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Clinical Trials in China / NCT07050641
Recruiting Phase 1/2

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

NCT07050641 · tracked via the Priya Life Science China tracker
Sponsor
Sinocelltech Ltd.
Phase
Phase 1/2
Started
2025-06-23
Last updated
2025-07-04

Condition(s) studied

Advanced Malignant Solid Tumor

Investigational drug(s) / intervention(s)

SCTB39-1

SCTB39-1: SCTB39-1, IV

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Cancer Hospital Chinese Academy of Medical Science Beijing China Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07050641 on ClinicalTrials.gov ↗ ← All trials in China