Actively Recruiting
Aims to Explore the Safety, Tolerability, and Preliminary Efficacy of SCTB41 in Adult Patients with Advanced Malignant Solid Tumours.
Led by Sinocelltech Ltd. · Updated on 2025-01-16
441
Participants Needed
1
Research Sites
185 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Aims to Explore the Safety, Tolerability, and Preliminary Efficacy of SCTB41 in Adult Patients with Advanced Malignant Solid Tumours.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily sign the informed consent form
- Male or female aged 18 years or older
- Expected survival longer than 3 months
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- For Phase Ia: histologically or cytologically confirmed advanced malignant solid tumor
- For Phase Ib and Phase II: histologically or cytologically confirmed specific types of advanced malignant solid tumors
- Adequate organ and bone marrow function
You will not qualify if you...
- Brainstem, meningeal, spinal metastases or compression; active central nervous system metastases
- Diagnosis of other malignancies
- History of hypertensive crisis or encephalopathy; uncontrolled hypertension; arterial or deep vein thrombosis within 6 months prior to enrollment
- Active autoimmune disease or history of autoimmune disease with expected recurrence
- Chemotherapy, immunotherapy, biologic therapy, or other anti-tumor treatments within 4 weeks prior to enrollment
- Need for immunosuppressive drugs within 2 weeks prior to enrollment or anticipated during the study
- Significant coagulopathy or bleeding risk
- Uncontrolled effusions in serous cavities within 4 weeks prior to enrollment
- Major surgery or significant trauma within 4 weeks prior to enrollment; unhealed wounds or severe ulcers
- History of permanent discontinuation of immunotherapy due to immune-related toxicity or grade 3 or higher immune-related adverse events
- Known severe allergy to similar antibody drugs
- Active infection
- History of organ or stem cell transplantation
- Pregnant or breastfeeding; women of childbearing potential with positive pregnancy test within 7 days prior to enrollment; unwillingness to use effective contraception during and for 6 months after treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Actively Recruiting
Research Team
X
xiaoman zhang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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