IBI308 in Subjects With Advanced/Metastatic Solid Malignancies

Inclusion Criteria

• Subjects able to give voluntary informed consent, understand the study and are willing to follow and complete all the test procedures.
• Subjects (males and females) of childbearing potential should be willing to use reliable contraception methods that are deemed effective by the investigator from visit 1 through 90 days following the last dose of study drug. Postmenopausal women must have been amenorrhea for at least 12 months to be considered of non-childbearing potential.
• Male or female subjects ≥18 years
• At least one measurable lesion (per RECIST version 1.1)
• Eastern Cooperative Oncology Group (ECOG) Performance Status ≤1.
• Subjects with life expectancy of ≥ 3 month
• If subject received anti-tumor therapy:
• Generalized radiation therapy must have been completed 3 weeks prior to enrollment, or local radiotherapy or radiation therapy for bone metastases for 2 weeks prior to enrollment. Treatment with radiopharmaceuticals must have been completed 8 weeks prior to enrollment.
• Previous chemotherapy, biotherapy (tumor vaccines, cytokines, or growth factors that control cancer), tyrosine kinase inhibitors, or approved targeting and other treatments should have completed at least 3 weeks prior to the first administered dose in this study;
• Subjects must have adequate organ function (liver, kidney function and hematopoietic function tests) prior IBI308 administration
• Absolute neutrophil count (ANC) ≥1.5 x10^9/L
• Platelet count ≥ 100 x 10^9/L
• Hemoglobin ≥ 9 g / dL (whole blood or component transfusion within 7 days before 1st dose of study drug is prohibited)
• Renal function tests: serum creatinine ≤1.5 ×upper limit of normal range (ULN) or an estimated glomerular filtration rate (eGFR) ≥ 50 mL/min/1.73 m2
• Liver function tests alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3 x ULN, for patients with known liver cancer or liver metastases, AST and ALT ≤ 5 x ULN
• Total bilirubin (TBil) ≤1.5 x ULN; If Gilbert's Syndrome may have Bilirubin> 1.5 x ULN
• Coagulation tests: aPTT ≤ 1.5 x ULN and INR ≤2.0
• Cohort Specific Inclusion Criteria:

Cohort 1: Advanced/metastatic cancers with high TMB expression

i. Advanced/metastatic cancers with TMB level > 10 mut/Mb ii. Histologically or cytologically confirmed unresectable Stage III/IV NSCLC or other advanced/metastatic cancers (for example, melanoma, bladder cancer, SCLC, prostate cancer, colorectal cancer, gastric cancer) iiI. Separate informed consent is required for subjects who provide fresh biopsies for serial tumor biopsies for biomarker testing. TMB testing should be performed on the most recently obtained tumor sample.

v. Subjects must be tested for TMB level before entering the study, and pre-screen informed consent is required for TMB testing. Subjects who have existing FoundationOne TMB testing results from within 6 months of study entry do not need to have repeat testing.

vi. Refractory or intolerant to standard therapy or for whom no standard therapy exists. Subjects must have no available therapy likely to confer clinical benefit for their cancer. Subjects who experienced irAE grade ≥ 3, or grade 2 recurrent pneumonitis, or who had to discontinue prior anti-PD-1/PD-L1 treatment due to irAEs of any grade will not be eligible.

vi. NSCLC subjects with EGFR mutation and/or ALK rearrangement and/or ROS-1 positive, should have received appropriate targeted therapy and are refractory to targeted therapy prior to enrolling this trial.

Cohort 2: Advanced/metastatic endometrial Cancer i. Histologically confirmed advanced/metastatic endometrial cancer. ii. Refractory or intolerant to standard therapy, and no available therapy likely to confer clinical benefit for their cancer. Subjects who experienced irAE grade ≥ 3, or who had to discontinue prior anti-PD-1/PD-L1 treatment due to irAEs of any grade will not be eligible.

Exclusion Criteria

• Legal incapacity or limited legal capacity.
• Pregnanc