A Dose-escalation Study of the Safety and Pharmacology of DAN-222 in Subjects With Metastatic Breast Cancer
Status:
Recruiting
Trial end date:
2023-06-30
Target enrollment:
Participant gender:
Summary
This is an open-label, multicenter, dose-escalation study designed to assess the safety,
tolerability, and PK of IV administered DAN-222 followed by a dose-escalation of DAN-222 in
combination with niraparib. There are two stages within this study:
Stage 1:
- Part A is dose escalation of single agent DAN-222
- Part B is dose escalation of DAN-222 in combination with niraparib
Stage 2:
Expansion of three separate HER2-negative mBC cohorts: one group for single agent DAN-222 in
subjects with HRD-positive or HRD-negative tumors and 1 cohort each for DAN-222 combined with
niraparib of HRD-positive tumors or HRD-negative tumors.