A Study of PSB205 in Subjects With Advanced Solid Tumors
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03986606|
Recruitment Status : Recruiting
First Posted : June 14, 2019
Last Update Posted : November 25, 2020
|Condition or disease||Intervention/treatment||Phase|
|Neoplasm Malignant||Biological: PSB205||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||64 participants|
|Intervention Model:||Sequential Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Actual Study Start Date :||July 5, 2019|
|Estimated Primary Completion Date :||February 28, 2021|
|Estimated Study Completion Date :||July 28, 2021|
Experimental: Open-label Dose Escalation and Expansion Study of PSB205
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.
- Safety and tolerability [ Time Frame: 28 days ]Safety and tolerability, as defined by the rate of treatment-related adverse events as assessed by NCI CTCAE v5.0.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03986606
|Contact: Cynthia Erdman||1-913-410-2815||ErdmanCynthia@prahs.com|
|Contact: Jelle Kijilstra, M.D, MPH||1-425-398-2323||Jelle@soundbiologics.com|
|United States, Texas|
|San Antonio, Texas, United States, 78229|
|Contact: Anthony Tolcher, MD|