Description:
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 is
completed.
Title
- Brief Title: A Study of ABT-165 in Subjects With Solid Tumors
- Official Title: A Multicenter, Phase 1/1b, Open-Label, Dose-Escalation Study of ABT-165, a Dual Variable Domain Immunoglobulin in Subjects With Advanced Solid Tumors
Clinical Trial IDs
- ORG STUDY ID:
M14-006
- NCT ID:
NCT01946074
Conditions
Interventions
Drug | Synonyms | Arms |
---|
paclitaxel | | Cohort A |
FOLFIRI | | Cohort B |
ABT-165 | | Cohort A |
ABBV-181 | | Cohort C |
Purpose
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 is
completed.
Trial Arms
Name | Type | Description | Interventions |
---|
Monotherapy | Experimental | ABT-165 will be administered at escalating dose levels in 28-day dosing cycles (2 doses per cycle). Additional subjects will be enrolled in an expansion cohort that will further evaluate ABT-165 | |
Cohort A | Experimental | ABT-165 plus paclitaxel | |
Cohort B | Experimental | ABT-165 plus FOLFIRI | |
Cohort C | Experimental | ABT-165 plus ABBV-181 | |
Cohort D | Experimental | ABT-165 plus ABBV-181 plus paclitaxel | - paclitaxel
- ABT-165
- ABBV-181
|
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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 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.
Maximum Eligible Age: | 99 Years |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Clinical lab testing |
Time Frame: | Up to 30 days after a 24-month treatment period |
Safety Issue: | |
Description: | Hematology, Chemistry, and Urinalysis |
Secondary Outcome Measures
Measure: | Duration of overall response (DOR) |
Time Frame: | Up to 30 days after a 24-month treatment period |
Safety Issue: | |
Description: | DOR is defined as the time from the subject's initial CR or PR to the time of disease progression |
Measure: | Objective response rate (ORR) |
Time Frame: | Up to 30 days after a 24-month treatment period |
Safety Issue: | |
Description: | ORR is defined as the proportion of the subjects who have a complete response (CR) or partial response (PR) |
Measure: | Progression free survival (PFS) |
Time Frame: | Up to 30 days after a 24-month treatment period |
Safety Issue: | |
Description: | PFS is defined as the time from the first dose date of ABT-165 to either disease progression or death, whichever occurs first |
Details
Phase: | Phase 1 |
Primary Purpose: | Interventional |
Overall Status: | Active, not recruiting |
Lead Sponsor: | AbbVie |
Trial Keywords
- ABBV-181
- ABT-165
- cancer
- neoplasm
- advanced solid tumor
- colorectal cancer
Last Updated
May 6, 2021