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

Sponsor
Tanabe Research Laboratories USA Inc (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT03859752
Collaborator
Open Innovation Partners (Other)
40
Enrollment
5
Locations
1
Arm
43.5
Anticipated Duration (Months)
8
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study 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.

Condition or Disease Intervention/Treatment Phase
  • 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Open label, multiple dose, dose-escalationOpen 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
Actual Study Start Date :
Aug 14, 2019
Anticipated Primary Completion Date :
Mar 31, 2023
Anticipated Study Completion Date :
Mar 31, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Characterize safety of TR1801-ADC in patients with advanced solid tumor malignancies which express c-Met [2 years]

    Number of participants with treatment-related adverse events

  2. Establish maximum tolerated dose [1.5 years]

    Number of participants with protocol-defined dose-limiting toxicity

Secondary Outcome Measures

  1. Evaluate pharmacokinetics of TR1801-ADC [2 years]

    Analyze blood plasma concentrations

  2. Immunogenicity [2 years]

    Assess anti-drug antibodies of TR1801-ADC

  3. Evaluate clinical activity of TR1801-ADC [3 years]

    Assess objective response rate in accordance with Response Evaluation Criteria in Solid Tumors (RECIST V1.1)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
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

  • Administration of a live, attenuated vaccine within 28 days before the first dose of study treatment

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Southern California Norris Comprehensive Cancer Center Los Angeles California United States 90033
2 Hoag Memorial Hospital Presbyterian Newport Beach California United States 92663
3 University of Colorado Aurora Colorado United States 80045
4 John Hopkins - Sidney Kimmel Comprehensive Cancer Center Baltimore Maryland United States 21287
5 University of Washington / Seattle Cancer Care Seattle Washington United States 98109

Sponsors and Collaborators

  • Tanabe Research Laboratories USA Inc
  • Open Innovation Partners

Investigators

  • Study Director: Gilad Gordon, MD, Tanabe Research Lab

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Tanabe Research Laboratories USA Inc
ClinicalTrials.gov Identifier:
NCT03859752
Other Study ID Numbers:
  • TR1801-CL-01
First Posted:
Mar 1, 2019
Last Update Posted:
Jul 12, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
c-Met
solid tumors
Phase 1
Additional relevant MeSH terms:
Neoplasms

Study Results

No Results Posted as of Jul 12, 2022