A Study of MEDI5395 in Combination With Durvalumab in Subjects With Select Advanced Solid Tumors

This is an Phase 1, first-in-human, open-label, dose-escalation, and dose-expansion study to
assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics and preliminary
efficacy of MEDI5395 in combination with durvalumab in subjects with selected advanced solid
tumors.

Inclusion Criteria

- The subject must consent to take precautionary measures to prevent Newcastle Disease
Virus (NDV) transmission to humans and birds

- Subjects must have histologic documentation of advanced solid tumor and received and
have progressed, are refractory, or are intolerant to standard therapy for the
specific tumor type. All subjects are required to have had at least one prior line of
treatment in the recurrent or metastatic setting

- Subjects must have at least 1 measurable lesion

- All subjects must consent to provide tumor tissue for correlative studies

- ECOG performance status of 0 to 1

- Adequate organ function

- Use of highly effective contraception (females) or male condom plus spermicide (males)

Exclusion Criteria

- Rapidly progressing disease defined as a subject that cannot tolerate a break of at
least 8 weeks from systemic anticancer therapy.

- Primary central nervous system (CNS) disease is excluded

- Subjects who have received prior immunotherapy will require varying washout times
prior to the first dose of MEDI5395

- Unresolved toxicities from prior anticancer therapy

- History of severe allergic reactions to any of the study drug components

- Infectious disease exclusions including tuberculosis, Human immunodeficiency virus
(HIV), hepatitis A, B or C, active bacterial, fungal or viral infections plus receipt
of live attenuated vaccine prior to first dose of MEDI5395. (NOTE: Subjects with
hepatitis B/C with undetectable virus load and are on medications may be permitted).

- Any conditions requiring use of any systemic immunosuppressant including systemic
corticosteroids, methotrexate, azathioprine, tumor necrosis factor (TNF) inhibitor,
and/or interleukin 6 (IL-6) blockers

- Active autoimmune disease or chronic inflammatory condition (Exceptions include
vitiligo, alopecia, hypothyroidism on stable treatment, diverticulosis, controlled
celiac disease and chronic skin conditions not requiring systemic therapy)

- Active acquired immune-deficiency states

- Subjects who are regularly exposed to poultry or birds

- Current active hepatitis or biliary disease (except for Gilbert's syndrome,
asymptomatic gallstones, or stable chronic liver disease)

- Clinically significant pulmonary disease and cardiac disease

- Any condition that, in the opinion of the investigator, would interfere with
evaluation of the investigational product or interpretation of subject safety or study
results.