TR1801-ADC in Patients With Tumors That Express c-Met
- Conditions
- Unspecified Adult Solid Tumor, Protocol Specific
- Interventions
- Biological: TR1801-ADC
- Registration Number
- NCT03859752
- Lead Sponsor
- Open Innovation Partners, Inc.
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- SUSPENDED
- Sex
- All
- Target Recruitment
- 15
- Compliance with all study procedures and visits to the clinical research site
- Locally advanced or metastatic disease that is not amenable to definitive therapy
- Histologically confirmed diagnosis of a solid tumor which expresses c-Met
- Must have progressed or have been intolerant to all available therapies known to confer clinical benefit appropriate for the patient's tumor type
- Measurable baseline disease as defined by RECIST Version 1.1
- ECOG Performance Status 0-1
- Body weight within 40 and 150 kg
- Clinical laboratory values with the limits as defined by the protocol
- Not pregnant or breast feeding
- Males and women of child-bearing potential must agree to use an effective method of contraception
- Any disease or condition that may be considered to pose an increased risk from study treatment or the ability of the patient to participate and comply with study procedures
- Treatment with anti-cancer therapy (including cytotoxic chemotherapy, major surgery, radiation, biologic and investigational agents) within 21 days before first dose of study treatment
- Brain metastases that has not stabilized for at least 28 days after therapy and who have discontinued steroids for <2 weeks
- Unresolved adverse events >= Grade 2 from prior anticancer therapies
- Acute myocardial infarction, cerebral ischemic infarct, or other arterial thrombosis within 6 months of screening for this study.
- Uncontrolled hypertension, unstable angina, or NYHA Class III/IV heart failure
- History of capillary leak syndrome
- Corticosteroid intolerance
- History of anasarca
- Untreated or uncontrolled bacterial, viral or fungal infection
- HIV infection or active infection with hepatitis B or C
- Significant liver disease
- History of alcoholism or current alcoholism
- Signs of significant portal hypertension
- Significant kidney disease within 2 years
- Active or unstable gallstone disease
- Prior treatment with a c-Met targeted agent
- Prior hypersensitivity reaction to treatment with another monoclonal antibody
- QTcF >=470 ms
- Patients may not start any new herbal or dietary supplement within 4 weeks before initiation of study treatment nor while receiving study treatment
- Administration of a live, attenuated vaccine within 28 days before the first dose of study treatment
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description TR1801-ADC TR1801-ADC Humanized anti-c-Met monoclonal antibody conjugated to a cleavable pyrrolobenzodiazepine toxin
- Primary Outcome Measures
Name Time Method Establish maximum tolerated dose 3.5 years Number of participants with protocol-defined dose-limiting toxicity
Characterize safety of TR1801-ADC in patients with advanced solid tumor malignancies which express c-Met 4 years Number of participants with treatment-related adverse events
- Secondary Outcome Measures
Name Time Method Evaluate clinical activity of TR1801-ADC 5 years Assess objective response rate in accordance with Response Evaluation Criteria in Solid Tumors (RECIST V1.1)
Evaluate pharmacokinetics of TR1801-ADC 4 years Analyze blood plasma concentrations
Immunogenicity 4 years Assess anti-drug antibodies of TR1801-ADC
Trial Locations
- Locations (4)
John Hopkins - Sidney Kimmel Comprehensive Cancer Center
🇺🇸Baltimore, Maryland, United States
University of Colorado
🇺🇸Aurora, Colorado, United States
University of Washington / Seattle Cancer Care
🇺🇸Seattle, Washington, United States
University of Southern California Norris Comprehensive Cancer Center
🇺🇸Los Angeles, California, United States