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Clinical Trials in China / NCT06600022
Recruiting Phase 1/2

Aims to Explore the Safety, Tolerability, and Preliminary Efficacy of SCTB41 in Adult Patients with Advanced Malignant Solid Tumours.

NCT06600022 · tracked via the Priya Life Science China tracker
Sponsor
Sinocelltech Ltd.
Phase
Phase 1/2
Started
2024-10-10
Last updated
2025-01-16

Condition(s) studied

Advanced Malignant Solid Tumours

Investigational drug(s) / intervention(s)

SCTB41

SCTB41: SCTB41 of different doses,IV,every 3 weeks

Study 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 tumours. This study is an open label, multicentre, dose-escalation and dose-expansion Phase I/II clinical trial.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: 1. Voluntarily sign the informed consent form (ICF); 2. Male or female, ≥18 years old; 3. Survival duration more than 3 months; 4. ECOG score ≤ 1 point; 5. Participants in Phase Ia (dose-escalation phase) are required to meet the following criteria: histologically or cytologically confirmed diagnosis of advanced malignant solid tumour; 6. 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; 7. Adequate organ and bone marrow function. Exclusion Criteria: 1. Participants with brainstem, meningeal, spinal metastases, orcompression; active central nervous system metastases; 2. Other malignancies diagnosed; 3. History of hypertensive crisis or hypertensive encephalopathy; presence of uncontrolled hypertension. History of arterial thrombosis or deep veinthrombosis within 6 months prior to enrollment; 4. Presence of any active autoimmune disease or a history of autoimmunedisease with an expected recurrence; 5. Received chemotherapy, immunotherapy, biologic therapy, or other antitumor treatments within 4 weeks before enrollment; 6. Need for immunosuppressive drugs within 2 weeks prior to enrollment oranticipated during the study; 7. Significant coagulopathy or other evident risk of bleeding; 8. uncontrolled effusions in the serous cavities within 4 weeks before enrollment; 9. 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; 10. History of permanent discontinuation of immunotherapy due to immunerelated toxicity or occurrence of ≥ Grade 3 irAEs; 11. Known severe allergy to similar antibody drugs; 12. Presence of active infection; 13. History of organ transplantation or stem cell transplantation; 14. 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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Sun Yat-sen University Cancer Center Guangzhou Guangdong Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06600022 on ClinicalTrials.gov ↗ ← All trials in China