This study aims to explore the safety, tolerability, PK characteristics, immunogenicity, and preliminary anti-tumor efficacy of SCTB14 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 ≤ age ≤ 75 years old;
Survival duration more than 3 months;
ECOG score ≤ 1 point;
Participants with brainstem, meningeal, spinal metastases, or compression; active central nervous system metastases;
Other malignancies diagnosed within 5 years prior to the enrollment, except effectively treated malignant solid tumour (such as basal cell carcinoma of the skin, squamous cell carcinoma of the skin, cervical cancer in situ, breast cancer in situ, etc.);
History of hypertensive crisis or hypertensive encephalopathy; presence of uncontrolled hypertension. History of arterial thrombosis or deep vein thrombosis within 6 months prior to enrollmen;
Presence of any active autoimmune disease or a history of autoimmune disease with an expected recurrence;
Sequential
SCTB14
DrugSCTB14,IV
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 SCTB14 until the first documentation of disease 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 SCTB14 until death due to any cause.
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This trial is not recruiting at the moment. You can still explore other options:
