This is an open-label, Phase I, dose-escalation study to determine the recommended Phase 2 dose (RPTD), maximum tolerated dose (MTD), and evaluate the safety and pharmacokinetic (PK) profile of ABBV-181. The study will consist of 2 parts: ABBV-181 dose escalation and ABBV-181 dose expansion.
|First Received Date||December 15, 2016|
|Last Changed Date||March 21, 2017|
|Start Date||December 2016|
|Anticipated Primary Completion Date||June 2018|
|Primary Outcome Measures||
Number of participants with adverse events [Time Frame: From first dose of study drug until 90 days following last dose of study drug (up to 24 months)]
Recommended Phase 2 Dose (RPTD) for ABBV-181 [Time Frame: Up to 6 months]
Maximum tolerated dose (MTD) of ABBV-181 [Time Frame: Up to 6 months]
Maximum observed serum concentration (Cmax) [Time Frame: Up to 12 weeks after participant's first dose]
Time to Cmax (Tmax) [Time Frame: Up to 12 weeks after participant's first dose]
Area under the serum concentration time curve (AUC) [Time Frame: Up to 12 weeks after participant's first dose]
Terminal half-life (t1/2) [Time Frame: Up to 4 weeks after participant's first dose]
|Secondary Outcome Measures||
Objective response rate (ORR) [Time Frame: First dose of study drug through at least 30 days after end of treatment; up to 24-month treatment period]
Clinical benefit rate (CBR, defined as CR, PR or SD) [Time Frame: First dose of study drug through at least 30 days after end of treatment; up to 24-month treatment period]
Progression-free survival (PFS) [Time Frame: First dose of study drug through at least 30 days after end of treatment; up to 24-month treatment period]
Duration of objective response (DOR) [Time Frame: First dose of study drug through at least 30 days after end of treatment; up to 24-month treatment period]
|Study Arms / Comparison Groups||1 / 0|
|Ages||18 Years - 99 Years|
|Accepts Healthy Volunteers||No|
- Participant must have an advanced solid tumor and must not be a candidate for surgical resection or other approved therapeutic regimen known to provide clinical benefit. For dose escalation, the participant may have been previously treated with a programmed cell death 1 (PD-I) targeting agent. For dose expansion, the participant must be PD-I/PD-L1 targeting agent naïve.
- Participant has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2.
- Participants have adequate bone marrow, renal, hepatic and coagulation function.
- Participants must have measurable or evaluable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 in the dose escalation portion of the trial. Participants in the expansion cohort must have measurable disease per RECIST version 1.1 or disease evaluable by assessment of tumor antigens.
- Participant has received anticancer therapy including chemotherapy, immunotherapy, radiation therapy, biologic, herbal therapy, or any investigational therapy within a period of 21 days, prior to the first dose of ABBV-181.
- Participant has unresolved adverse events greater than or equal to grade 1 from prior anticancer therapy except for alopecia.
- Current or prior use of immunosuppressive medication within 14 days prior to the first dose (with certain exceptions).
- History of primary immunodeficiency, bone marrow transplantation, chronic lymphocytic leukemia, solid organ transplantation, or previous clinical diagnosis of tuberculosis.
- Confirmed positive test results for human immunodeficiency virus (HIV), or participants with chronic or active hepatitis B or C.
- Participant has known history or inflammatory bowel disease, pneumonitis, or known uncontrolled metastases to the central nervous system (CNS) (with certain exceptions).
|Verification Date||March 2017|