Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT07448922 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

A Study of SKB518 as Monotherapy or Combination Therapy in Patients With Advanced Gynecological Malignant Tumors

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Sponsor changed: Sichuan Kelun Pharmaceutical Research Institute Co., Ltd. to Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. Recruitment opened · Enrollment target: 290 to 280 · Study sites: 1 to 2 · 2 morev2 Show 5 more changesShow less
    • Recruitment opened
    • Enrollment target: 290 to 280
    • Study sites: 1 to 2
    • Start date changed from estimate of Mar 25, 2026 to Apr 8, 2026
    • Eligibility criteria expanded, about 5 words

    See this version in full on ClinicalTrials.gov ↗

  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07448922
Lead Sponsor Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
Conditions Advanced Gynecological Malignancies
Enrollment 280 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov