NCT03986606

A Study of PSB205 in Subjects With Advanced Solid Tumors

A Phase 1, Open-Label, Dose Escalation and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumor Activity of PSB205 in Patients With Relapsed/Refractory Solid Tumors

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 64 (estimated)
• Sponsor: Qilu Puget Sound Biotherapeutics (dba Sound Biologics) · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Neoplasm Malignant

Interventions

Type	Name	Description
BIOLOGICAL	PSB205	PSB205 is a bi-functional product that has been engineered to contain two unique monoclonal antibodies.

Timeline

• Start date: 2019-07-05
• Primary completion: 2021-02-28
• Completion: 2021-07-28
• First posted: 2019-06-14
• Last updated: 2020-11-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study