NCT06725381 A Phase 1 Study of SKB571 in Subjects With Advanced Solid Tumors
| NCT ID | NCT06725381 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. |
| Condition | Solid Malignancies |
| Study Type | INTERVENTIONAL |
| Enrollment | 138 participants |
| Start Date | 2024-12-17 |
| Primary Completion | 2026-12 |
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 138 participants in total. It began in 2024-12-17 with a primary completion date of 2026-12.
⚠ 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 is a first-in-human (FIH), phase 1, multicenter, open-label study of SKB571 to evaluate the safety, tolerability, PK, immunogenicity, and antitumor activity in adult subjects with advanced or metastatic solid tumor .
Eligibility Criteria
Inclusion Criteria: 1. Subjects aged 18-75 years at the time of signing the informed consent form 2. Subjects with histologically or cytologically confirmed locally advanced or metastatic solid tumors . 3. Subjects with at least one measurable lesion assessed by the investigator according to RECIST v1.1. 4. Subjects with Eastern Cooperative Oncology Group (ECOG) status score of 0 or 1. 5. Subjects who are assessed by the investigator to have an expected survival of ≥ 3 months. 6. Subjects who have adequate organ function. 7. Subjects who have recovered from all toxicities due to prior therapy . 8. Male and female subjects must agree to use highly effective contraception methods during the study treatment. 9. Subjects who voluntarily sign the informed consent form. Exclusion Criteria: 1. Subjects with known active or untreated central nervous system (CNS) metastases. 2. Subjects with other malignant tumors within 3 years prior to the first dose. 3. Subjects with history of major cardiovascular, cerebrovascular, or thromboembolic disease. 4. Subjects with known active pulmonary tuberculosis. 5. Subjects with human immunodeficiency virus (HIV) infection, or any known active viral hepatitis, or hepatitis B or hepatitis C. 6. Subjects with major surgery within 28 days prior to the first dose. 7. Subjects with known allergy or hypersensitivity to SKB571 or its excipients. 8. Subjects with clinically severe lung injuries due to pulmonary complications. 9. Subjects with a history of allogeneic tissue/solid organ transplant. 10. Uncontrolled pleural effusion, pericardial effusion, or ascites effusion requiring repeated drainage. 11. Subjects who have received live vaccines within 30 days prior to the first dose of study treatment, or who are scheduled to receive live vaccines during the study. 12. Subjects who have received strong cytochrome P450 (CYP3A4) inhibitors or inducers, or BCRP inhibitors within 2 weeks prior to the first dose of study treatment or within 5 half-lives of known drug, whichever is longer. 13. Subjects who have received chemotherapy, immunotherapy, or biological therapy within 4 weeks prior to the first dose of study treatment. 14. Subjects with active infection requiring systemic anti-infective therapy within 14 days prior to the first dose of study treatment. 15. Subjects with any disease requiring systemic treatment with corticosteroids (prednisone at doses \> 10 mg/d or similar drugs with equivalent doses) or other immunosuppressive therapy within 14 days prior to the first dose of study treatment. 16. Subjects have received an investigational agent or has used an investigational device within 28 days prior to initial dose administration of SKB571. 17. Subjects whose condition deteriorates rapidly before the first dose, such as a severe physical impariment or a change in ECOG score no longer meeting the inclusion criteria. 18. Subjects with a known history of psychosis or drug abuse that will preclude the subject from completing the study. 19. Any condition that, in the opinion of the investigator, will interfere with the assessment of study treatment or the safety of the subject or the interpretation of the study results.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06725381 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Solid Malignancies. 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 NCT06725381 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 NCT06725381 currently recruiting?
Yes, NCT06725381 is actively recruiting participants. Contact the research team at lixin@kelun.com for enrollment information.
Where is the NCT06725381 trial being conducted?
This trial is being conducted at Guangzhou, China, Nanning, China, Wuhan, China, Changsha, China and 11 additional locations.
Who is sponsoring the NCT06725381 clinical trial?
NCT06725381 is sponsored by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.. The trial plans to enroll 138 participants.