NCT06600022
Recruiting
Phase 1
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
Overview
- Phase
- Phase 1
- Status
- Recruiting
- Sponsor
- Sinocelltech Ltd.
- Enrollment
- 441
- Locations
- 1
- Primary Endpoint
- Dose-Limiting toxicity(DLT)
Overview
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 tumours. This study is an open label, multicentre, dose-escalation and dose-expansion Phase I/II clinical trial.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Sequential
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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 Criteria
- •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;
Arms & Interventions
Arms
Experimental
SCTB41 of different doses,IV,every 3 weeks
Intervention: SCTB41 (Drug)
Outcomes
Primary Outcomes
Dose-Limiting toxicity(DLT)
Time Frame: :From Day 0 up to Day 21
Incidence of dose-limiting toxicities up to the Day 21 visit
Objective response rate (ORR)
Time Frame: Up to 2 years
The ORR is defined as the proportion of subjects with confirmed CR or confirmed PR, based on RECIST Version 1.1
Secondary Outcomes
- Disease control rate (DCR)(Up to 2 years)
- Overall survival (OS)(Up to 2 years)
- Progression-free survival (PFS)(Up to 2 years)
Investigators
Study Sites (1)
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