Safety Study of MGD009 in B7-H3-expressing Tumors
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ClinicalTrials.gov Identifier: NCT02628535 |
Recruitment Status :
Terminated
(Business decision (not for safety reasons))
First Posted : December 11, 2015
Last Update Posted : February 8, 2022
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Tracking Information | |||
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First Submitted Date ICMJE | November 20, 2015 | ||
First Posted Date ICMJE | December 11, 2015 | ||
Last Update Posted Date | February 8, 2022 | ||
Study Start Date ICMJE | September 2015 | ||
Actual Primary Completion Date | November 25, 2019 (Final data collection date for primary outcome measure) | ||
Current Primary Outcome Measures ICMJE |
Number of participants with adverse events [ Time Frame: 28 days after last dose of study drug ] adverse events, serious adverse events
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Original Primary Outcome Measures ICMJE | Same as current | ||
Change History | |||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | ||
Original Other Pre-specified Outcome Measures | Not Provided | ||
Descriptive Information | |||
Brief Title ICMJE | Safety Study of MGD009 in B7-H3-expressing Tumors | ||
Official Title ICMJE | Phase 1, First-in-Human, Open Label, Dose Escalation Study of MGD009, A Humanized B7-H3 x CD3 Dual-Affinity Re-Targeting (DART) Protein in Patients With Unresectable or Metastatic B7-H3-Expressing Neoplasms | ||
Brief Summary | The purpose of this study is to evaluate the safety of MGD009 when given to patients with B7-H3-expressing tumors. The study will also evaluate what is the highest dose of MGD009 that can be given safely. Assessments will be done to see how the drug acts in the body (pharmacokinetics (PK), pharmacodynamics (PD) and to evaluate potential anti-tumor activity of MGD009. | ||
Detailed Description | This study is a Phase 1 open-label, dose escalation, cohort expansion, and efficacy follow-up study of MGD009 administered intravenously (IV) on an every-other-week schedule for up to one year (14 cycles). The dose escalation phase is designed to characterize the safety and tolerability of MGD009 and to define the maximum tolerated or maximum administered dose (MTD/MAD). This phase will enroll patients with mesothelioma, bladder cancer, melanoma, squamous cell carcinoma of the head and neck (SCCHN), non-small cell lung cancer (NSCLC), clear cell renal cell carcinoma (ccRCC), ovarian cancer, thyroid cancer, triple-negative breast cancer (TNBC), pancreatic cancer, colon cancer, soft tissue sarcoma, or prostate cancer. In the cohort expansion phase, 6 cohorts of 16 patients each will be enrolled to further evaluate the safety and potential efficacy of MGD009 administered at the MTD/MAD dose in patients with mesothelioma, bladder cancer, melanoma, SCCHN, NSCLC, or other specific tumors that express high levels of B7-H3. Pre- and on-study biopsies are required for melanoma patients in the cohort expansion phase. Two additional cohorts (up to15 patients each) will evaluate the use of prophylaxis therapies to mitigate toxicity. The survival follow-up phase consists of the 2-year period after the final dose of study drug. All tumor evaluations will be carried out by both Response Evaluation Criteria in Solid Tumors (RECIST) and immune-related response criteria (irRC). |
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Study Type ICMJE | Interventional | ||
Study Phase ICMJE | Phase 1 | ||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE | Biological: MGD009
B7-H3 x CD3 DART protein
Other Name: orlotamab
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Study Arms ICMJE | Experimental: MGD009
Orlotamab; Humanized B7-H3 x CD3 Dual-Affinity Re-Targeting (DART®) Protein
Intervention: Biological: MGD009
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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 | Terminated | ||
Actual Enrollment ICMJE |
67 | ||
Original Estimated Enrollment ICMJE |
114 | ||
Actual Study Completion Date ICMJE | November 25, 2019 | ||
Actual Primary Completion Date | November 25, 2019 (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 | Contact information is only displayed when the study is recruiting subjects | ||
Listed Location Countries ICMJE | Australia, Canada, United States | ||
Removed Location Countries | |||
Administrative Information | |||
NCT Number ICMJE | NCT02628535 | ||
Other Study ID Numbers ICMJE | CP-MGD009-01 | ||
Has Data Monitoring Committee | No | ||
U.S. FDA-regulated Product | Not Provided | ||
IPD Sharing Statement ICMJE |
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Current Responsible Party | MacroGenics | ||
Original Responsible Party | Same as current | ||
Current Study Sponsor ICMJE | MacroGenics | ||
Original Study Sponsor ICMJE | Same as current | ||
Collaborators ICMJE | Not Provided | ||
Investigators ICMJE | Not Provided | ||
PRS Account | MacroGenics | ||
Verification Date | February 2022 | ||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |