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Evaluation of NWRD08 for HPV-16 and/or HPV-18 Related Cervical HSIL

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Oct 10, 2025 to Nov 11, 2025
    • Site details revised at 5 of 5 sites
    v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 a randomized, double-blind, placebo controlled Phase 2 study to determine the efficacy and safety of NWRD08 administered by intramuscular (IM) injection followed by electroporation (EP) in adult women with histologically confirmed cervical high grade squamous intraepithelial lesion (HSIL) (cervical intraepithelial neoplasia grade 2 \[CIN2\] or grade 3 \[CIN3\]) associated with human papillomavirus (HPV) 16 and/or HPV18.
Trial Details
NCT Number NCT07175662
Lead Sponsor Newish Biotech (Wuxi) Co., Ltd.
Conditions
(from sponsor)		 High-grade Squamous Intraepithelial Lesion (HSIL)
Related terms Squamous Intraepithelial Lesions
Enrollment 150 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov