About this trial
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.
Eligibility criteria
Qualifiers
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;
Disqualifiers
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;
Trial design
Treatments tested in this trial
- SCTB14