A Phase 1 Multicenter, Open-label, Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, Immunogenicity, and Antitumor Activity of MEDI0562 in Combination with Immune Therapeutic Agents in Adult Subjects with Advanced Solid Tumors
The purpose of this study is to evaluate MEDI0562 in combination with immune therapeutic agents in adult subjects with select advanced solid tumors.
• Subjects must have received and have progressed, are refractory, or are intolerant to standard therapy appropriate for the specific tumor type. Subjects should not have received more than 3 prior lines of systemic therapy for recurrent or metastatic.
• Subjects in the dose-escalation phase, must have histologic documentation of advanced solid tumors, excluding primary CNS tumors and hematologic malignancies.
• Subjects in the dose-expansion phase, must have histologic diagnosis of advanced -relapsed or -refractory solid tumors as specified in the protocol.
• Subjects who have received prior therapy with regimens containing CTLA 4, PD L1, or PD 1 antagonists are permitted to enroll if additional protocol criteria are met.
• Subjects must have at least 1 lesion that is measurable using RECIST guidelines.
• Subjects must consent to provide archived tumor specimens for correlative biomarker studies. In the setting where archival material is unavailable or unsuitable for use, subjects must consent and undergo fresh tumor biopsy.
• All subjects are encouraged to consent to and provide both pretreatment and on treatment tumor biopsies.
• ECOG Performance score of 0 or 1
• In the opinion of the investigator likely to complete ≥ 8 weeks of treatment.
• Adequate hematologic, renal and hepatic function as determined by blood laboratory values.
• At the time of Day 1 of the study, subjects with CNS metastases must have been treated and must be asymptomatic and meet the following:
a. No concurrent treatment, inclusive of, but not limited to surgery, radiation, and/or corticosteroids
b. At least 42 days without progression of CNS metastases as evidenced by magnetic resonance imaging (MRI) or computed tomography (CT) after last day of treatment
c. At least 14 days since last dose of corticosteroids Note: Subjects with leptomeningeal disease or cord compression are excluded from the study.
Multiple Tumor Types
Brendan Curti, M.D.
- Oncology and Hematology Care Eastside