Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06273553 | A Study in Subjects With Human Papillomavirus 16 or 18 Associated Cervical Intraepithelial Neoplasia Grade 2 or 3 | PHASE1 | NOT YET_RECRUITING | 39 | — | — | Mar 1, 2024 | Dec 1, 2027 | Feb 22, 2024 | - | — |
Safety and Tolerability of RG002 Injection will be measured by the incidence of adverse events per CTCAE v5.0
The proportion of subjects with histopathological regression to either CIN1 or normal at Week 36
| Arm | Type | Description |
|---|---|---|
| RG002 Injection | EXPERIMENTAL | In Part A, subjects with histologically confirmed Cervical Intraepithelial Neoplasia Grade 2 or 3 (CIN2/3) associated with Human Papillomavirus (HPV) 16 or 18, will be allocated to three dose cohorts that are 25µg,75µg and 150µg. In Part B, subjects with histologically confirmed Cervical Intraepithelial Neoplasia Grade 2 or 3 (CIN2/3) associated with Human Papillomavirus (HPV) 16 or 18, will be allocated to 1 or 2 dose levels according to the results of Part A. All subjects will receive a total of three RG002 Injections, administered intramuscularly at assigned dose level, with a dosing frequency of every 2 weeks (D1, D15, and D29). |
| Name | Type | Description |
|---|---|---|
| RG002 injection | BIOLOGICAL | In Part A, there are three dose cohorts that are 25µg,75µg and 150µg. In Part B, there will 1 or 2 dose levels according to the results of Part A. All subjects will receive a total of three RG002 Injections, administered intramuscularly at assigned dose level, with a dosing frequency of every 2 weeks (D1, D15, and D29). |
Inclusion Criteria: 1. Written informed consent in accordance with study site guidelines. 2. 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. 3. Body mass index (BMI) ≤30 kg/m2. 4. Pathological diagnosis of CIN Grade 2 or 3 as conf...