This is a first-in-human, non-randomized, open-label, multi-center, phase I study in patients with advanced solid tumor to evaluate the safety and tolerability, PK, immunogenicity, and preliminary anti-tumour activity of T320. This study consists of a dose escalation module and a backfill module. The trial process for each subject in both escalation and backfill module includes a screening period (28 days before the first T320 administration), a treatment period (from the first T320 administration to the end of reatment), a safety follow-up period (28 days after EOT/early withdrawal) and a progression follow-up period (every 12 weeks from safety follow-up visit). Patients will receive T320 administration once every 2 weeks (Q2W) and 28 days are set as one treatment cycle.
Voluntary to participate in the clinical study, sign a written informed consent form, and able to comply with clinical visits and study-related procedures.
Age ≥18 years old upon signing the informed consent form.
Have histologically and/or cytologically confirmed unresectable advanced solid tumour who are refractory to or intolerant of available standard-of-care therapy or have no effective standard treatment available.
ECOG performance score of 0 ~ 2.
Any anti-cancer therapy including chemotherapy, immunotherapy or anticancer agents within 3 weeks of the first dose of study treatment.
Known past or current coagulation defects leading to an increased risk of bleeding or any known bleeding diathesis.
History of Steven's Johnson's syndrome or Toxic Epidermal Necrolysis syndrome.
Known to be allergic to T320 for injection or any of its excipients, or patients with allergic constitution.