Safety Study of MGD009 in B7-H3-expressing Tumors
|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|
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- 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 MGD006 using both conventional RECIST 1.1 and immune-related RECIST criteria.
|Study Start Date:||September 2015|
|Estimated Study Completion Date:||December 2020|
|Estimated Primary Completion Date:||December 2018 (Final data collection date for primary outcome measure)|
Humanized B7-H3 x CD3 Dual-Affinity Re-Targeting (DART®) Protein
B7-H3 x CD3 DART protein
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.
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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT02628535
|Contact: Bing Niefirstname.lastname@example.org|
|United States, North Carolina|
|Carolina BioOncology Institute||Recruiting|
|Huntersville, North Carolina, United States, 28078|
|Contact: Jaelyn Linski 704-947-6599 ext 111 email@example.com|
|Principal Investigator: John D. Powderly, M.D.|
|United States, Pennsylvania|
|Penn Presbyterian Medical Center||Recruiting|
|Philadelphia, Pennsylvania, United States, 19104|
|Contact: Mona S Jacobs-Small, BS, RRT, CCRC 215-662-8632|
|Principal Investigator: Evan Alley, M.D.|
|United States, Texas|
|South Texas Accelerated Research Therapeutics, LLC||Recruiting|
|San Antonio, Texas, United States, 78229|
|Contact: Leslie Smetzer 210-593-5269 firstname.lastname@example.org|
|Principal Investigator: Anthony Tolcher, M.D.|
|Study Chair:||James Vasselli, M.D.||MacroGenics|