drugset / Trial / NCT03986606
A Study of PSB205 in Subjects With Advanced Solid Tumors
Phase 1
Unknown
64 enrolled
Qilu Puget Sound Biotherapeutics (dba Sound Biologics)
Pharmaceutical Research Associates · collab
NaSequentialOpen-labelTreatment
Summary
This is an open-label, multicenter, Phase 1, ascending dose escalation study of PSB205 in subjects with advanced solid tumors. The study will be conducted in 2 parts. Part 1 of the study will be a dose escalation evaluation to determine the maximum tolerated dose (MTD) and to establish a recommended Phase 2 dose (RP2D) of PSB205. This study purpose is to describe the safety and tolerability, to assess Pharmacokinetics (PK) and immunogenicity, and to preliminarily assess the anti-tumor activity of PSB205 in subjects with solid tumors. Part 2 of the study will further evaluate the RP2D in 3 distinct tumor cohorts of approximately 12 subjects each.
Timeline
- Start
- 2019-07-05
- Primary completion
- 2021-02-28
- Completion
- 2021-07-28
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | QL1706 | Monoclonal antibody | — | Intravenous |