A Study of AK130 in Patients With Advanced Malignant Tumors

Inclusion criteria

• Written and signed informed consent and any locally required authorization obtained from the subject/legal representative.
• Eastern Cooperative Oncology Group (ECOG) Performance Score of 0 or 1.
• Life expectancy ≥3 months.
• Histologically or cytologically documented unresectable advanced or metastatic malignant tumor that has failed or intolerant of standard therapy, or for which no effective standard therapy is available.
• Subject must have at least one measurable lesion according to RECIST Version1.1.
• Adequate organ function.

Exclusion criteria

• Any malignancy other than the disease under study within the past 3 years except for radically cured local cancers, such as basal cell skin cancer, carcinoma in situ of the cervix, or carcinoma in situ of breast.
• Receipt of any anti-TIGIT, anti-TGF-β treatment.
• Experienced a toxicity that led to permanent discontinuation of prior immunotherapy. All AEs while receiving prior immunotherapy have not completely resolved or resolved to Grade 1 prior to screening, required the use of additional immunosuppression other than corticosteroids.
• Unresolved toxicities from prior anticancer therapy, defined as having not resolved to NCI CTCAE v5.0 Grade 0 or 1，or to levels dictated in the inclusion/exclusion criteria, except toxicities not considered a safety risk (e.g., alopecia, neuropathy, or asymptomatic laboratory abnormalities).
• Major surgical procedure within 4 weeks prior to the first dose of AK130 or still recovering from prior surgery.
• History of organ transplant.
• Known allergy or reaction to any component of the AK130 formulation. History of severe hypersensitivity reactions to other mAbs.