Phase I/II Study of SCTB41 Plus SCTB39-1with or Without Standard Therapy in Advanced Solid Tumours

An Open Multi-center Phase I/II Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of SCTB41 in Combination With SCTB39-1With or Without Standard Therapy in Adult Patients With Advanced Malignant Solid Tumours

This study aims to evaluate the safety, tolerability, PK characteristics, immunogenicity, and preliminary anti-tumor efficacy of SCTB41 in combination with SCTB39-1with or without standard therapy 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: Not yet recruiting
• Conditions: Advanced Malignant Solid Tumor
• Intervention / Treatment: Drug: SCTB41+SCTB39-1

• Study Type: Interventional
• Enrollment (Estimated): 126
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Dongyang Gao, Doctor; Phone Number: +86-010-58628288; Email: dongyang_gao@sinocelltech.com

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 and ≤ 75 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. Has previously received other immunotherapies other than PD-(L)1 inhibitors；
3. Other malignancies diagnosed within 5 years prior to the enrollment;
4. Participants with brainstem, meningeal, spinal metastases, or compression; active central nervous system metastases;
5. Significant bleeding risk;
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 Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SCTB41+SCTB39-1; SCTB41 plus SCTB39-1 of different doses, IV, every 3 weeks	Drug: SCTB41+SCTB39-1; SCTB41 plus SCTB39-1 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
Overall survival (OS)	Overall survival is defined as the time from the start of treatment until death due to any cause.	Up to 2 years
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)	The PFS is defined as the time from the start of treatment until the first documentation of disease progression or death due to any cause, whichever occurs first.	Up to 2 years

Collaborators and Investigators

• Sponsor: Sinocelltech Ltd.
• Investigators: Principal Investigator: jiang, Cancer Hospital Chinese Academy of Medical Science Recruiting Beijing, China

Study record dates

Study Major Dates

• Study Start (Estimated): May 30, 2026
• Primary Completion (Estimated): May 30, 2029
• Study Completion (Estimated): May 30, 2029

Study Registration Dates

• First Submitted: May 11, 2026
• First Submitted That Met QC Criteria: May 11, 2026
• First Posted (Actual): May 18, 2026

Study Record Updates

• Last Update Posted (Actual): May 18, 2026
• Last Update Submitted That Met QC Criteria: May 11, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: advanced malignant solid tumor
• Other Study ID Numbers: SCTB41-B39-1-X201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No