Study of ABT-165 in Subjects With Advanced Solid Tumors
Trial ID or NCT#
This is a Phase 1/1b open-label study evaluating the safety, pharmacokinetics (PK), and preliminary efficacy of ABT-165 in subjects with advanced solid tumors. The early clinical development plan for ABT-165 is based on the activity demonstrated in preclinical models.
A Multicenter, Phase 1/1b, Open-Label, Dose-Escalation Study of ABT-165, a Dual Variable Domain Immunoglobulin in Subjects With Advanced Solid Tumors
- - Subject must have advanced solid tumor that is not amenable to surgical resection or other approved therapeutic options that have demonstrated clinical benefit.
- - Subject has adequate bone marrow, renal, hepatic and coagulation function.
- - Subject must have measurable disease per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 or disease evaluable by assessment of tumor antigens including but not limited to cancer antigen (CA-125) and prostate-specific antigen (PSA).
- - Women of childbearing potential must have a negative serum pregnancy test within 14 days prior to initiation of treatment. Female subject considered not of childbearing potential must be documented as being surgically sterile or post-menopausal for at least 1 year. Women of childbearing potential and men must agree to use adequate contraception.
- - Subjects in the combination therapy cohorts must meet the above inclusion criteria and be eligible to receive paclitaxel or FOLFIRI per most current prescribing information, or at the discretion of the Investigator.
- - Subject has received anticancer therapy including chemotherapy, radiation therapy, immunotherapy, biologic, or any investigational therapy within a period of 21 days or anti-cancer herbal therapy within 7 days prior to Cycle 1 Day 1 of ABT-165.
- - Subject has uncontrolled metastases to the central nervous system (CNS).
- - Subject has unresolved clinically significant toxicities from prior anticancer therapy, defined as any Common Terminology Criteria for Adverse Events (CTCAE) Grade 2 or higher.
- - Subject has history (within previous 5 years) of clinically significant pulmonary hypertension, uncontrolled systemic hypertension, hypertensive crisis, congestive heart failure, myocardial infarction, aneurysm or aneurysm repair or the left ventricular ejection fraction (LVEF) less than or equal to 50%.
- - Subjects enrolled on the combination therapy phase must not meet the above exclusion criteria and must be eligible to receive paclitaxel or FOLFIRI per most current prescribing information, or at the discretion of the Investigator.
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