Aims to Explore the Safety, Tolerability, and Preliminary Efficacy of SCTB41 in Adult Patients with Advanced Malignant Solid Tumours.
Trial Parameters
Brief Summary
This study aims to explore the safety, tolerability, PK characteristics, immunogenicity, and preliminary anti-tumor efficacy of SCTB41 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 Criteria
Inclusion Criteria: 1. Voluntarily sign the informed consent form (ICF); 2. Male or female, ≥18 years old; 3. Survival duration more than 3 months; 4. ECOG score ≤ 1 point; 5. Participants in Phase Ia (dose-escalation phase) are required to meet the following criteria: histologically or cytologically confirmed diagnosis of advanced malignant solid tumour; 6. 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; 7. Adequate organ and bone marrow function. Exclusion Criteria: 1. Participants with brainstem, meningeal, spinal metastases, orcompression; active central nervous system metastases; 2. Other malignancies diagnosed; 3. History of hypertensive crisis or hypertensive encephalopathy; presence of uncontrolled hypertension. History of arterial thrombosis or deep veinthrombosis within 6 months prior to enrollment; 4. Presence of any active autoi