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

Protocol: 
AAAQ7663
Phase: 
I

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 primary objective is to assess safety and tolerability, describe the dose-limiting toxicities (DLTs), and determine the maximum tolerated dose (MTD) or the maximum administered dose (MAD; in the absence of exceeding the MTD) for the combination of MEDI0562 and MEDI4736 or tremelimumab in subjects with advanced solid tumors.

Are you Eligible? (Inclusion Criteria)

1. Age >= 18 years at the time of study entry.
2. 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
disease
(including both standard of care and investigational therapies).
3. Subjects must have at least 1 lesion that is measurable using irRECIST
guidelines.
4. ECOG Performance Score of 0 or 1.

Trial Location

Herbert Irving Comprehensive Cancer Center
161 Fort Washington Ave.
Herbert Irving Pavilion
New York, NY 10032
United States