MEDI5752 in Japanese Patients With Advanced Solid Tumors.

This is a Phase 1, open-label study evaluate the safety, tolerability, pharmacokinetics, immunogenicity and anti-tumor activity of MEDI5752 in Japanese patients with advanced solid solid tumors.

Inclusion CriteriaAge ≥ 18 years at the time of screeningWorld Health Organization/Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at enrollmentLife expectancy ≥ 12 weeksHistologically or cytologically-confirmed advanced solid tumorsSubjects who have received prior anti-PD-1, anti-PD-L1, or anti-CTLA-4 therapy or any concurrent chemotherapy, radiotherapy, investigational, biologic, or hormonal therapy for cancer treatment may be eligible to enter the study following a washout period as applicableFemales of childbearing potential who are sexually active with a nonsterilized male partner must use at least one highly effective method of contraceptionNonsterilized males who are sexually active with a female partner of childbearing potential must use a male condom from Day 1 and for 90 days after the final dose of investigational product.Subjects must have at least one measurable lesionAdequate organ and marrow functionSigned and dated written informed consentSubjects must provide tumor material as applicableExclusion CriteriaInvolvement in the planning and/or conduct of the study (applies to both sponsor staff and/or staff at the study site)Concurrent enrollment in another clinical study, unless it is an observational clinical study or the follow-up period of an interventional studyFor subjects who have received prior anti-PD-1, anti-PD-L1, or anti-CTLA-4:Subjects must not have received anti-PD-1, anti-PD-L1, anti-CTLA-4 or any other immunotherapy or immune-oncology (IO) agent within 21 days of commencing treatment with investigational product.Subject must not have experienced a toxicity that led to permanent discontinuation of prior immunotherapy.All AEs while receiving prior immunotherapy must have completely resolved or resolved to Grade 1 prior to screening for this study.Current or prior use of immunosuppressive medication within 14 days before the first dose of investigational product is excluded.Receipt of live attenuated vaccine within 30 days prior to the first dose of investigational product.Active or prior documented autoimmune or inflammatory disordersHistory of organ transplantKnown allergy or reaction to any component of the planned study treatment.Untreated CNS metastatic disease, leptomeningeal disease, or cord compressionUnresolved toxicities from prior anticancer therapy, defined as having not resolved to NCI CTCAE v5.0 Grade 0 or 1, or to levels dictated in the inclusion/exclusion criteriaMajor surgical procedure (as defined by the investigator) within 28 days prior to the first dose of Investigational Product or still recovering from prior surgeryFemale subjects who are pregnant or breastfeeding, as well as male or female subjects of reproductive potential who are not willing to employ one highly effective method of birth controlUncontrolled intercurrent illness, that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the subject to give written informed consent.Any condition that, in the opinion of the investigator, would interfere with evaluation of the investigational product or interpretation of the subject's safety or study resultsJudgment by the investigator that the subject is unsuitable to participate in the study and the subject is unlikely to comply with study procedures, restrictions, and requirements.