drugset / Trial / NCT05261269

A Dose-escalation Study of the Safety and Pharmacology of DAN-222 in Subjects With Metastatic Breast Cancer

NCT05261269

Phase 1 Completed 30 enrolled Dantari, Inc.
Non-randomizedSequentialOpen-labelTreatment

Summary

This was 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: * Part A is dose escalation of single agent DAN-222 * Part B is dose escalation of DAN-222 in combination with niraparib

Timeline

Start
2022-02-02
Primary completion
2023-09-13
Completion
2023-10-11

Drugs

EvaluationDrugModalityDoseRoute
Subject DAN222 Unknown Intravenous
Background Niraparib Small molecule Oral