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

NCT06600022 | Recruiting Phase 1

• 1 other identifier: SCTB41-X101
• Study Type: interventional
• Target: 441
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Dose-Limiting toxicity(DLT)

  Incidence of dose-limiting toxicities up to the Day 21 visit

  :From Day 0 up to Day 21

• 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

Secondary Outcomes (3)

• Disease control rate (DCR)

  Up to 2 years

• Progression-free survival (PFS)

  Up to 2 years

• Overall survival (OS)

  Up to 2 years

Study Arms (1)

Arms

EXPERIMENTAL

SCTB41 of different doses,IV,every 3 weeks

Drug: SCTB41

Interventions

SCTB41 DRUG

SCTB41 of different doses,IV,every 3 weeks

Arms

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sinocelltech Ltd.: lead

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

RECRUITING

Central Study Contacts

xiaoman zhang

CONTACT

+86-10-58628288-9134; xiaoman_zhang@sinocelltech.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2024
• First Posted: September 19, 2024
• Study Start: October 10, 2024
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): April 30, 2028
• Last Updated: January 16, 2025

Record last verified: 2024-10

Locations

CN (1)