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.
- Metastatic Breast Cancer
Treatment Effectiveness
Effectiveness Progress
Study Objectives
8 Primary · 5 Secondary · Reporting Duration: 3 years
Trial Safety
Safety Progress
Side Effects for
Trial Design
5 Treatment Groups
Dose Escalation (DAN-222)
1 of 5
Dose Escalation (DAN-222 + niraparib)
1 of 5
Dose Expansion (DAN-222)
1 of 5
Dose Expansion (DAN-222 + niraparib, HRD-positive)
1 of 5
Dose Expansion (DAN-222 + niraparib, HRD-negative)
1 of 5
Experimental Treatment
30 Total Participants · 5 Treatment Groups
Primary Treatment: DAN-222 · No Placebo Group · Phase 1
Trial Logistics
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age 18+ · Female Participants · 11 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:Frequently Asked Questions
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." - Anonymous Online Contributor
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." - Anonymous Online Contributor
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." - Anonymous Online Contributor
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." - Anonymous Online Contributor