drugset / Trial / NCT03986606

A Study of PSB205 in Subjects With Advanced Solid Tumors

NCT03986606

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

EvaluationDrugModalityDoseRoute
Subject QL1706 Monoclonal antibody Intravenous

Indications