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

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 Overview

• Status: Recruiting
• Conditions: Advanced Malignant Solid Tumours
• Intervention / Treatment: Drug: SCTB41

• Study Type: Interventional
• Enrollment (Estimated): 441
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: xiaoman zhang; Phone Number: +86-10-58628288-9134; Email: xiaoman_zhang@sinocelltech.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510060
      • Recruiting
      • Sun Yat-sen University Cancer Center
      • Contact: Ruihua Xu, Professor; Phone Number: 13922206676; Email: xurh@sysucc.org.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arms; SCTB41 of different doses,IV,every 3 weeks	Drug: SCTB41; SCTB41 of different doses,IV,every 3 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective response rate (ORR)	The ORR is defined as the proportion of subjects with confirmed CR or confirmed PR, based on RECIST Version 1.1	Up to 2 years
Dose-Limiting toxicity(DLT)	Incidence of dose-limiting toxicities up to the Day 21 visit	:From Day 0 up to Day 21

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease control rate (DCR)	The DCR is defined as the proportion of subjects with CR, PR, or SD based on RECIST Version 1.1.	Up to 2 years
Progression-free survival (PFS)	Progression-free survival is defined as the time from the start of treatment with SCTB41 until the first documentation ofdisease progression or death due to any cause, whichever occurs first.	Up to 2 years
Overall survival (OS)	Overall survival is defined as the time from the start of treatment with SCTB41 until death due to any cause.	Up to 2 years

Collaborators and Investigators

• Sponsor: Sinocelltech Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): October 10, 2024
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): April 30, 2028

Study Registration Dates

• First Submitted: September 12, 2024
• First Submitted That Met QC Criteria: September 12, 2024
• First Posted (Actual): September 19, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 14, 2025
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: SCTB41-X101

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No