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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04596150 | Study to Evaluate the Safety and Antitumor Activity of CX-2009 Monotherapy and in Combination With CX-072 in Advanced Breast Cancer | PHASE2 | COMPLETED | 125 | — | — | Dec 29, 2020 | Jun 2, 2023 | Jan 23, 2024 | 42 | United States, South Korea +1 |
ORR is the proportion of patients in the efficacy-evaluable population with a best response of Complete Response (CR) or Partial Response (PR) based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by Central Radiology Review (CRR)
| Arm | Type | Description |
|---|---|---|
| ARM A - CX-2009 Monotherapy, HR-positive/HER2-negative | EXPERIMENTAL | CX-2009 Monotherapy in advanced, metastatic Hormone Receptor (HR)-positive / Human Epidermal growth factor Receptor 2 (HER2)-negative breast cancer |
| ARM B - CX-2009 Monotherapy, TNBC | EXPERIMENTAL | CX-2009 Monotherapy in advanced, metastatic Triple-Negative Breast Cancer (TNBC) |
| ARM C - CX-2009 Combination therapy, TNBC | EXPERIMENTAL | CX-2009 and CX-072 Combination therapy in advanced, metastatic TNBC |
| Name | Type | Description |
|---|---|---|
| CX-2009 | DRUG | Intravenous administration of the CX-2009 of 6 mg/kg administered every 3 weeks (Q3W) |
| CX-072 | DRUG | Intravenous administration of the CX-072 of 1200 mg administered every 3 weeks (Q3W) |
INCLUSION CRITERIA: * Arm A: inoperable, locally advanced or metastatic HR-positive/HER2-negative breast cancer. Patients must have received 0 to 2 prior cytotoxic chemotherapy in the inoperable, locally advanced, or metastatic setting * Arm B and Arm C: inoperable, locally advanced or metastatic T...