drugset / Trial / NCT03071757
A Study of the Safety, Tolerability and Pharmacokinetics of ABBV-368 as a Single Agent and Combination in Subjects With Locally Advanced or Metastatic Solid Tumors
Non-randomizedParallel-groupOpen-labelTreatment
Summary
The primary purpose of this Phase 1, open-label study is to evaluate the safety, pharmacokinetics, and preliminary efficacy of ABBV-368 as a monotherapy and in combination with ABBV-181 in participants with locally advanced or metastatic solid tumors. The study will consist of 3 parts: ABBV-368 dose escalation, ABBV-368 tumor-specific dose expansion (triple negative breast cancer \[TNBC\] cohort and head and neck cancer cohort) and 18F-AraG Imaging Substudy.
Timeline
- Start
- 2017-03-21
- Primary completion
- 2022-04-13
- Completion
- 2022-04-13
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | REVDOFILIMAB | Monoclonal antibody | — | Intravenous |
| Background | Budigalimab | Monoclonal antibody | — | Intravenous |
Indications
No indication recorded.