A Study of PSB205 in Subjects With Advanced Solid Tumors
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|ClinicalTrials.gov Identifier: NCT03986606|
Recruitment Status : Not yet recruiting
First Posted : June 14, 2019
Last Update Posted : June 14, 2019
|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|
|Estimated Study Start Date :||June 2019|
|Estimated Primary Completion Date :||February 2021|
|Estimated Study Completion Date :||July 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: 42 days ]Safety and tolerability, as defined by the rate of treatment-related adverse events as assessed by NCI CTCAE v5.0.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03986606
|Contact: Tiffinnie Paulson||1-913-574-6075||PaulsonTiffinnie@prahs.com|
|Contact: William C Fanslow, Ph.D||1-425-398-2323 ext firstname.lastname@example.org|