NCT05261269

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Dantari, Inc. · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• HER2-negative Metastatic Breast Cancer

Interventions

Type	Name	Description
DRUG	DAN-222	Administered IV every week to subjects
DRUG	Niraparib	Administered orally once daily

Timeline

• Start date: 2022-02-02
• Primary completion: 2023-09-13
• Completion: 2023-10-11
• First posted: 2022-03-02
• Last updated: 2023-12-13

Locations

9 sites across 1 country: United States

Regulatory

• FDA-regulated drug study