TR1801-ADC in Patients With Tumors That Express c-Met
Trial Status: temporarily closed to accrual
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.
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Additional locations may be listed on ClinicalTrials.gov for NCT03859752.
Locations matching your search criteria
United States
Maryland
Baltimore
Johns Hopkins University/Sidney Kimmel Cancer Center
Status: Active
Name Not AvailableFirst-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.
Trial PhasePhase I
Trial Typetreatment
Lead OrganizationOpen Innovation Partners, Inc.
- Primary IDTR1801-CL-01
- Secondary IDsNCI-2019-01723
- ClinicalTrials.gov IDNCT03859752