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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03859752
Recruitment Status : Not yet recruiting
First Posted : March 1, 2019
Last Update Posted : March 4, 2019
Open Innovation Partners
Information provided by (Responsible Party):
Tanabe Research Laboratories USA Inc

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.

Condition or disease Intervention/treatment Phase
Unspecified Adult Solid Tumor, Protocol Specific Biological: TR1801-ADC Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Open label, multiple dose, dose-escalation
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Study Start Date : March 1, 2019
Estimated Primary Completion Date : March 1, 2023
Estimated Study Completion Date : March 1, 2023

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: TR1801-ADC
Humanized anti-c-Met monoclonal antibody conjugated to a cleavable pyrrolobenzodiazepine toxin
Biological: TR1801-ADC
Humanized anti-c-Met monoclonal antibody conjugated to a cleavable pyrrolobenzodiazepine toxin

Primary Outcome Measures :
  1. 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

  2. Establish maximum tolerated dose [ Time Frame: 1 year ]
    Number of participants with protocol-defined dose-limiting toxicity

Secondary Outcome Measures :
  1. Evaluate pharmacokinetics of TR1801-ADC [ Time Frame: 2 years ]
    Analyze blood plasma concentrations

  2. Immunogenicity [ Time Frame: 2 years ]
    Assess anti-drug antibodies of TR1801-ADC

  3. 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)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03859752

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Contact: Nicole Herdener (919) 972-7168
Contact: Brittany Hagen, MSN, OCN (614) 721-1740

Sponsors and Collaborators
Tanabe Research Laboratories USA Inc
Open Innovation Partners
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Study Director: Wendy J Levin, MD, MS Tanabe Research Laboratories

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Responsible Party: Tanabe Research Laboratories USA Inc Identifier: NCT03859752     History of Changes
Other Study ID Numbers: TR1801-CL-01
First Posted: March 1, 2019    Key Record Dates
Last Update Posted: March 4, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Tanabe Research Laboratories USA Inc:
antibody-drug conjugate
solid tumors
Phase 1

Additional relevant MeSH terms:
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Immunologic Factors
Physiological Effects of Drugs