A Phase II Clinical Trial Evaluating the Efficacy and Safety of SYS6026 Injection in Participants With HPV16 or 18-related High-grade Cervical Squamous Intraepithelial Lesions
NCT07702656 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 175
Last updated 2026-07-14
Summary
This trial is a multicenter, randomized, double-blind, placebo-controlled Phase II clinical study designed to evaluate the efficacy and safety of SYS6026 at different doses compared to placebo in treating patients with HPV16 or 18-related high-grade cervical squamous intraepithelial lesions (HSIL).
Conditions
- High-grade Cervical Intraepithelial Lesions
Interventions
- BIOLOGICAL
-
SYS6026
Administration continued until D168
- BIOLOGICAL
-
Administration continued until D168
Sponsors & Collaborators
-
CSPC Megalith Biopharmaceutical Co.,Ltd.
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-07-10
- Primary Completion
- 2028-09-30
- Completion
- 2028-12-30
Countries
- China
Study Locations
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