A Study of ABBV-181 in Participants With Advanced Solid Tumors

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 ]
If a maximum tolerated dose (MTD) is reached, the RPTD of ABBV-181 will not be a dose higher than the defined MTD, and will be selected based on the type(s) and occurrence(s) of dose limiting toxicities which occur in addition to the MTD. If a MTD is not reached, then the RPTD will be defined based on the safety and other available data.
Maximum tolerated dose (MTD) of ABBV-181 [ Time Frame: Up to 6 months ]
MTD will be defined at the highest dose level at which less than 2 of 6 subjects or less than 33% of (if cohort is expanded beyond 6) participants experience a dose limiting toxicity.
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 ]

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 ]
ORR is defined as the proportion of subjects with a confirmed partial or complete response to the treatment.
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 ]
CBR defined as the proportion of subjects with a confirmed partial response (PR), complete response (CR), or stable disease.
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 ]
PFS time is defined as the time from the participant’s first dose of study drug (Day 1) to either the participant’s disease progression or death, whichever occurs first.
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 ]
DOR for a participant is defined as the time from the participant’s initial objective response to study drug therapy to disease progression or death, whichever occurs first.

Eligibility

Inclusion Criteria:: 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.

Exclusion Criteria: 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).