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MGA012: A Phase 1 Study of the Safety, Tolerability, and Pharmacokinetics of MGA012 in Patients with Advanced Solid Tumors (Endometrial and Sarcoma Cohorts)

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MGA012: A Phase 1 Study of the Safety, Tolerability, and Pharmacokinetics of MGA012 in Patients with Advanced Solid Tumors (Endometrial and Sarcoma Cohorts)

The primary objective of this study is to characterize the safety, tolerability, DLTs, and MTD, or MAD (if no MTD is defined), of MGA012 when administered IV every two or four weeks to patients who have relapsed/refractory unresectable locally advanced or metastatic solid
tumors.

The secondary objectives of this study are:
h To characterize the PK and immunogenicity of MGA012.
h To investigate the preliminary anti-tumor activity of MGA012 using both
conventional Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 and immune-related response criteria (irRECIST)

Protocol Number: 051611
Phase: Phase I
Applicable Disease Sites: Any Site
Drugs Involved: INCMGA00012
MGA012
Principal Investigator: Janice Mehnert
Scope: National
Therapies Involved: Chemotherapy single agent systemic
Participating Institutions: Rutgers Cancer Institute of New Jersey
Inclusion & Exclusion Criteria

Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site www.clinicaltrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria. For additional information on this trial or other available clinical trials please contact the research nurse.

For further information about clinical trials, please contact us at 732-235-8675.

 

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