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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03859752
Recruitment Status : Active, not recruiting
First Posted : March 1, 2019
Last Update Posted : October 12, 2021
Sponsor:
Collaborator:
Open Innovation Partners
Information provided by (Responsible Party):
Tanabe Research Laboratories USA Inc

Tracking Information
First Submitted Date  ICMJE February 26, 2019
First Posted Date  ICMJE March 1, 2019
Last Update Posted Date October 12, 2021
Actual Study Start Date  ICMJE August 14, 2019
Estimated Primary Completion Date March 31, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 6, 2020)
  • Characterize safety of TR1801-ADC in patients with advanced solid tumor malignancies which express c-Met [ Time Frame: 2 years ]
    Number of participants with treatment-related adverse events
  • Establish maximum tolerated dose [ Time Frame: 1.5 years ]
    Number of participants with protocol-defined dose-limiting toxicity
Original Primary Outcome Measures  ICMJE
 (submitted: February 27, 2019)
  • Characterize safety of TR1801-ADC in patients with advanced solid tumor malignancies which express c-Met [ Time Frame: 2 years ]
    Number of participants with treatment-related adverse events
  • Establish maximum tolerated dose [ Time Frame: 1 year ]
    Number of participants with protocol-defined dose-limiting toxicity
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 27, 2019)
  • Evaluate pharmacokinetics of TR1801-ADC [ Time Frame: 2 years ]
    Analyze blood plasma concentrations
  • Immunogenicity [ Time Frame: 2 years ]
    Assess anti-drug antibodies of TR1801-ADC
  • Evaluate clinical activity of TR1801-ADC [ Time Frame: 3 years ]
    Assess objective response rate in accordance with Response Evaluation Criteria in Solid Tumors (RECIST V1.1)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE TR1801-ADC in Patients With Tumors That Express c-Met
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
Open label, multiple dose, dose-escalation
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Unspecified Adult Solid Tumor, Protocol Specific
Intervention  ICMJE Biological: TR1801-ADC
Humanized anti-c-Met monoclonal antibody conjugated to a cleavable pyrrolobenzodiazepine toxin
Study Arms  ICMJE Experimental: TR1801-ADC
Humanized anti-c-Met monoclonal antibody conjugated to a cleavable pyrrolobenzodiazepine toxin
Intervention: Biological: TR1801-ADC
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: February 27, 2019)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 31, 2023
Estimated Primary Completion Date March 31, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03859752
Other Study ID Numbers  ICMJE TR1801-CL-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Tanabe Research Laboratories USA Inc
Study Sponsor  ICMJE Tanabe Research Laboratories USA Inc
Collaborators  ICMJE Open Innovation Partners
Investigators  ICMJE
Study Director: Gilad Gordon, MD Tanabe Research Lab
PRS Account Tanabe Research Laboratories USA Inc
Verification Date April 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP