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.
    
              
             
           
        
      
        
          
      
        
          
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
| Drug | Synonyms | Arms | 
|---|
| TR1801-ADC |  | TR1801-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
| Name | Type | Description | Interventions | 
|---|
| TR1801-ADC | Experimental | Humanized anti-c-Met monoclonal antibody conjugated to a cleavable pyrrolobenzodiazepine toxin |  | 
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
          -  Administration of a live, attenuated vaccine within 28 days before the first dose of
             study treatment
      | 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
 
Last Updated
July 6, 2021