First-in-human, Phase 1 study to assess safety, tolerability, and pharmacokinetics of TR1801-ADC in patients with select solid tumors that express c-Met.
First-in-human, Phase 1, multiple dose-dose escalation study designed to determine safety, tolerability, maximum tolerated dose, and recommended phase 2 dose of TR1801-ADC in patients with select solid tumors that express c-Met. This study will also assess pharmacokinetics (PK), anti-tumor activity, and correlation between clinical outcomes (safety, anti-tumor activity, and PK) and c-Met expression.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
Humanized anti-c-Met monoclonal antibody conjugated to a cleavable pyrrolobenzodiazepine toxin
University of Southern California Norris Comprehensive Cancer Center
Los Angeles, California, United States
University of Colorado
Aurora, Colorado, United States
John Hopkins - Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, United States
University of Washington / Seattle Cancer Care
Seattle, Washington, United States
Characterize safety of TR1801-ADC in patients with advanced solid tumor malignancies which express c-Met
Number of participants with treatment-related adverse events
Time frame: 4 years
Establish maximum tolerated dose
Number of participants with protocol-defined dose-limiting toxicity
Time frame: 3.5 years
Evaluate pharmacokinetics of TR1801-ADC
Analyze blood plasma concentrations
Time frame: 4 years
Immunogenicity
Assess anti-drug antibodies of TR1801-ADC
Time frame: 4 years
Evaluate clinical activity of TR1801-ADC
Assess objective response rate in accordance with Response Evaluation Criteria in Solid Tumors (RECIST V1.1)
Time frame: 5 years
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