Description:
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.
Title
- Brief Title: 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
Clinical Trial IDs
- ORG STUDY ID:
TR1801-CL-01
- NCT ID:
NCT03859752
Conditions
- Unspecified Adult Solid Tumor, Protocol Specific
Interventions
Drug | Synonyms | Arms |
---|
TR1801-ADC | | TR1801-ADC |
Purpose
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.
Trial Arms
Name | Type | Description | Interventions |
---|
TR1801-ADC | Experimental | Humanized anti-c-Met monoclonal antibody conjugated to a cleavable pyrrolobenzodiazepine toxin | |
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
- Untreated or uncontrolled bacterial, viral or fungal infection
- HIV infection or active infection with hepatitis B or C
- Prior treatment with a c-Met targeted agent
- Prior hypersensitivity reaction to treatment with another monoclonal antibody
- QTcF >=470 ms
- Administration of a live, attenuated vaccine within 28 days before the first dose of
study treatment
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Characterize safety of TR1801-ADC in patients with advanced solid tumor malignancies which express c-Met |
Time Frame: | 2 years |
Safety Issue: | |
Description: | Number of participants with treatment-related adverse events |
Secondary Outcome Measures
Measure: | Evaluate pharmacokinetics of TR1801-ADC |
Time Frame: | 2 years |
Safety Issue: | |
Description: | Analyze blood plasma concentrations |
Measure: | Immunogenicity |
Time Frame: | 2 years |
Safety Issue: | |
Description: | Assess anti-drug antibodies of TR1801-ADC |
Measure: | Evaluate clinical activity of TR1801-ADC |
Time Frame: | 3 years |
Safety Issue: | |
Description: | Assess objective response rate in accordance with Response Evaluation Criteria in Solid Tumors (RECIST V1.1) |
Details
Phase: | Phase 1 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Tanabe Research Laboratories USA Inc |
Trial Keywords
- antibody-drug conjugate
- c-Met
- solid tumors
- Phase 1
Last Updated
July 6, 2021