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Part 1 (Dose escalation): PSB205 will be administered in sequential cohorts of 3 to 6 subjects each receiving 1 of 5 doses of PSB205 on day 1 of every 21-day cycle (3 weeks) via IV infusion using a standard 3+3 dose escalation design. Dose escalation will continue until an MTD is reached.

Part 2 (Dose Expansion): The clinical anti-tumor effects of PSB205 will be tested at the recommended Phase 2 dose (RP2D) determined during the dose-escalation phase in subjects from three different solid tumor cohorts.

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

PSB205

Cynthia Erdman

Jelle Kijilstra, M.D, MPH

Anthony Tolcher, MD

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.

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

Safety and tolerability, as defined by the rate of treatment-related adverse events as assessed by NCI CTCAE v5.0.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Study of PSB205 in Subjects With Advanced Solid Tumors	NCT03986606	Neoplasm Malign...	PSB205	18 Years -	Qilu Puget Sound Biotherapeutics (dba Sound Biologics)
A Study of PSB205 in Subjects With Advanced Solid Tumors	NCT03986606	Neoplasm Malign...	PSB205	18 Years -	Qilu Puget Sound Biotherapeutics (dba Sound Biologics)

Spots Global Cancer Trial Database for psb205

Every month we try and update this database with for psb205 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for psb205

Every month we try and update this database with for psb205 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for psb205 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.