This is a multicenter, open-label, phase I dose-escalation and expansion study of IBI3026 in participants with unresectable, locally advanced, or metastatic solid tumors. The study will be conducted in two phases: Phase 1 dose escalation and Phase 2 dose expansion. Safety will be monitored by the Safety Review Committee (SRC).
Participants must have the ability to understand and sign a written informed consent form for participation in this study, including all assessments and procedures specified in the protocol;
Male or female participants aged ≥18 years;
At least one measurable lesion as defined by RECIST v1.1 within 28 days prior to the first dose of IBI3026;
ECOG performance status of 0-1;
Prior treatment with IL-12 class cytokines or IL-12 inhibitors;
Participation in any interventional clinical study other than observational (non-interventional) studies, or currently in the follow-up period of an interventional study;
Adverse reactions from prior anti-tumor therapies that have not resolved to Grade 0 or 1, or baseline levels, according to NCI CTCAE v5.0, prior to the first dose of study drug (exceptions include alopecia, fatigue, hyperpigmentation, or other conditions deemed without safety risk by the investigator);
Prior immune checkpoint inhibitor therapy associated with severe adverse reactions sufficient to compromise participant safety;
Single group
IBI3026
DrugRecombinant anti-programmed death receptor-1 (PD-1) antibody fused with interleukin-12 (IL-12) bispecific molecule injection
Adverse Event
Serious Adverse Event
Maximum Tolerated Dose
DLT(Dose-limiting Toxicity)
PK concentration: IBI3026 serum concentration
Incidence and number of patients with ADA
Incidence and number of patients with NAb
ORR (Objective Response Rate)
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