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A Phase 1, Open Label, First-in-human Study of TR1801-ADC, an Antibody Drug Conjugate (ADC), in Patients With Select Solid Tumors Expressing c-Met

Description

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.

Phase

N/A

Inclusion and Exclusion 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

  • 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

Sites

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