Trials / Not Yet Recruiting
Not Yet RecruitingNCT07448922
A Study of SKB518 as Monotherapy or Combination Therapy in Patients With Advanced Gynecological Malignant Tumors
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
- Status
- Not Yet Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 290 (estimated)
- Sponsor
- Sichuan Kelun Pharmaceutical Research Institute Co., Ltd. · Industry
- Sex
- Female
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | SKB518 for injection | SKB518 12mg/kg q3w |
| DRUG | Carboplatin (AUC 5) | AUC 5 q3w |
| DRUG | Bevacizumab | Bevacizumab 15mg/kg q3w |
| DRUG | SKB518 for injection | SKB518 10mg/kg q3w |
Timeline
- Start date
- 2026-03-25
- Primary completion
- 2027-12-31
- Completion
- 2028-09-30
- First posted
- 2026-03-04
- Last updated
- 2026-03-04
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT07448922. Inclusion in this directory is not an endorsement.