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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 (TR1801-CL-01)
Protocol Number:
J1917
Phase:
Phase I
Physician:
Kristen Marrone
Sites:
Johns Hopkins Kimmel Cancer Center in Baltimore
Purpose:
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:
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 contraceptionExclusion 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 less than 2 weeks•Unresolved adverse events greater than equal to 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 greater than equal to 470 ms
Treatment:
TR1801 will be given via iv infusion by central or peripheral IV once every 3 weeks.
Population:
Adult
Last Update
08/08/2020 05:02 AM