NCT07050641 Phase I/II Study of SCTB39-1 in Advanced Solid Tumours
| NCT ID | NCT07050641 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Sinocelltech Ltd. |
| Condition | Advanced Malignant Solid Tumor |
| Study Type | INTERVENTIONAL |
| Enrollment | 110 participants |
| Start Date | 2025-06-23 |
| Primary Completion | 2028-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 110 participants in total. It began in 2025-06-23 with a primary completion date of 2028-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07050641 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Advanced Malignant Solid Tumor. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07050641 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07050641 currently recruiting?
Yes, NCT07050641 is actively recruiting participants. Contact the research team at cuige_gao@sinocelltech.com for enrollment information.
Where is the NCT07050641 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT07050641 clinical trial?
NCT07050641 is sponsored by Sinocelltech Ltd.. The trial plans to enroll 110 participants.