SCTB41 Plus SCTB39G With or Without Standard Therapy in Advanced Solid Tumors

An Open Multi-center Phase I/II Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of SCTB41 in Combination With SCTB39G With or Without Standard Therapy in Adult Patients With Advanced Malignant Solid Tumors

This study aims to evaluate the safety, tolerability, PK characteristics, immunogenicity, and preliminary anti-tumor efficacy of SCTB41 in combination with SCTB39G with or without standard therapy in adult patients with advanced malignant solid tumors. This study is an open label, multicentre, dose-escalation and dose-expansion Phase I/II clinical trial.

Inclusion Criteria:

1. Voluntarily sign the informed consent form (ICF);
2. Male or female, ≥ 18 years and ≤ 75 years old;
3. Survival duration more than 3 months;
4. ECOG score ≤ 1 point;
5. Histologically or cytologically confirmed diagnosis of advanced malignant solid tumor；
6. At least one measurable tumor lesion according to RECIST v1.1;
7. Adequate organ and bone marrow function.

Exclusion Criteria:

1. Has participated in another clinical study within 4 weeks prior to the first dose;
2. Has previously received other immunotherapies other than PD-(L)1 inhibitors；
3. Other malignancies diagnosed within 5 years prior to the enrollment;
4. Participants with brainstem, meningeal, spinal metastases, or compression; active central nervous system metastases;
5. Significant bleeding risk;
6. Presence of pleural effusion, peritoneal effusion, or ascites;
7. Received chemotherapy, immunotherapy, biologic therapy, or other antitumor treatments within 4 weeks before enrollment；
8. History of permanent discontinuation of immunotherapy due to immune-related toxicity or occurrence of ≥ Grade 3 irAEs;
9. Presence of any active autoimmune disease or a history of autoimmune disease with an expected recurrence;
10. History of severe allergies, severe drug allergies (including unapproved investigational drugs);
11. History of organ transplantation or stem cell transplantation;
12. Need for immunosuppressive drugs within 2 weeks prior to enrollment or anticipated during the study;
13. Pregnant or breastfeeding female.