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

NCT ID: NCT06600022

Last Updated: 2025-01-16

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 441 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-10
• Study Completion Date: 2028-04-30

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.

Conditions

Advanced Malignant Solid Tumours

Study Design

• Allocation Method: NA
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arms

SCTB41 of different doses,IV,every 3 weeks

Group Type: EXPERIMENTAL

SCTB41

Intervention Type: DRUG

SCTB41 of different doses,IV,every 3 weeks

Interventions

SCTB41

SCTB41 of different doses,IV,every 3 weeks

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sinocelltech Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

xiaoman zhang

Role: CONTACT

xiaoman_zhang@sinocelltech.com

+86-10-58628288-9134

Facility Contacts

Ruihua Xu, Professor

Role: primary

xurh@sysucc.org.cn

13922206676

Other Identifiers

SCTB41-X101

Identifier Type: -

Identifier Source: org_study_id