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

NCT05261269 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2023-12-13

No results posted yet for this study

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

DRUG

DAN-222

Administered IV every week to subjects

DRUG

Niraparib

Administered orally once daily

Sponsors & Collaborators

  • Dantari, Inc.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-02
Primary Completion
2023-09-13
Completion
2023-10-11
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05261269 on ClinicalTrials.gov