Recruiting NCT06600022
Aims to Explore the Safety, Tolerability, and Preliminary Efficacy of SCTB41 in Adult Patients with Advanced Malignant Solid Tumours.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: SCTB41.
- Who it may be relevant to
- Registry conditions: Advanced Malignant Solid Tumours. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
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.
Interventions
- Drug SCTB41
SCTB41 of different doses,IV,every 3 weeks
Primary outcome measures
- Dose-Limiting toxicity(DLT) [Time frame: :From Day 0 up to Day 21]
- Objective response rate (ORR) [Time frame: Up to 2 years]
Secondary outcome measures (3)
- Disease control rate (DCR) [Time frame: Up to 2 years]
- Progression-free survival (PFS) [Time frame: Up to 2 years]
- Overall survival (OS) [Time frame: Up to 2 years]
Eligibility criteria
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;
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Sun Yat-sen University Cancer Center — Guangzhou
Identifiers
NCT: NCT06600022 · SCTB41-X101