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.
Voluntarily sign the informed consent form (ICF);
Male or female, ≥18 years old;
Survival duration more than 3 months;
ECOG score ≤ 1 point;
Participants with brainstem, meningeal, spinal metastases, orcompression; active central nervous system metastases;
Other malignancies diagnosed;
History of hypertensive crisis or hypertensive encephalopathy; presence of uncontrolled hypertension. History of arterial thrombosis or deep veinthrombosis within 6 months prior to enrollment;
Presence of any active autoimmune disease or a history of autoimmunedisease with an expected recurrence;
Sequential
SCTB41
DrugSCTB41 of different doses,IV,every 3 weeks
Dose-Limiting toxicity(DLT)
Incidence of dose-limiting toxicities up to the Day 21 visit
Objective response rate (ORR)
The ORR is defined as the proportion of subjects with confirmed CR or confirmed PR, based on RECIST Version 1.1
Disease control rate (DCR)
The DCR is defined as the proportion of subjects with CR, PR, or SD based on RECIST Version 1.1.
Progression-free survival (PFS)
Progression-free survival is defined as the time from the start of treatment with SCTB41 until the first documentation ofdisease progression or death due to any cause, whichever occurs first.
Overall survival (OS)
Overall survival is defined as the time from the start of treatment with SCTB41 until death due to any cause.
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