Evaluation of NWRD08 for HPV-16 and/or HPV-18 Related Cervical HSIL (NCT07175662) | Clinical Trial Compass
RecruitingPhase 2
Evaluation of NWRD08 for HPV-16 and/or HPV-18 Related Cervical HSIL
China150 participantsStarted 2025-11-11
Plain-language summary
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.
Who can participate
Age range18 Years – 60 Years
SexFEMALE
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Inclusion criteria
✓. The colposcopy must be satisfactory, allowing clear visualization of the entire acetowhite area or the extent of suspected cervical intraepithelial neoplasia (CIN) lesions, including the upper border of the lesion.
✓. If the upper border of the lesion is unclear, endocervical curettage (ECC) results must be negative.
✓. The cervical lesion area must be less than 75% of the surface of the ectocervix.
✓. Hormonal contraceptives: Combined or progestin-only methods, including oral contraceptives, injections, implants, vaginal rings, or transdermal patches. Subjects with a history of hypercoagulable states (e.g., deep vein thrombosis, pulmonary embolism) must not use hormonal contraceptives.
✓. Abstinence from penile-vaginal intercourse.
✓. Intrauterine device (IUD) or intrauterine system (IUS).
✓. Female subject's male partner sterilized for at least 6 months prior to study entry, and this male is the subject's sole sexual partner.
✓. Condom use, with emergency contraception required in case of accidents such as slippage or breakage.
Exclusion criteria
✕. Any histopathologically confirmed cervical adenocarcinoma/adenocarcinoma in situ (AIS), high-grade vulvar, vaginal, or anal intraepithelial lesions or invasive cancer.
✕. Female participants who are pregnant, breastfeeding, or planning to become pregnant during the study.
What they're measuring
1
Proportion of Participants with Histopathological Regression of Cervical Lesions to CIN 1 or no lesions at week 36