Overview
This study aims to evaluate the safety, tolerability, PK characteristics, immunogenicity, and preliminary anti-tumor efficacy of SCTB39-1 as a monotherapy in adult patients with advanced malignant solid tumours. This study is an open label, multicentre, dose-escalation and dose-expansion Phase I/II clinical trial.
Eligibility
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.