Clinical trial NCT03859752: TR1801-ADC in Patients With Tumors That Express c-Met
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
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: PHASE1
Conditions: Unspecified Adult Solid Tumor, Protocol Specific
Keywords: antibody-drug conjugate
c-Met
solid tumors
Phase 1
Lead sponsor: Open Innovation Partners, Inc.
Sponsor class: INDUSTRY
First posted: 2019-03-01
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Open label, multiple dose, dose-escalation
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Characterize safety of TR1801-ADC in patients with advanced solid tumor malignancies which express c-Met
timeFrame: 4 years
measure: Establish maximum tolerated dose
timeFrame: 3.5 years
Secondary outcomes:
measure: Evaluate pharmacokinetics of TR1801-ADC
timeFrame: 4 years
measure: Immunogenicity
timeFrame: 4 years
measure: Evaluate clinical activity of TR1801-ADC
timeFrame: 5 years
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of Southern California Norris Comprehensive Cancer Center
state: California
city: Aurora
country: United States
facility: University of Colorado
state: Colorado
city: Baltimore
country: United States
facility: John Hopkins - Sidney Kimmel Comprehensive Cancer Center
state: Maryland
city: Seattle
country: United States
facility: University of Washington / Seattle Cancer Care
state: Washington
Study officials:
affiliation: Open Innovation Partners
name: Gilad Gordon, MD
role: STUDY_DIRECTOR
References: