Phase I/II Study of SCTB39G in Advanced Solid Tumours

Not Applicable

Not yet recruiting

• Conditions: Advanced Malignant Solid Tumor
• Interventions: Drug: SCTB39G

• Registration Number: NCT07077252
• Lead Sponsor: Sinocelltech Ltd.

Brief Summary

This study aims to evaluate the safety, tolerability, PK characteristics, immunogenicity, and preliminary anti-tumor efficacy of SCTB39G 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-07
• Study First Submitted: 2025-07-11
• Study First Submitted QC: 2025-07-11
• Last Update Submitted: 2025-07-11
• Study First Posted: 2025-07-22
• Last Update Posted: 2025-07-22
• Study Start: 2025-07-28
• Primary Completion: 2027-09-26
• Study Completion: 2027-10-17

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• 1.Voluntarily sign the informed consent form (ICF);
• 2.Male or female, ≥ 18 years and ≤ 70 years old;
• 3.Survival duration more than 3 months;
• 4.ECOG score ≤ 1 point;
• 5.histologically or cytologically confirmed diagnosis of advanced malignant solid tumour；
• 6.At least one measurable tumor lession according to RECIST v1.1;
• 7.Adequate organ and bone marrow function.

Exclusion Criteria

• 1.Has participated in another clinical study within 4 weeks prior to the first dose;
• 2.Other malignancies diagnosed within 1 years prior to the enrollment;
• 3. Participants with brainstem, meningeal, spinal metastases, or compression; active central nervous system metastases;
• 4.NSCLC at high risk of bleeding; Obvious invasion of tumor into adjacent organs of esophageal lesions leads to high risk of bleeding or fistula,or participants after endotracheal stent implantation;
• 5.Participants with portal hypertension due to portal vein tumor thrombus at risk of bleeding;
• 6.Presence of pleural effusion, peritoneal effusion, or ascites;
• 7.Received chemotherapy, immunotherapy, biologic therapy, or other antitumor treatments within 4 weeks before enrollment
• 8.History of permanent discontinuation of immunotherapy due to immune-related toxicity or occurrence of ≥ Grade 3 irAEs;
• 9.Presence of any active autoimmune disease or a history of autoimmune disease with an expected recurrence;
• 10.History of severe allergies, severe drug allergies (including unapproved investigational drugs);
• 11.History of organ transplantation or stem cell transplantation;
• 12.Need for immunosuppressive drugs within 2 weeks prior to enrollment or anticipated during the study;
• 13.Pregnant or breastfeeding female.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SCTB39G	SCTB39G	SCTB39G of different doses, IV

Primary Outcome Measures

Name	Time	Method
Dose-Limiting toxicity(DLT)	From Day 0 up to Day 21	Incidence of dose-limiting toxicities up to the Day 21 visit
Objective response rate (ORR)	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 Outcome Measures

Name	Time	Method
Disease control rate (DCR)	Up to 2 years	The DCR is defined as the proportion of subjects with CR, PR, or SD based on RECIST Version 1.1.
Progression-free survival (PFS)	Up to 2 years	Progression-free survival is defined as the time from the start of treatment with SCTB39G until the first documentation of disease progression or death due to any cause, whichever occurs first.
Overall survival (OS)	Up to 2 years	Overall survival is defined as the time from the start of treatment with SCTB39G until death due to any cause.

Trial Locations

Locations (1)

Beijing Cancer Hospital; 🇨🇳 Beijing, Beijing, China