TR1801-ADC in Patients With Tumors That Express c-Met

Paused · Phase 1

Conditions studied: Unspecified Adult Solid Tumor, Protocol Specific

In brief

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.

Key facts

Study ID

NCT03859752

Run by

Open Innovation Partners, Inc.

People needed

15

Starts

2019-08-14

Expected to finish

2023-12-31

Last updated by the study team

2023-09-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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