MEDI9447 Alone and in Combination With MEDI4736 in Adult Subjects With Select Advanced Solid Tumors

Inclusion Criteria:

- Adult subjects; age ≥ 18

- Written and signed informed consent must be obtained

- Have histologic or cytologic documentation of solid tumor including EGFR mutated
(EGFRm) NSCLC

- Subjects must have at least 1 lesion that is measureable using RECIST guidelines

- Subjects must consent to provide archived tumor specimens or tumor biopsies for
correlative biomarker studies.

- Eastern Cooperative Oncology Group performance score of 0 or 1

- Adequate organ function

Exclusion Criteria:

- Prior treatment with tumor necrosis factor receptor superfamily agonists including
OX40, CD27, CD137 (4-1BB), CD357 (GITR). One cohort also excludes anti CTLA-4, anti
PDL-1 and anti PDL-1.

- Subjects who have received prior therapy with regimens containing CTLA-4, PD-L1, or
PD-1 antagonists may be permitted to enroll under certain conditions

- Cardiac or peripheral vascular disease meeting any of the following criteria:

- Past history of myocardial infarction in the prior 12 months

- Past history of stroke or transient ischemic attack requiring medical therapy

- Congestive heart failure ≥ Class 3 based on New York Heart Association Functional
Classification

- Grade 3 or greater edema (eg, peripheral, pulmonary)

- History of Grade 3 or greater thromboembolic events in the prior 12 months

- Subjects with active tuberculosis are ineligible. In settings where there is clinical
or radiographic evidence of tuberculosis, active disease must be ruled out

- Active or prior documented autoimmune or inflammatory disorders

- Untreated central nervous system (CNS) metastatic disease

- Known positive for human immunodeficiency virus (HIV), chronic or active hepatitis B
or active hepatitis A or C

- Other invasive malignancy within 2 years except for noninvasive malignancies such as
cervical carcinoma in situ, in situ prostate cancer, non-melanomatous carcinoma of the
skin, ductal carcinoma in situ of the breast that has been surgically cured

- Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, active peptic ulcer disease or gastritis, uncontrolled hypertension,
uncontrolled diabetes, or psychiatric illness/social situations that would limit
compliance with study requirement