NCT06826040 SKB445 for Injection in Solid Tumors
| NCT ID | NCT06826040 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. |
| Condition | Advanced Solid Tumors |
| Study Type | INTERVENTIONAL |
| Enrollment | 126 participants |
| Start Date | 2025-02-05 |
| Primary Completion | 2026-12-31 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
This is a multicenter, open-label, multiple-dose dose finding and expansion study to evaluate the safety, tolerability, pharmacokinetic(PK) profile, and anti-tumor efficacy of SKB445 for injection in patients with advanced solid tumors.
Eligibility Criteria
Inclusion Criteria: 1. At the time of signing the ICF: age between 18 -75 years, male or female. 2. subjects with histologically or cytologically confirmed locally advanced or metastatic solid tumors who have failed/are intolerant/ineligible to or do not have standard therapy, and have at least one measurable lesion meeting Response Evaluation Criteria in Solid Tumors (RECIST v1.1). 3. Eastern Cooperative Oncology Group (ECOG) score of 0 to 1. 4. Expected survival ≥ 3 months. 5. Subjects with adequate organ and bone marrow function confirmed by laboratory results 6. Subjects of childbearing potential (male or female) must use effective medical contraception during the study 7. Ability to understand and willingness to sign ICF, and will be able to comply with the protocol-specified visits and relevant procedures. Exclusion Criteria: 1. Has received anti-tumor therapy, including chemotherapy, targeted therapy, tumor immunotherapy, and traditional Chinese medicinal products with anti-tumo