Phase I/II Study of SCTB39-1 in Advanced Solid Tumours

Inclusion criteria

• Voluntarily sign the informed consent form (ICF);
• Male or female, over 18 years old;
• Survival duration more than 3 months;
• ECOG score ≤ 1 point;
• Participants in Phase Ia (dose-escalation phase) are required to meet the following criteria: histologically or cytologically confirmed diagnosis of advanced malignant solid tumour;
• Participants in Phase Ib (dose-expansion phase) and Phase II are required to meet the following criteria: Histologically or cytologically confirmed specific type advanced malignant solid tumours;
• At least one measurable tumor lession according to RECIST v1.1;
• Adequate organ and bone marrow function.

Exclusion criteria

• Has participated in another clinical study within 4 weeks prior to the first dose;
• Other malignancies diagnosed within 5 years prior to the enrollment;
• Participants with brainstem, meningeal, spinal metastases, or compression; active central nervous system metastases;
• Significant bleeding risk;
• Presence of pleural effusion, peritoneal effusion, or ascites;
• History of permanent discontinuation of immunotherapy due to immune-related toxicity or occurrence of ≥ Grade 3 irAEs;
• Presence of any active autoimmune disease or a history of autoimmune disease with an expected recurrence;
• History of severe allergies, severe drug allergies (including unapproved investigational drugs);
• History of organ transplantation or stem cell transplantation;
• Need for immunosuppressive drugs within 2 weeks prior to enrollment or anticipated during the study;
• Received chemotherapy, immunotherapy, biologic therapy, or other anti-tumor treatments within 4 weeks before enrollment;
• Pregnant or breastfeeding female.