drugset / Trial / NCT07448922
A Study of SKB518 as Monotherapy or Combination Therapy in Patients With Advanced Gynecological Malignant Tumors
Non-randomizedParallel-groupOpen-labelTreatment
Summary
This is an open-label, multicenter, Phase II clinical study to evaluate the efficacy and safety of SKB518 as monotherapy or combination therapy in patients with advanced gynecological malignancies. This study will include 5 cohorts: SKB518 as monotherapy in advanced ovarian cancer; SKB518 as monotherapy in advanced cervical cancer and endometrial cancer; SKB518 in combination with Carboplatin in advanced ovarian cancer; SKB518 in combination with Carboplatin and Bevacizumab in advanced ovarian cancer; and SKB518 in combination with Bevacizumab in advanced ovarian cancer. Study hypothesis: SKB518 will show meaningful clinical activity and a favorable risk benefit profile in gynecological malignancies.
Timeline
- Start
- 2026-04-08
- Primary completion
- 2027-12-31
- Completion
- 2028-09-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bevacizumab | Monoclonal antibody | 15 mg/kg | — |
| Subject | Carboplatin | Small molecule | — | — |
| Subject | SKB518 | Unknown | 10 mg/kg | — |
| Subject | SKB518 | Unknown | 12 mg/kg | — |