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DAN-222 for Breast Cancer

Phase 1

Waitlist Available

Research Sponsored by Dantari, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 years

Awards & highlights

Study Summary

This trial is designed to study the safety and effectiveness of two different doses of DAN-222, either alone or in combination with niraparib, in women with HER2-negative breast cancer.

Eligible Conditions

Metastatic Breast Cancer

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Clearance rate

Incidence and nature of Dose Limiting Toxicities (DLTs)

Incidence, nature, and severity of adverse events graded according to NCI CTCAE v5.0

+5 more

Secondary outcome measures

Clinical benefit rate (CBR) per RECIST v1.1, defined as the proportion of patients having a BOR of SD ≥ 6 months, PR or CR as determined by Investigator review.

Disease control rate (DCR) per RECIST v1.1, defined as best overall response of complete response (CR), partial response (PR), or stable disease (SD) as determined by Investigator review.

Duration of response, defined as the time from first occurrence of a documented objective response until the time of disease progression, as determined by Investigator review with use of RECIST v1.1, or death from any cause during the study.

+2 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Dose Escalation (DAN-222)Experimental Treatment1 Intervention

The starting dose of DAN-222 will be administered IV every week (QW) to subjects in the first cohort.

Group II: Dose Escalation (DAN-222 + niraparib)Experimental Treatment2 Interventions

The starting dose of DAN-222 will be administered IV every week (QW), in combination with daily oral niraparib.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

DAN-222

2022

Completed Phase 1

~30

Niraparib

FDA approved

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Dantari, Inc.Lead Sponsor

Media Library

DAN-222 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05261269 — Phase 1

Breast Cancer Research Study Groups: Dose Escalation (DAN-222 + niraparib), Dose Escalation (DAN-222)

Breast Cancer Clinical Trial 2023: DAN-222 Highlights & Side Effects. Trial Name: NCT05261269 — Phase 1

DAN-222 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05261269 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals are being recruited to participate in this clinical examination?

"Affirmative. The information hosted on clinicaltrials.gov verifies that the experiment, which debuted on February 2nd 2022, is now enrolling patients. A total of 30 individuals must be recruited from 8 distinct locations."

Answered by AI

Has the FDA granted authorization for DAN-222?

"At Power, we rated DAN-222's safety a 1 due to the limited evidence present in phase 1 trials that evaluate both efficacy and safety."

Answered by AI

Is this medical experiment currently recruiting participants?

"According to clinicaltrials.gov, this experiment is currently recruiting members; the trial was first shared on February 2nd 2022 and most recently revised on October 17th 2022."

Answered by AI

Are there a multitude of sites conducting this clinical experiment in the urban area?

"UC San Diego Moores Cancer Center, H Lee Moffitt Cancer Center and Research Institute, Magee Women's Hospital in Pittsburgh are the three primary sites for this clinical trial with an additional 8 medical centres across the US."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2022. "A Dose-escalation Study of the Safety and Pharmacology of DAN-222 in Subjects With Metastatic Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05261269.