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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05275777 | A Phase Ib Safety lead-in, Followed by Phase II Trial of ADG106 in Combination With Neoadjuvant Chemotherapy in HER2 Negative Breast Cancer | PHASE1 | ACTIVE NOT_RECRUITING | 66 | — | — | May 19, 2022 | Feb 1, 2030 | Jul 25, 2025 | 1 | Singapore |
Toxicities will be graded using the Common Terminology Criteria for Adverse Events (CTCAE) toxicity grading version 5.0.
Biological changes on immunohistochemistry will be evaluated using paraffin-embedded tumor specimens.
| Arm | Type | Description |
|---|---|---|
| ADG106 combined with dose dense Doxorubicin and Cyclophosphamide (Phase Ib) | EXPERIMENTAL | Intravenous ADG106 + 2 weekly doxorubicin and cyclophosphamide |
| ADG106 combined with Paclitaxel (Phase Ib) | EXPERIMENTAL | Intravenous ADG106 + weekly paclitaxel |
| ADG106 combined with dose dense Doxorubicin and Cyclophosphamide follow by Paclitaxel (Phase II) | EXPERIMENTAL | Intravenous ADG106 combined with two weekly doxorubicin and cyclophosphamide followed intravenous ADG106 combined with weekly paclitaxel |
| Name | Type | Description |
|---|---|---|
| ADG106 | DRUG | Administered as an intravenous infusion over 60-90 minutes in the initial cycle and over 30 minutes in subsequent cycle if well tolerated. |
| Doxorubicin | DRUG | Administered as an intravenous infusion. |
| Cyclophosphamide | DRUG | Administered as an intravenous infusion. |
| Paclitaxel | DRUG | Administered as an intravenous infusion. |
Inclusion Criteria: Patients may be included in the study only if they meet all of the following criteria: 1. All patients must sign an informed consent in accordance with local institutional guidelines. 2. 18 years and above of age. 3. Estimated life expectancy of at least 12 weeks. 4. Has recove...