Evaluation of NWRD09 for Female Participants With Persistent HPV16 Infection (NCT07536282) | Clinical Trial Compass
Not Yet RecruitingPhase 1/2
Evaluation of NWRD09 for Female Participants With Persistent HPV16 Infection
United States78 participantsStarted 2026-10
Plain-language summary
This is a two-part, phase I/IIa study, intended to evaluate the safety, tolerability, immunogenicity, and efficacy of NWRD09 in female participants with persistent HPV16 infection, and to determine the MTD, and/or RP2D of NWRD09.
Who can participate
Age range18 Years – 60 Years
SexFEMALE
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Inclusion Criteria:
* Participants who have fully understood the study, able and willing to comply with all study procedures, and voluntarily sign written ICF;
* Female participants aged 18-60 years (inclusive) at the time of signing the ICF;
* Persistent HPV16 infection, defined as virologically confirmed HPV16 positivity persisting for ≥ 6 months before screening (e.g., participants must provide investigator-approved evidence of HPV16 infection ≥ 6 months prior to screening and be HPV16 positive at the time of screening);
* Participants must have a confirmed cytological results of atypical squamous cells cannot exclude high-grade squamous intraepithelial lesion (ASC-H) or high-grade squamous intraepithelial lesion (HSIL) at the time of screening (histopathological confirmed cervical/vaginal/vulvar LSIL are acceptable but not required);
* Satisfactory colposcopy at screening;
* Normal major organ functions at screening;
* Women of child-bearing potential must have a negative serum pregnancy test result at screening. All WOCBP participants agree to voluntarily use effective contraception, from signing the ICF to the end of the study. In addition, female participants must agree not to donate eggs during this period.
Exclusion Criteria:
* Histopathological confirmed high-grade cervical, vulvar, vaginal or anal intraepithelial lesions (including endocervical adenocarcinoma-in-situ \[AIS\]) or invasive cancer, OR cervical cytology results showing squamous cell carcinoma (SCC),…
What they're measuring
1
Incidence and severity of local and systemic adverse events (AEs).