BGB-A317: This phase I trial is evaluating a new drug known as BGB-A317 in patients with advanced cancerA Phase 1, Open Label, Multiple Dose, Dose Escalation and Expansion Study to Investigate the Safety, Pharmacokinetics and Antitumor Activities of the Anti-PD-1 Monoclonal Antibody BGB-A317 in Subjects With Advanced Tumors

Inclusion

1. Participants must have had a histologically or cytologically confirmed advanced or metastatic tumor for which no effective standard therapy was available.

   1. For Phase 1A: no specific restriction
   2. For Phase 1B: histology specified below:

   i. non-small cell lung cancer (participants with documented epidermal growth factor receptor mutation or anaplastic lymphoma kinase rearrangement should have been excluded) ii. ovarian cancer iii. gastric cancer iv. hepatocellular carcinoma (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. head and neck squamous cell carcinoma vi. esophageal carcinoma vii. triple negative breast cancer viii. cholangiocarcinoma ix. renal cell cancer, bladder cancer, melanoma, Merkel-cell carcinoma, sarcoma, gastrointestinal stromal tumor, or cutaneous squamous cell carcinoma. Or any other solid tumors with known microsatellite instability-high or mismatch repair deficient status, such as colorectal cancer or pancreatic cancer

2. Participants with previously treated brain metastasis (es) that were asymptomatic or radiographically/clinically stable and not requiring steroids medications for 4 weeks prior to enrollment were permitted.
3. Participants must have had archival tumor tissues or agreed to a tumor biopsy for analysis of predictive biomarkers such as programmed death-ligand 1 (PD-L1). (Fresh tumor biopsies were strongly recommended at baseline for biomarker analysis in participants with readily accessible tumor lesions and who consented to the biopsies).
4. Participants must have had measurable disease as defined per Response Evaluation Criteria in Solid Tumor Version 1.1.
5. Eastern Cooperative Oncology Group performance status of ≤ 1.

6. Participants must have had adequate organ function as indicated by the following laboratory values:

   • Absolute neutrophil count ≥ 1,500 /microliter
   • Platelets ≥ 100,000 / milliliter (mL)
   • Hemoglobin ≥ 9 grams/deciliter or ≥ 5.6 millimoles/liter
   • Serum creatinine ≤ 1.5 X upper limit of normal (ULN)
   • Serum total bilirubin ≤ 1.5 X ULN
   • Aspartate aminotransferase (serum glutamic oxaloacetic transaminase) and alanine aminotransferase (serum glutamic pyruvic transaminase) ≤ 2.5 X ULN or ≤ 5 X ULN for participants with liver metastases
   • International normalized ratio or prothrombin time ≤ 1.5 X ULN
   • Activated partial thromboplastin time ≤ 1.5 X ULN