A Study in Adult Subjects With Select Advanced Solid Tumors

A Phase 1 Study of MEDI1873 (GITR Agonist) in Adult Subjects With Select Advanced Solid Tumors

To evaluate the safety and tolerability of MEDI1873 in adult subjects with selected advanced solid tumors.

This is a first-time-in-human, Phase 1, multicenter, open-label, single-arm dose-escalation study of MEDI1873 to evaluate the safety, tolerability, pharmacokinetics, immunogenicity, pharmacodynamics and anti-tumor activity in adult subjects with advanced solid tumor malignancies

Inclusion Criteria:

• All subjects must consent to provide archived tumor specimen
• Subjects must have histologically or cytologically confirmed advanced solid tumor for recurrent or metastatic disease.
• At the time of Day 1 of the study, subjects with central nervous system (CNS) metastases must have been treated and must be asymptomatic
• Willingness to provide pretreatment and on-treatment biopsies.
• Adequate organ function
• Females of childbearing potential and nonsterilized males who are sexually active must use effective methods of contraception

Exclusion Criteria:

• Known allergic reaction to any component of MEDI1873
• Concurrent enrollment in another clinical study, unless it is an observational clinical study or the follow-up period of an interventional study
• Receipt of any anticancer therapy within 4 weeks prior to the first dose of MEDI1873; in the case of mAbs, 6 weeks prior to the first dose of MEDI1873
• Any concurrent chemotherapy, immunotherapy, biologic, or hormonal therapy for cancer treatment.
• Receipt of live, attenuated vaccine within 28 days prior to the first dose of investigational product
• 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.