MEDI5752 in Japanese Patients With Advanced Solid Tumors.

<Objectives>

Primary Objective:

To evaluate the safety and tolerability of MEDI5752 in Japanese subjects with advanced solid tumors.

Secondary Objective:

To assess the anti-tumor activity and efficacy of MEDI5752. To describe the pharmacokinetics of MEDI5752.

Exploratory Objective:

To conduct exploratory research into factors that may be predictive of response or may influence the progression of cancer and/or response (efficacy) to MEDI5752.

Eligible patients will be administered as a single dose at each Cycle Day1. Each cycle from Cycle 1 has a duration of 21 days.

A minimum of 3 and a maximum of 9 evaluable patients will be enrolled in each cohort.

Inclusion criteria

• Age ≥ 18 years at the time of screening
• World Health Organization/Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at enrollment
• Life expectancy ≥ 12 weeks
• Histologically or cytologically-confirmed advanced solid tumors
• Subjects 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 applicable
• Females of childbearing potential who are sexually active with a nonsterilized male partner must use at least one highly effective method of contraception
• Nonsterilized 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 lesion
• Adequate organ and marrow function
• Signed and dated written informed consent
• Subjects must provide tumor material as applicable

Exclusion criteria

• Involvement 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 study
• For 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 disorders
• History of organ transplant
• Known allergy or reaction to any component of the planned study treatment.
• Untreated CNS metastatic disease, leptomeningeal disease, or cord compression
• Unresolved 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 criteria
• Major surgical procedure (as defined by the investigator) within 28 days prior to the first dose of Investigational Product or still recovering from prior surgery
• Female 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 control
• Uncontrolled 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 results
• Judgment 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.