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

NCT03859752 | Suspended Phase 1 FDA Drug

• 1 other identifier: TR1801-CL-01
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 4

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.

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Keywords

antibody-drug conjugate; c-Met; solid tumors; Phase 1

Outcome Measures

Primary Outcomes (2)

• Characterize safety of TR1801-ADC in patients with advanced solid tumor malignancies which express c-Met

  Number of participants with treatment-related adverse events

  4 years

• Establish maximum tolerated dose

  Number of participants with protocol-defined dose-limiting toxicity

  3.5 years

Secondary Outcomes (3)

• Evaluate pharmacokinetics of TR1801-ADC

  4 years

• Immunogenicity

  4 years

• Evaluate clinical activity of TR1801-ADC

  5 years

Study Arms (1)

TR1801-ADC

EXPERIMENTAL

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

Biological: TR1801-ADC

Interventions

TR1801-ADC BIOLOGICAL

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

TR1801-ADC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Open Innovation Partners, Inc.: lead

Study Sites (4)

University of Southern California Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

Location

University of Colorado

Aurora, Colorado, 80045, United States

Location

John Hopkins - Sidney Kimmel Comprehensive Cancer Center

Baltimore, Maryland, 21287, United States

Location

University of Washington / Seattle Cancer Care

Seattle, Washington, 98109, United States

Location

Study Officials

• Gilad Gordon, MD

  Open Innovation Partners

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Open label, multiple dose, dose-escalation

Study Record Dates

• First Submitted: February 26, 2019
• First Posted: March 1, 2019
• Study Start: August 14, 2019
• Primary Completion: July 4, 2023
• Study Completion: December 31, 2023
• Last Updated: September 22, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)