A Phase 1 Study of MEDI0562 in Adult Subjects With Selected Advanced Solid Tumors

This is a first-time-in-human (FTiH) Phase 1, multicenter, open-label, dose-escalation, and dose-expansion study of MEDI0562 to evaluate the safety, tolerability, pharmacokinetics, immunogenicity, pharmacodynamics and preliminary anti-tumor activity in adult subjects with selected advanced solid tumors.

Inclusion criteria

• Subjects must have confirmed advanced solid tumor and have progressed, are refractory, or are intolerant to standard therapy appropriate for tumor type. Subjects should not have received more than 3 prior lines of therapy for recurrent or metastatic disease including both standards of care and investigational therapies.
• Subjects must have at least 1 measurable lesion.
• Consent to provide archived tumor specimens
• Willingness to undergo pre-treatment and on-treatment biopsy.
• Adequate organ function.
• Use of highly effective contraception (females) or male condom plus spermicide (males).

Exclusion criteria

• Prior treatment with TNFRSF agonists.
• Subjects who have received certain prior immunotherapy or had toxicities relating to prior immunotherapy may not be permitted to enroll.

o Must not have required the use of additional immunosuppression other than corticosteroids for the management of an adverse event.

• History of severe allergic reactions to any unknown allergens or any components of the study drug formulations.
• Receipt of any conventional or investigational anticancer therapy within 28 days prior to the first dose of MEDI0562.
• Any concurrent chemotherapy, immunotherapy, or biologic or hormonal therapy for cancer treatment.
• Unresolved toxicities from prior anticancer therapy.
• Any condition that, in the opinion of the investigator or sponsor, would interfere with evaluation of the investigational product.