Aims to Explore the Safety, Tolerability, and Preliminary Efficacy of SCTB41 in Adult Patients with Advanced Malignant Solid Tumours.
A Phase I/II, Open-label, Multicentre, Dose-escalation, and Dose-expansion Study to Evaluate the Safety, Pharmacokinetics and Anti-tumor Activity of SCTB41 in Patients with Advanced Malignant Solid Tumours
Sinocelltech Ltd.
441 participants
Oct 10, 2024
INTERVENTIONAL
Conditions
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
Inclusion Criteria7
- 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 Criteria14
- 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.
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
SCTB41 of different doses,IV,every 3 weeks
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06600022