dose pharmacokinetics (PK) of TTX-080 following intravenous (IV) administration in subjects with advanced solid tumors.
(2) To evaluate the immunogenicity of TTX-080 in subjects with advanced solid tumors.
(3) To evaluate the preliminary antitumor activity of TTX-080 in subjects with advanced solid tumors.
Exploratory Objective: To assess the effects of TTX-080 on pharmacodynamic biomarkers relating to mechanism of action and immune responses.
Folfiri
Pembrolizumab (MK-3475)
TTX-080
- Rutgers University
Abbreviated 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 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
Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site ClinicalTrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.
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