A First-in-human, Phase 1 Study to Evaluate the Safety of TTX-080, an HLA-G Antagonist, in Subjects With Advanced Solid Tumors
- Study HIC#:2000029131
- Last Updated:02/05/2023
This is a Phase 1, multicenter, open-label, multiple-dose, dose-escalation and dose-expansion study to evaluate the safety, tolerability, PK, and pharmacodynamics of TTX-080 monotherapy in subjects with advanced or metastatic solid tumors known to express HLA-G.
This first-in-human (FIH) study has been designed to evaluate the safety, tolerability, and preliminary antitumor activity of TTX-080 as monotherapy in adults with unresectable or metastatic solid tumors known to express HLA-G.
For more information about this study, including how to volunteer, contact:
- Phone Number: 1-203-785-6431
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Trial Purpose and Description
Primary Outcome Measures :
- Recommended Phase 2 Dose (RP2D) [ Time Frame: 1 cycle (each cycle is 21 days) ]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
Abbreviated Inclusion Criteria:
- Subject with histological or cytological 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
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 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