Status:
SUSPENDED
TR1801-ADC in Patients With Tumors That Express c-Met
Lead Sponsor:
Open Innovation Partners, Inc.
Conditions:
Unspecified Adult Solid Tumor, Protocol Specific
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 soli...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 14 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2023
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT03859752
Start Date
August 14 2019
End Date
December 31 2023
Last Update
September 22 2023
Active Locations (4)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Southern California Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
2
University of Colorado
Aurora, Colorado, United States, 80045
3
John Hopkins - Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, United States, 21287
4
University of Washington / Seattle Cancer Care
Seattle, Washington, United States, 98109