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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05519059 | Pelareorep and Paclitaxel Injection in Chinese Patients With Advanced or Metastatic Breast Cancer | PHASE1 | COMPLETED | 15 | — | — | Oct 11, 2021 | May 30, 2023 | Nov 22, 2023 | 1 | China |
DLTs are defined as study drug-related toxicities graded using Common Terminology Criteria for Adverse events of the National Cancer Institute (NCI CTCAE) V5.0 occurring during DLT period (the first 4 weeks of AN0025 administration in combination with dCRT)
| Arm | Type | Description |
|---|---|---|
| Patients With Advanced or Metastatic Breast Cancer | EXPERIMENTAL | Patients will receive Pelareorep with Paclitaxel for 8 cycles (28 days/cycle). |
| Name | Type | Description |
|---|---|---|
| Pelareorep | DRUG | Pelareorep at 1.5×10\^10 TCID50, 3×10\^10 TCID50, 4.5×10\^10 TCID50 on Day 1/2/8/9/15/16 with Paclitaxel at 80 mg/m\^2 on Day 1/8/15 per cycle |
Inclusion Criteria: Subjects are eligible to be included in the study only if all of the following criteria apply: 1. Voluntarily participating in this trial and having signed the Informed Consent Form (ICF). 2. Women aged ≥18 and ≤70 years (at the time of signing ICF). 3. Pathohistologically or c...