Safety Study of MGD009 in B7-H3-expressing Tumors
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|ClinicalTrials.gov Identifier: NCT02628535|
Recruitment Status : Active, not recruiting
First Posted : December 11, 2015
Last Update Posted : August 13, 2019
|Condition or disease||Intervention/treatment||Phase|
|Mesothelioma Bladder Cancer Melanoma Squamous Cell Carcinoma of the Head and Neck Non Small Cell Lung Cancer Clear Cell Renal Cell Carcinoma Ovarian Cancer Thyroid Cancer Breast Cancer Pancreatic Cancer Prostate Cancer Colon Cancer Soft Tissue Sarcoma||Biological: MGD009||Phase 1|
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).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Study Start Date :||September 2015|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||March 2020|
Orlotamab; Humanized B7-H3 x CD3 Dual-Affinity Re-Targeting (DART®) Protein
B7-H3 x CD3 DART protein
Other Name: orlotamab
- Number of participants with adverse events [ Time Frame: 28 days after last dose of study drug ]adverse events, serious adverse events
- Peak plasma concentration [ Time Frame: 8 days ]PK of MGD009
- Number of participants that develop anti-drug antibodies [ Time Frame: first dose through 28 days after last dose of study drug ]Proportion of patients who develop anti-MGD0009 antibodies, immunogenicity
- Change in tumor volume [ Time Frame: Weeks 6, 15, 24, 33, 42, 51, 60, 69, 78, 87, 96, 105 ]Anti-tumor activity of MGD009 using both conventional RECIST 1.1 and immune-related RECIST criteria.
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): NCT02628535
|Study Chair:||Stacie Goldberg, M.D.||MacroGenics|