This is a phase 1 dose escalation study to characterize the feasibility, safety and tolerability of MCY-M11 when administered as an intraperitoneal (IP) infusion for 3 weekly doses for women with platinum resistant high grade serous adenocarcinoma of the ovary, primary peritoneum, or fallopian tube, and subjects with peritoneal mesothelioma with recurrence after prior chemotherapy. The study will also assess multiple cycles of treatment and adding preconditioning with cyclophosphamide.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
14
Intraperitoneal administration
Intravenous administration for preconditioning
National Cancer Institute, National Institutes of Health
Rockville, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Washington University at St. Louis
St Louis, Missouri, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
Incidence and severity of adverse events as assessed by CTCAE v.5.0
number and severity of adverse events according to NCI CTCAE v.5.0
Time frame: 6 weeks
Response Evaluation Criteria in Solid Tumors (RECIST)
tumor response scored by RECIST criteria
Time frame: from first MCY-M11 dosing to first documented progression, assessed up to 24 months
Immune-related Response Evaluation Criteria in Solid Tumors (irRECIST)
tumor response scored by irRECIST criteria
Time frame: from first MCY-M11 dosing to first documented progression, assessed up tp 24 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.