Actively Recruiting
Phase I/II Study of SCTB39-1 in Advanced Solid Tumours
Led by Sinocelltech Ltd. · Updated on 2025-07-04
110
Participants Needed
1
Research Sites
157 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study aims to evaluate the safety, tolerability, PK characteristics, immunogenicity, and preliminary anti-tumor efficacy of SCTB39-1 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
Phase I/II Study of SCTB39-1 in Advanced Solid Tumours
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily sign the informed consent form (ICF)
- Male or female, over 18 years old
- Survival duration more than 3 months
- ECOG score 1 point
- For Phase Ia: histologically or cytologically confirmed advanced malignant solid tumour
- For Phase Ib and II: histologically or cytologically confirmed specific type advanced malignant solid tumours
- At least one measurable tumor lesion according to RECIST v1.1
- Adequate organ and bone marrow function
You will not qualify if you...
- Participated in another clinical study within 4 weeks prior to the first dose
- Other malignancies diagnosed within 5 years prior to enrollment
- Brainstem, meningeal, spinal metastases, or compression; active central nervous system metastases
- Significant bleeding risk
- Presence of pleural effusion, peritoneal effusion, or ascites
- History of permanent discontinuation of immunotherapy due to immune-related toxicity or grade 3 irAEs
- Active autoimmune disease or history of autoimmune disease with expected recurrence
- History of severe allergies, severe drug allergies including unapproved investigational drugs
- History of organ or stem cell transplantation
- Need for immunosuppressive drugs within 2 weeks prior to enrollment or anticipated during study
- Received chemotherapy, immunotherapy, biologic therapy, or other anti-tumor treatments within 4 weeks before enrollment
- Pregnant or breastfeeding female
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Cancer Hospital Chinese Academy of Medical Science
Beijing, China
Actively Recruiting
Research Team
C
Cuige Gao
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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