Clinical Trials /

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

NCT03859752

Description:

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.

Related Conditions:
  • Malignant Solid Tumor
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: TR1801-ADC in Patients With Tumors That Express c-Met
  • Official Title: 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

Clinical Trial IDs

  • ORG STUDY ID: TR1801-CL-01
  • NCT ID: NCT03859752

Conditions

  • Unspecified Adult Solid Tumor, Protocol Specific

Interventions

DrugSynonymsArms
TR1801-ADCTR1801-ADC

Purpose

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.
    

Trial Arms

NameTypeDescriptionInterventions
TR1801-ADCExperimentalHumanized anti-c-Met monoclonal antibody conjugated to a cleavable pyrrolobenzodiazepine toxin
  • TR1801-ADC

Eligibility Criteria

        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

          -  Untreated or uncontrolled bacterial, viral or fungal infection

          -  HIV infection or active infection with hepatitis B or C

          -  Prior treatment with a c-Met targeted agent

          -  Prior hypersensitivity reaction to treatment with another monoclonal antibody

          -  QTcF >=470 ms
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Characterize safety of TR1801-ADC in patients with advanced solid tumor malignancies which express c-Met
Time Frame:2 years
Safety Issue:
Description:Number of participants with treatment-related adverse events

Secondary Outcome Measures

Measure:Evaluate pharmacokinetics of TR1801-ADC
Time Frame:2 years
Safety Issue:
Description:Analyze blood plasma concentrations
Measure:Immunogenicity
Time Frame:2 years
Safety Issue:
Description:Assess anti-drug antibodies of TR1801-ADC
Measure:Evaluate clinical activity of TR1801-ADC
Time Frame:3 years
Safety Issue:
Description:Assess objective response rate in accordance with Response Evaluation Criteria in Solid Tumors (RECIST V1.1)

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Tanabe Research Laboratories USA Inc

Trial Keywords

  • antibody-drug conjugate
  • c-Met
  • solid tumors
  • Phase 1

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