HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2–POSITIVE METASTATIC BREAST CANCER
Conditions
Brief summary
Objective response rate according to RECIST v1.1
Detailed description
Duration of response, disease control rate, progression free survival, overall survival, Incidence of treatment-emergent AEs and SAEs graded according to NCI CTCAE v5.0, Changes from baseline in vital signs, laboratory values, and ECGs, Cmin and Cmax values will be obtained throughout the study and compared to the PK data from the Phase 1 single agent BDC-1001 study utilizing a population approach, Incidence of anti-drug antibodies
Interventions
DRUGBDC-1001
DRUGPERTUZUMAB
Sponsors
Bolt Biotherapeutics Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate according to RECIST v1.1 | — |
Secondary
| Measure | Time frame |
|---|---|
| Duration of response, disease control rate, progression free survival, overall survival, Incidence of treatment-emergent AEs and SAEs graded according to NCI CTCAE v5.0, Changes from baseline in vital signs, laboratory values, and ECGs, Cmin and Cmax values will be obtained throughout the study and compared to the PK data from the Phase 1 single agent BDC-1001 study utilizing a population approach, Incidence of anti-drug antibodies | — |
Countries
France, Italy, Spain
Outcome results
None listed