Trial Search Results
A Study of ABT-165 in Subjects With Solid Tumors
This is a Phase 1/1b open-label study evaluating the safety, pharmacokinetics (PK), and preliminary efficacy of ABT-165 when administered as monotherapy and in combination with paclitaxel or 5-fluoruracil, folinic acid and irinotecan (FOLFIRI) or ABBV-181 with/without paclitaxel in subjects with advanced solid tumors. Enrollment to Cohorts A, B, C and D were completed.
Stanford is currently not accepting patients for this trial.
- Drug: paclitaxel
- Drug: FOLFIRI
- Drug: ABT-165
- Drug: ABBV-181
- 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 at the
screening visit and a negative urine pregnancy test at baseline prior to the first
dose of study drug. 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. Subjects in the combination therapy cohorts
who are to receive ABBV-181, an anti-PD1 antibody, must also meet other criteria
described in the Protocol.
- 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
- Subject has history (within previous 5 years) of clinically significant pulmonary
hypertension, uncontrolled systemic hypertension or hypertensive crisis, symptomatic
heart failure, cardiomyopathy, myocardial infarction, unstable/severe angina pectoris,
cardiac arrhythmia requiring medication, coronary/peripheral artery bypass graft,
aneurysm or aneurysm repair, angioplasty, cerebrovascular accident, transient ischemic
attack or the left ventricular ejection fraction (LVEF) less than 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. Subjects receiving
ABBV-181 must not meet other exclusion criteria described in the Protocol.
Ages Eligible for Study
18 Years - 99 Years
Genders Eligible for Study