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

A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Clinical Activity of MEDI0562 in Adult Subjects With Selected Advanced Solid Tumors

To evaluate the safety and tolerability 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.