Study of the Safety, Pharmacokinetics and Antitumor Activities of BGB-A317 in Subjects With Advanced Tumors

Inclusion Criteria:

1. Subjects must have a histologically or cytologically confirmed advanced or metastatic
tumor for which no effective standard therapy is available.

1. For Phase 1A: no specific restriction

2. For Phase 1B: histology specified below

i. NSCLC (subjects with documented EGFR mutation or ALK rearrangement should be
excluded) ii. ovarian cancer iii. gastric cancer iv. HCC (Barcelona-Clinic Liver
Cancer stage C, stage B not amenable to locoregional therapy or refractory to
locoregional therapy, and not amenable to a curative treatment approach, and
Child-Pugh A) v. HNSCC vi. esophageal carcinoma vii. TNBC viii. cholangiocarcinoma ix.
RCC, bladder cancer, melanoma, Merkel-cell carcinoma, sarcoma, GIST, or cuSCC. Or any
other solid tumors with known MSI-H or dMMR status, such as CRC or pancreatic cancer

2. Subjects with previously treated brain metastasis (es) that is asymptomatic or
radiographically/clinically stable and not requiring steroids medications for 4 weeks
prior to enrollment are permitted.

3. Subjects must have archival tumor tissues or agree to a tumor biopsy for analysis of
predictive biomarkers such as PD-L1. (Fresh tumor biopsies are strongly recommended at
baseline for biomarker analysis in subjects with readily accessible tumor lesions and
who consent to the biopsies.)

4. Subjects must have measurable disease as defined per RECIST Version 1.1.

5. Male or female and ≥18 years of age on day of signing informed consent.

6. Eastern Cooperative Oncology Group (ECOG) performance status of ≤1.

7. Subjects must have adequate organ function as indicated by the following laboratory
values.

- Absolute neutrophil count (ANC) ≥1,500 /mL

- Platelets ≥100,000 / mL

- Hemoglobin ≥9 g/dL or ≥5.6 mmol/L- without qualifications

- Serum creatinine ≤1.5 X upper limit of normal (ULN)

- Serum total bilirubin ≤ 1.5 X ULN

- AST (SGOT) and ALT (SGPT) ≤ 2.5 X ULN OR ≤ 5 X ULN for patients with liver
metastases

- International Normalized Ratio (INR) or Prothrombin Time (PT) ≤1.5 X ULN

- Activated Partial Thromboplastin Time (aPTT) ≤1.5 X ULN

Exclusion Criteria:

1. History of severe hypersensitivity reactions to other mAbs.

2. Prior malignancy active within the previous 2 years except for tumor for which a
patient is enrolled in the study, and locally curable cancers that have been
apparently cured, such as basal or squamous cell skin cancer, superficial bladder
cancer or carcinoma in situ of the cervix or breast.

3. Prior therapies targeting PD-1 or PD-L1.

4. Subjects who fail to meet enrollment criteria for other PD-1 or PD-L1 trials solely
due to low or negative predictive biomarkers.

5. Subjects with active autoimmune diseases or history of autoimmune diseases should be
excluded.

6. Subjects should be excluded if they have a condition requiring systemic treatment with
either corticosteroids (> 10 mg daily prednisone equivalents) or other
immunosuppressive medications within 14 days of study drug administration.

7. Has history of interstitial lung disease or non-infectious pneumonitis except for
those induced by radiation therapies..

8. Known history of Human Immunodeficiency Virus;

9. Active infection requiring therapy, positive tests for Hepatitis B surface antigen or
Hepatitis C ribonucleic acid (RNA) except in patients with HCC, who meet the following
criteria:

- HBV viral load (VL) <200 IU/mL (approximately 1000 cps/mL)

- Subjects with active HBV infection need to be on anti-HBV suppression ≥3 months,
throughout treatment and for 6 months after

- Subjects HCV-positive after successful treatment (defined as sustained virologic
response [SVR] 12 or SVR 24) are allowed as long as 4 weeks have passed between
completion of HCV therapy and start of study drug

10. Use of any vaccines against infectious diseases (e.g., influenza, varicella, etc.)
within 4 weeks (28 days) of initiation of study therapy and 60 days after the last
administration of the study medication.