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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04398108 | A Study to Evaluate the Pharmacokinetics of Margetuximab in Chinese Patients With HER2+ MBC | PHASE1 | COMPLETED | 16 | — | — | Aug 25, 2020 | Apr 27, 2021 | Jun 14, 2021 | 3 | China |
| Arm | Type | Description |
|---|---|---|
| Margetuximab & Chosen Chemotherapy | EXPERIMENTAL | The dosage and administering of margetuximab is 15 mg/kg IV every 21 days. Investigators need to choose one of the 3 chemotherapies based on patient conditions. |
| Name | Type | Description |
|---|---|---|
| Margetuximab Margetuximab-IV | DRUG | Drug: Chosen Chemotherapy (Capecitabine) -Oral Capecitabine tablet Drug: Chosen Chemotherapy (Vinorelbine) Vinorelbine -IV Drug: Chosen Chemotherapy (Gemcitabine) Gemcitabine -IV |
Inclusion Criteria: * Written informed consent obtained prior to performing any protocol-related procedures * Male or female, age ≥ 18 years old at the time of screening. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Subject has histologically confirmed HER2 positive me...