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

NCT ID: NCT03859752

Last Updated: 2023-09-22

Basic Information

• Recruitment Status: SUSPENDED
• Clinical Phase: PHASE1
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-14
• Study Completion Date: 2023-12-31

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.

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

TR1801-ADC

Humanized anti-c-Met monoclonal antibody conjugated to a cleavable pyrrolobenzodiazepine toxin

Group Type: EXPERIMENTAL

TR1801-ADC

Intervention Type: BIOLOGICAL

Humanized anti-c-Met monoclonal antibody conjugated to a cleavable pyrrolobenzodiazepine toxin

Interventions

TR1801-ADC

Humanized anti-c-Met monoclonal antibody conjugated to a cleavable pyrrolobenzodiazepine toxin

Intervention Type: BIOLOGICAL

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
• History of capillary leak syndrome
• Corticosteroid intolerance
• History of anasarca
• Untreated or uncontrolled bacterial, viral or fungal infection
• HIV infection or active infection with hepatitis B or C
• Significant liver disease
• History of alcoholism or current alcoholism
• Signs of significant portal hypertension
• Significant kidney disease within 2 years
• Active or unstable gallstone disease
• Prior treatment with a c-Met targeted agent
• Prior hypersensitivity reaction to treatment with another monoclonal antibody
• QTcF >=470 ms
• Patients may not start any new herbal or dietary supplement within 4 weeks before initiation of study treatment nor while receiving study treatment
• Administration of a live, attenuated vaccine within 28 days before the first dose of study treatment

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Open Innovation Partners, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gilad Gordon, MD

Role: STUDY_DIRECTOR

Open Innovation Partners

Locations

University of Southern California Norris Comprehensive Cancer Center

Los Angeles, California, United States

University of Colorado

Aurora, Colorado, United States

John Hopkins - Sidney Kimmel Comprehensive Cancer Center

Baltimore, Maryland, United States

University of Washington / Seattle Cancer Care

Seattle, Washington, United States

Countries

United States

Other Identifiers

TR1801-CL-01

Identifier Type: -

Identifier Source: org_study_id