A Phase 1 Study to Evaluate MEDI6383 Alone and in Combination With MEDI4736 in Adult Subjects With Select Advanced Solid Tumors
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02221960|
Recruitment Status : Completed
First Posted : August 21, 2014
Last Update Posted : March 13, 2019
|Condition or disease||Intervention/treatment||Phase|
|Recurrent or Metastatic Solid Tumors||Biological: MEDI6383 Biological: MEDI6383 and MEDI4736||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||39 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1 Multicenter, Open-label, Dose-escalation and Dose-expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Antitumor Activity of MEDI6383 Alone and in Combination With MEDI4736 in Adult Subjects With Select Advanced Solid Tumors|
|Actual Study Start Date :||September 15, 2014|
|Actual Primary Completion Date :||July 3, 2017|
|Actual Study Completion Date :||July 3, 2017|
Experimental: Monotherapy Arm
Subjects will receive MEDI6383 until disease progression or adverse event.
Experimental: Combination Arm
MEDI6383 and MEDI4736
Biological: MEDI6383 and MEDI4736
Subjects will recieve MEDI6383 and MEDI4736 until disease progression or adverse event.
- Safety [ Time Frame: From time of informed consent through 12 weeks after last dose of investigational product ]Primary endpoint will be the number (%) of subjects with adverse events and serious adverse events.
- Preliminary Antitumor Activity [ Time Frame: Duration of Study ]The endpoints for assessment of antitumor activity include objective response (OR), disease control (DC), duration of response (DoR), progression-free survival (PFS), and 3-year overall survival (OS)
- Pharmacokinetics of MEDI6383 or MEDI6383/MEDI4736 [ Time Frame: From time of informed consent through 12 weeks after last dose of investigational product ]When MEDI6383 is administered alone, the endpoints for assessment of PK of MEDI6383 include individual subject MEDI6383 concentrations in serum at different time points after MEDI6383 administration. When MEDI6383 is administered together with MEDI4736, the endpoints for assessment of PK of MEDI6383 and MEDI4736 include individual subject MEDI6383 and MEDI4736 concentrations in serum at different time points after MEDI6383 and MEDI4736 administration. PK Parameters that may be modeled may include Cmax, Area Under the concentration-time curve, Clearance, and terminal half-live.
- Biomarker Activity [ Time Frame: From time of informed consent through 12 weeks after last dose of investigational product ]The endpoints for assessment of pharmacodynamic activity include immunohistochemistry of tumor biopsies and assessment of tumor-infiltrating lymphocyte phenotypic markers
- Immunogenicity [ Time Frame: From time of informed consent through 12 weeks after last dose of investigational product ]The endpoint for for the assessment of immunogenicity will include the number and percentage of subjects that develop anti-drug antibodies.
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): NCT02221960
|United States, California|
|La Jolla, California, United States, 92093|
|United States, Connecticut|
|New Haven, Connecticut, United States, 06520|
|United States, District of Columbia|
|Washington, District of Columbia, United States, 20007|
|United States, Illinois|
|Chicago, Illinois, United States, 60611|
|United States, New York|
|New York, New York, United States, 10065|
|United States, Oregon|
|Portland, Oregon, United States, 97213|
|United States, Tennessee|
|Nashville, Tennessee, United States, 37203|
|Parkville, Australia, 3052|
|Study Director:||Medimmune Medimmune||MedImmune LLC|