Phase I/II Study of SCTB39-1 in Advanced Solid Tumours

NCT ID: NCT07050641

Last Updated: 2025-07-04

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-23
• Study Completion Date: 2028-06-30

Brief Summary

This study aims to evaluate the safety, tolerability, PK characteristics, immunogenicity, and preliminary anti-tumor efficacy of SCTB39-1 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 Tumor

Study Design

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

Study Groups

SCTB39-1

SCTB39-1 of different doses, IV, every 3 weeks

Group Type: EXPERIMENTAL

SCTB39-1

Intervention Type: DRUG

SCTB39-1, IV

Interventions

SCTB39-1

SCTB39-1, IV

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Voluntarily sign the informed consent form (ICF);

2. Male or female, over 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. At least one measurable tumor lession according to RECIST v1.1;

8. 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 5 years prior to the enrollment;

3. Participants with brainstem, meningeal, spinal metastases, or compression; active central nervous system metastases;

4. Significant bleeding risk;

5. Presence of pleural effusion, peritoneal effusion, or ascites;

6. History of permanent discontinuation of immunotherapy due to immune-related toxicity or occurrence of ≥ Grade 3 irAEs;

7. Presence of any active autoimmune disease or a history of autoimmune disease with an expected recurrence;

8. History of severe allergies, severe drug allergies (including unapproved investigational drugs);

9. History of organ transplantation or stem cell transplantation;

10. Need for immunosuppressive drugs within 2 weeks prior to enrollment or anticipated during the study;

11. Received chemotherapy, immunotherapy, biologic therapy, or other anti-tumor treatments within 4 weeks before enrollment;

12. Pregnant or breastfeeding female.

• 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

Cancer Hospital Chinese Academy of Medical Science

Beijing, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Cuige Gao

Role: CONTACT

cuige_gao@sinocelltech.com

+86-10-58628288

Facility Contacts

Yu Hua

Role: primary

tsjj0082@chncro.com

+86-18810090438

Other Identifiers

SCTB39-1-X201

Identifier Type: -

Identifier Source: org_study_id