Actively Recruiting
Study to Evaluate Safety, Pharmacokinetics, and Anti-Tumor Activity of SCTB41 in Adults with Advanced Malignant Solid Tumours An Open-label, Dose-Escalation and Expansion Trial
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
Researchers are evaluating the safety, tolerability, pharmacokinetics, immune response, and early anti-tumor effects of SCTB41 as a single treatment in adults with advanced malignant solid tumors. This open-label, multicenter study is a Phase I/II clinical trial involving dose-escalation and dose-expansion phases to better understand how SCTB41 works and its effects at various doses. Participants receive SCTB41 intravenously at different doses every three weeks during the study. The trial includes a dose-escalation phase to determine safe dosage levels followed by a dose-expansion phase to further assess the treatment's activity in specific tumor types. Treatment continues as per protocol, allowing researchers to observe responses and monitor safety. Throughout the study, participants undergo assessments to track safety, side effects, drug behavior in the body, and tumor response. Key outcomes include measuring dose-limiting toxicities within 21 days and objective response rates over up to two years. Participants are monitored for organ function, immune reactions, and overall health to ensure safety and gather comprehensive data on SCTB41's impact.
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
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here