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Completed Phase 1 Interventional

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

ClinicalTrials.gov ID: NCT05261269

Public ClinicalTrials.gov record NCT05261269. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Nov 9, 2026, 3:58 PM EST

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Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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

Study identification

NCT ID
NCT05261269
Recruitment status
Completed
Study type
Interventional
Phase
Phase 1
Lead sponsor
Dantari, Inc.
Industry
Enrollment
30 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
Female
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Feb 2, 2022 (Actual)
Primary completion
Sep 13, 2023 (Actual)
Completion
Oct 11, 2023 (Actual)
Last update posted
Dec 13, 2023

2022 – 2023

United States locations

U.S. sites
9
U.S. states
8
U.S. cities
9
Facility City State ZIP Site status
UC San Diego Moores Cancer Center La Jolla California 92093 —
UCLA - Parkside Cancer Center Santa Monica California 90404 —
H Lee Moffitt Cancer Center and Research Institute Tampa Florida 33612 —
University of Michigan Ann Arbor Michigan 48109 —
Saint Luke's Cancer Institute Jackson Missouri 64111 —
Icahn School of Medicine at Mount Sinai New York New York 10029 —
The University of Oklahoma Health Sciences Center Oklahoma City Oklahoma 73104 —
Magee Women's Hospital Pittsburgh Pennsylvania 15232 —
Sarah Cannon Research Institute/Tennessee Oncology Nashville Tennessee 37203 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT05261269, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Dec 13, 2023 · Synced Nov 9, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT05261269 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →