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

Open Innovation Partners

Status and phase

Suspended

Phase 1

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Treatments

Biological: TR1801-ADC

Study type

Interventional

Funder types

Industry

Other

Identifiers

NCT03859752

TR1801-CL-01

Details and patient eligibility

About

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.

Full 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.

Enrollment

15 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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