Status:
RECRUITING
Aims to Explore the Safety, Tolerability, and Preliminary Efficacy of SCTB41 in Adult Patients with Advanced Malignant Solid Tumours.
Lead Sponsor:
Sinocelltech Ltd.
Conditions:
Advanced Malignant Solid Tumours
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- Voluntarily sign the informed consent form (ICF);
- Male or female, ≥18 years old;
- Survival duration more than 3 months;
- ECOG score ≤ 1 point;
- Participants in Phase Ia (dose-escalation phase) are required to meet the following criteria: histologically or cytologically confirmed diagnosis of advanced malignant solid tumour;
- Participants in Phase Ib (dose-expansion phase) and Phase II are required to meet the following criteria: Histologically or cytologically confirmed specific type advanced malignant solid tumours;
- Adequate organ and bone marrow function.
Exclusion
- Participants with brainstem, meningeal, spinal metastases, orcompression; active central nervous system metastases;
- Other malignancies diagnosed;
- History of hypertensive crisis or hypertensive encephalopathy; presence of uncontrolled hypertension. History of arterial thrombosis or deep veinthrombosis within 6 months prior to enrollment;
- Presence of any active autoimmune disease or a history of autoimmunedisease with an expected recurrence;
- Received chemotherapy, immunotherapy, biologic therapy, or other antitumor treatments within 4 weeks before enrollment;
- Need for immunosuppressive drugs within 2 weeks prior to enrollment oranticipated during the study;
- Significant coagulopathy or other evident risk of bleeding;
- uncontrolled effusions in the serous cavities within 4 weeks before enrollment；
- Major surgery or significant trauma within 4 weeks prior to enrollment;presence of unhealed skin wounds, surgical sites, trauma sites, severe- Page 3 of 4 \[DRAFT\] -mucosal ulcers, or fractures, or if the Investigator deems the participantunsuitable for the study;
- History of permanent discontinuation of immunotherapy due to immunerelated toxicity or occurrence of ≥ Grade 3 irAEs;
- Known severe allergy to similar antibody drugs;
- Presence of active infection；
- History of organ transplantation or stem cell transplantation;
- Pregnant or breastfeeding female; women of childbearing potential withpositive pregnancy test within 7 days before the enrollment; participants(including males of childbearing potential and their female partners, and females of childbearing potential and their male partners) unwilling to use medically recognized effective contraception during the study and for 6 months after treatment ends.
Key Trial Info
Start Date :
October 10 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2028
Estimated Enrollment :
441 Patients enrolled
Trial Details
Trial ID
NCT06600022
Start Date
October 10 2024
End Date
April 30 2028
Last Update
January 16 2025
Active Locations (1)
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1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060