A Phase 1/2 Study to Evaluate MEDI4736

A dose-escalation and dose-expansion study of MEDI4736 (a monoclonal antibody that targets
programmed cell death-1 ligand 1 (PD-L1)) will evaluate the safety, tolerability, PK, IM, and
antitumor activity of MEDI4736 in adult patients with solid tumors. A dose exploration cohort
will look at the safety profile of Q4W dosing of MEDI4736.

Inclusion Criteria:

- Age 18 or older.

- In the dose-escalation phase: histologically- or cytologically- confirmed advanced
solid tumor that is refractory to standard therapy and for which no standard therapy
exists.

- In the dose-expansion phase: histologically- or cytologically- confirmed advanced
solid tumor where if an approved first-line therapy is available, subjects must have
failed, be intolerant to, be ineligible for, or have refused

- Eastern Cooperative Oncology Group (ECOG) status of 0 or 1.

- Adequate organ and marrow function.

- Subjects must have at least 1 measurable lesion.

- Available archived tumor tissue sample.

- Willingness to provide consent for biopsy sample (dose-expansion only)

Exclusion Criteria:

- Any prior Grade ≥ 3 irAE while receiving immunotherapy

- Prior exposure to any anti-PD-1 or anti-PD-L1 antibody

- Any concurrent chemotherapy, immunotherapy, biologic or hormonal therapy for cancer
treatment.

- Prior treatment with immunotherapy agents including, but not limited to, tumor
necrosis factor receptor superfamily agonists or checkpoint inhibitors or natural
killer (NK) cell inhibitors.

- Active or prior documented autoimmune disease within the past 2 years

- History of primary immunodeficiency

- History of organ transplant that requires use of immunosuppressives

- Symptomatic or untreated central nervous system (CNS) metastases requiring concurrent
treatment

- Other invasive malignancy within 2 years

- Women who are pregnant or lactating

- Uncontrolled intercurrent illness

- Known history of tuberculosis

- Known to be human immunodeficiency virus (HIV) positive

- Known to be Hepatitis B or C positive (except HCC patients)