Condition or disease | Intervention/treatment | Phase |
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Neoplasm Malignant | Biological: PSB205 | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 64 participants |
Allocation: | N/A |
Intervention Model: | Sequential Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 |
Arm | Intervention/treatment |
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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. |
Biological: PSB205
PSB205 is a bi-functional product that has been engineered to contain two unique monoclonal antibodies.
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Suitable venous access for the study-required blood sampling, including PK and Pharmacodynamic sampling.
To be enrolled in Part 1 (Dose escalation), subjects must have:
To be enrolled in Part 2 (Dose expansion), subjects must have:
Exclusion Criteria:
Subjects with any of the following cardiovascular conditions are excluded:
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 | |
Next Oncology | Recruiting |
San Antonio, Texas, United States, 78229 | |
Contact: Anthony Tolcher, MD | |
Contact: MD |
Tracking Information | |||||||||
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First Submitted Date ICMJE | June 4, 2019 | ||||||||
First Posted Date ICMJE | June 14, 2019 | ||||||||
Last Update Posted Date | November 25, 2020 | ||||||||
Actual Study Start Date ICMJE | July 5, 2019 | ||||||||
Estimated Primary Completion Date | February 28, 2021 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
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.
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Original Primary Outcome Measures ICMJE |
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.
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Change History | |||||||||
Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | A Study of PSB205 in Subjects With Advanced Solid Tumors | ||||||||
Official Title ICMJE | 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 | ||||||||
Brief 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. | ||||||||
Detailed Description | Not Provided | ||||||||
Study Type ICMJE | Interventional | ||||||||
Study Phase ICMJE | Phase 1 | ||||||||
Study Design ICMJE | Allocation: N/A Intervention Model: Sequential Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Neoplasm Malignant | ||||||||
Intervention ICMJE | Biological: PSB205
PSB205 is a bi-functional product that has been engineered to contain two unique monoclonal antibodies.
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Study Arms ICMJE | 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. Intervention: Biological: PSB205
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Publications * | Not Provided | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status ICMJE | Recruiting | ||||||||
Estimated Enrollment ICMJE |
64 | ||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||
Estimated Study Completion Date ICMJE | July 28, 2021 | ||||||||
Estimated Primary Completion Date | February 28, 2021 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | United States | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT03986606 | ||||||||
Other Study ID Numbers ICMJE | PSB205-001 | ||||||||
Has Data Monitoring Committee | No | ||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Qilu Puget Sound Biotherapeutics (dba Sound Biologics) | ||||||||
Study Sponsor ICMJE | Qilu Puget Sound Biotherapeutics (dba Sound Biologics) | ||||||||
Collaborators ICMJE | Pharmaceutical Research Associates | ||||||||
Investigators ICMJE | Not Provided | ||||||||
PRS Account | Qilu Puget Sound Biotherapeutics (dba Sound Biologics) | ||||||||
Verification Date | November 2020 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |