An Open-label Phase 1b Multicenter Study of IBI308 in Subjects With Advanced/Metastatic Solid Malignancies

Inclusion Criteria
Subjects (males and females) of childbearing potential should be willing to use reliable contraception methods that are deemed effective by the investigator 1 month prior to treatment and throughout the treatment period and for 90 days following the last dose of study drug. Postmenopausal women must have been amenorrheal for at least 12 months to be considered of non-childbearing potential.
At least one measurable lesion
Subjects with life expectancy of greater than or equal to 3 months
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
Exclusion Criteria
Legal incapacity or limited legal capacity
Pregnancy, lactation, breastfeeding
Concurrent anticancer treatment (e.g., cytoreductive therapy or cytokine therapy except for erythropoietin) or use of other investigational product within 28 days before start of trial treatment; major surgery within 28 days before start of trial treatment (excluding prior diagnostic biopsy
Note: Small molecule or antibody targeted therapy 3 weeks from start of trial treatment will be excluded.
Received a biologic (G-CSF, GM-CSF) within 14 days prior to the first dose of study drug
Vaccination within 4 weeks of first dose of IBI308 and while on study except for administration of inactivated vaccines (e.g., inactivated influenza vaccines)
Failure to recover from adverse events from the most recent anti-tumor treatment to CTCAE less than or equal to grade 1 or baseline with the exception of alopecia
Active autoimmune disease requiring systemic treatment within the past 1 year or a documented history of clinically severe autoimmune disease or a syndrome that requires systemic steroids or immunosuppressive agents during the conduct of this study. Exceptions: - Vitiligo, eczema, psoriasis (10 mg/day prednisone or equivalents) for at least 2 weeks prior to treatment are not eligible.
Severe or uncontrolled cardiac disease requiring treatment, congestive heart failure (New York Heart Association) NYHA III or IV, unstable angina pectoris even if medically controlled, history of myocardial infarction during the last 3 months, serious arrhythmias requiring medication (with exception of atrial fibrillation or paroxysmal supraventricular tachycardia).
Any other serious underlying medical (e.g., uncontrolled hypertension, active uncontrolled infection, active gastric ulcer, uncontrolled seizures, cerebrovascular incidents, gastrointestinal bleeding, severe signs and symptoms of coagulation and clotting disorders, other serious cardiac conditions not listed in exclusion criteria), psychiatric, psychological, familial or geographical condition that, in the judgment of the investigator, may interfere with the planned staging, treatment and follow-up, affect patient compliance or place the patient at high risk from treatment-related complications.