A Study of XmAb®20717 in Subjects With Selected Advanced Solid Tumors (DUET-2)
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ClinicalTrials.gov Identifier: NCT03517488 |
Recruitment Status :
Recruiting
First Posted : May 7, 2018
Last Update Posted : April 11, 2022
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Sponsor:
Xencor, Inc.
Collaborator:
ICON plc
Information provided by (Responsible Party):
Xencor, Inc.
Tracking Information | |||||||||
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First Submitted Date ICMJE | April 23, 2018 | ||||||||
First Posted Date ICMJE | May 7, 2018 | ||||||||
Last Update Posted Date | April 11, 2022 | ||||||||
Actual Study Start Date ICMJE | July 10, 2018 | ||||||||
Estimated Primary Completion Date | November 30, 2022 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
Determine the safety and tolerability profile of XmAb20717 [ Time Frame: 56 Days ] Treatment-related adverse events as assessed by CTCAE v4.03
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Original Primary Outcome Measures ICMJE | Same as current | ||||||||
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 XmAb®20717 in Subjects With Selected Advanced Solid Tumors | ||||||||
Official Title ICMJE | A Phase 1 Multiple Dose Study to Evaluate the Safety and Tolerability of XmAb®20717 in Subjects With Selected Advanced Solid Tumors | ||||||||
Brief Summary | This is a Phase 1, multiple dose, ascending dose escalation study to define a MTD/RD and regimen of XmAb20717, to describe safety and tolerability, to assess PK and immunogenicity, and to preliminarily assess anti-tumor activity of XmAb20717 in subjects with selected advanced solid tumors. | ||||||||
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 |
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Intervention ICMJE | Biological: XmAb20717
Monoclonal bispecific antibody
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Study Arms ICMJE | Experimental: XmAb20717
XmAb20717 administered by intravenous dosing on Days 1 and 15 of each 28-day cycle for a total of two cycles
Intervention: Biological: XmAb20717
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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 |
154 | ||||||||
Original Estimated Enrollment ICMJE |
87 | ||||||||
Estimated Study Completion Date ICMJE | February 28, 2023 | ||||||||
Estimated Primary Completion Date | November 30, 2022 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
PART A (Dose Escalation Cohorts)
PART B (Dose Expansion Cohorts):
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 | NCT03517488 | ||||||||
Other Study ID Numbers ICMJE | XmAb20717-01 DUET-2 ( Other Identifier: Xencor, Inc. ) |
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Has Data Monitoring Committee | Yes | ||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Xencor, Inc. | ||||||||
Study Sponsor ICMJE | Xencor, Inc. | ||||||||
Collaborators ICMJE | ICON plc | ||||||||
Investigators ICMJE |
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PRS Account | Xencor, Inc. | ||||||||
Verification Date | April 2022 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |