A Study in Subjects With Human Papillomavirus 16 or 18 Associated Cervical Intraepithelial Neopla… (NCT06273553) | Clinical Trial Compass
Not Yet RecruitingPhase 1/2
A Study in Subjects With Human Papillomavirus 16 or 18 Associated Cervical Intraepithelial Neoplasia Grade 2 or 3
39 participantsStarted 2024-03
Plain-language summary
The purpose of this study is to to evaluate the safety, tolerability, immunogenicity, and efficacy of RG002 Injection in subjects with HPV16/18 associated Cervical Intraepithelial Neoplasia Grade 2 or 3(CIN2/3).
Who can participate
Age range18 Years – 55 Years
SexFEMALE
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Inclusion criteria
✓. Written informed consent in accordance with study site guidelines.
✓. Female 18\~45 years of age when signing the ICF for Part A, and 18\~55 years of age when signing the ICF for Part B.
✓. Body mass index (BMI) ≤30 kg/m2.
✓. Pathological diagnosis of CIN Grade 2 or 3 as confirmed by central pathological reviewers within 12 weeks prior to administration of first study vaccination.
✓. The lesion of CIN Grade 2 or 3 is large enough for histopathologic biopsy at screening and during treatment.
✓. Has a satisfactory colposcopy at screening, i.e., the entire lesion as well as the entire squamocolumnar junction (type 1 or 2 transformation zone) is visualizable by colposcopy;
✓. Confirmed high-risk HPV infection with HPV16+ and / or HPV18+ by a commercially available high-risk DNA assay (e.g., Cobas® HPV test from Roche).
✓. Adequate hematologic, renal, and hepatic function are determined by the Investigator, based upon medical history, physical examination, and laboratory test results at screening:
Exclusion criteria
✕. Cervical adenocarcinoma in situ (AIS), or atypical endometrial or glandular cells, or evidence of invasive cervical carcinoma on cervical biopsy within 12 weeks prior to administration of first study vaccination.
✕. High-grade intraepithelial neoplasia or invasive carcinoma of vulva, vagina or anus.
What they're measuring
1
Part A: Safety and Tolerability of RG002 Injection, measured by the incidence of adverse events
Timeframe: Week 9
2
Part A: Maximum tolerated dose (MTD) and/or RP2D of RG002 Injection
Timeframe: MTD:Week 9; RP2D: Week 36
3
Part B: Primary efficacy of RG002 Injection, measured by the proportion of subjects with histopathological regression
. History of severe allergy to any vaccine or serious hypersensitivity reaction to a known ingredient (e.g., PEG) of RG002 injection judged by the investigator.
✕. Active infection with herpes simplex virus (HSV).
✕. Positive serological test at screening for HIV virus, active syphilis infection, or positive hepatitis B virus surface antigen (HbsAg) and the number of copies of hepatitis B virus (HBV) deoxyribonucleic acid (DNA) ≥ 500 IU/mL (or 2500 copies, or the lower limit of the positive detection value of the study site) at screening, or HbsAg (-), hepatitis B core antibody (HbcAb) (+) and the number of copies of HBV DNA ≥ 500 IU/mL (or 2500 copies, or the lower limit of the positive detection value of the study site) after treatment of HBV infection, or positive hepatitis C antibody (HCV-Ab) and hepatitis C virus (HCV) ribonucleic acid (RNA) ≥ ULN of the study site.
✕. Subjects with a concurrent condition of fatty liver disease at screening.
✕. Subjects with poorly controlled diabetes (fasting blood glucose ≥ 10mmol/L) after drug treatment at screening.
✕. History of serious cardiovascular and cerebrovascular diseases, including but not limited to serious cardiac rhythm or conduction abnormalities, such as ventricular arrhythmia requiring clinical intervention; repeated 12-lead ECG with QTcF interval ≥ 470 msec; acute coronary syndrome, congestive cardiac failure, aortic dissection, stroke or other Grade 3 or above cardiovascular and cerebrovascular events within 6 months before the first administration; New York Heart Association (NYHA) cardiac function classification ≥ Grade III or hypertension that cannot be clinically controlled (systolic blood pressure ≥ 150 mmHg, diastolic blood pressure ≥ 100 mmHg).