A Phase I Study to Evaluate the Safety and Pharmacokinetics of ABBV-399 in Japanese Subjects With Advanced Solid Tumors
Overview
- Phase
- Phase 1
- Intervention
- ABBV-399
- Conditions
- Advanced Solid Tumors Cancer
- Sponsor
- AbbVie
- Enrollment
- 9
- Locations
- 2
- Primary Endpoint
- Area under the curve (AUC) from time zero to the last measurable concentration AUC (0-t)
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
An open-label, dose-escalation study designed to evaluate the safety, pharmacokinetics, and preliminary efficacy of ABBV-399 in participants with advanced solid tumors.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Participant with histologically confirmed advanced solid tumor.
- •Participant must have advanced solid tumor that is not amenable to surgical resection or other approved therapeutic options that have demonstrated clinical benefit.
- •Participant has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to
- •Participant must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.
- •Participant has archived diagnostic formalin-fixed paraffin embedded (FFPE) tumor tissue available for analysis.
- •Participant has adequate bone marrow, renal, and hepatic function.
Exclusion Criteria
- •Participant has received anticancer therapy including chemotherapy, immunotherapy, radiation therapy, immunotherapy, biologic, or any investigational therapy within a period of 21 days, or herbal therapy within 7 days prior to the first dose of ABBV-
- •Participant has known uncontrolled metastases to the central nervous system. Participants with brain metastases are eligible after definitive therapy provided they are asymptomatic off systemic steroids and anticonvulsants for at least 2 weeks prior to first dose of ABBV-
- •Participant has unresolved clinically significant adverse events \>= Grade 2 from prior anticancer therapy except for alopecia or anemia.
- •Participant has had major surgery within 21 days prior to the first dose of ABBV-399.
Arms & Interventions
ABBV-399
ABBV-399 via intravenous administration at escalating dose levels.
Intervention: ABBV-399
Outcomes
Primary Outcomes
Area under the curve (AUC) from time zero to the last measurable concentration AUC (0-t)
Time Frame: Up to 24 months
AUC (0-t) is defined as area under the concentration versus time curve from time zero (pre-dose) to the time of the last measurable concentration.
Maximum Tolerated Dose (MTD) or maximally administered dose (MAD) for ABBV-399
Time Frame: Up to 21 days
MTD/MAD is defined as the highest dose level at which less than 2 of 6 (or \< 33% if cohort is expanded beyond 6) participants experience a dose limiting toxicity.
Terminal elimination half life (t1/2)
Time Frame: Up to 24 months
Terminal elimination half life (t1/2)
Time to Cmax (Tmax)
Time Frame: Up to 24 months
Time to Cmax (Tmax)
Maximum Observed Concentration (Cmax)
Time Frame: Up to 24 months
Maximum observed concentration (Cmax)
Secondary Outcomes
- Duration of response (DOR)(Up to 24 months)
- Progression-Free Survival (PFS) Time(Up to 24 months)
- Objective Response Rate (ORR)(Up to 24 months)