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

Unspecified Adult Solid Tumor, Protocol Specific Clinical Trial

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT03859752
• Other study ID #: TR1801-CL-01
• Status: Suspended
• Phase: Phase 1
• Start date: August 14, 2019
• Est. completion date: December 31, 2023

Study information

• Verified date: July 2023
• Source: Open Innovation Partners, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 15
• Est. completion date: December 31, 2023
• Est. primary completion date: July 4, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neoplasms
• Unspecified Adult Solid Tumor, Protocol Specific

Intervention

Biological:
• TR1801-ADC
Humanized anti-c-Met monoclonal antibody conjugated to a cleavable pyrrolobenzodiazepine toxin

Locations

Country	Name	City	State
United States	University of Colorado	Aurora	Colorado
United States	John Hopkins - Sidney Kimmel Comprehensive Cancer Center	Baltimore	Maryland
United States	University of Southern California Norris Comprehensive Cancer Center	Los Angeles	California
United States	University of Washington / Seattle Cancer Care	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Open Innovation Partners, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Establish maximum tolerated dose	Number of participants with protocol-defined dose-limiting toxicity	3.5 years
Secondary	Evaluate pharmacokinetics of TR1801-ADC	Analyze blood plasma concentrations	4 years
Secondary	Immunogenicity	Assess anti-drug antibodies of TR1801-ADC	4 years
Secondary	Evaluate clinical activity of TR1801-ADC	Assess objective response rate in accordance with Response Evaluation Criteria in Solid Tumors (RECIST V1.1)	5 years