Phase I/II Study of SCTB41 Plus SCTB39-1with or Without Standard Therapy in Advanced Solid Tumours
Starting soon · Phase 1/Phase 2
Conditions studied: Advanced Malignant Solid Tumor
In brief
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.
Key facts
- Study ID
- NCT07594028
- Run by
- Sinocelltech Ltd.
- People needed
- 126
- Starts
- 2026-05-30
- Expected to finish
- 2029-05-30
- Last updated by the study team
- 2026-05-18
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Voluntarily sign the informed consent form (ICF);
- Male or female, ≥ 18 years and ≤ 75 years old;
- Survival duration more than 3 months;
- ECOG score ≤ 1 point;
- histologically or cytologically confirmed diagnosis of advanced malignant solid tumour；
- At least one measurable tumor lession according to RECIST v1.1;
- Adequate organ and bone marrow function.
You may not qualify if…
- Has participated in another clinical study within 4 weeks prior to the first dose;
- Has previously received other immunotherapies other than PD-(L)1 inhibitors；
- Other malignancies diagnosed within 5 years prior to the enrollment;
- Participants with brainstem, meningeal, spinal metastases, or compression; active central nervous system metastases;
- Significant bleeding risk;
- Presence of pleural effusion, peritoneal effusion, or ascites;
- Received chemotherapy, immunotherapy, biologic therapy, or other antitumor treatments within 4 weeks before enrollment；
- History of permanent discontinuation of immunotherapy due to immune-related toxicity or occurrence of ≥ Grade 3 irAEs;
- Presence of any active autoimmune disease or a history of autoimmune disease with an expected recurrence;
- History of severe allergies, severe drug allergies (including unapproved investigational drugs);
- History of organ transplantation or stem cell transplantation;
- Need for immunosuppressive drugs within 2 weeks prior to enrollment or anticipated during the study;
- Pregnant or breastfeeding female.
Full record on ClinicalTrials.gov
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