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NCT06460298 · ClinicalTrials.gov registry record · Phase 1
ProAgio in Combination With Gemcitabine in Patients With Metastatic Triple Negative Breast Cancer
A Phase 1 study of Triple Negative Breast Cancer, sponsored by ProDa BioTech.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 51
- Enrollment target
- 2
- Study locations
NCT06460298: Recruiting Phase 1 study of Triple Negative Breast Cancer, sponsored by ProDa BioTech.
NCT06460298 is a Phase 1 study of Triple Negative Breast Cancer that is actively recruiting participants, run by ProDa BioTech. The registered enrollment target is 51 participants, below the 246-participant average among 118 other Triple Negative Breast Cancer trials with a reported enrollment target (79% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06460298, a Phase 1 study of Triple Negative Breast Cancer, is actively recruiting participants, sponsored by ProDa BioTech.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 51 participants
- Enrollment target
- 2
- Study locations
Study Summary
This is a Phase I/II Trial Evaluating the Safety and Efficacy of ProAgio, an anti- αvβ3 Integrin Cytotoxin, in Combination with Gemcitabine in Patients with Metastatic Triple Negative Breast Cancer
Primary Outcome
To identify the maximum tolerated dose (MTD) of ProAgio in combination with gemcitabine in patients with metastatic TNBC who have been previously treated with at least two prior lines of therapy.
Conditions Studied
Interventions
- DRUG ProAgio Dose Levels (DL) 1,2,3,4
- DRUG ProAgio Dose Expansion
Study Locations (2)
Georgia
- Emory University Winship Cancer Institute - Atlanta
- Winship Cancer Institute of Emory University - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 51 participants |
| Start Date | 2024-08-20 |
| Est. Completion | 2026-10-01 |
| Phase | Phase 1 |
What NCT06460298 shows while recruiting
NCT06460298 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 51 participants, a relatively small participant target, below the 246-participant average among 118 other Triple Negative Breast Cancer trials with a reported enrollment target (79% lower).
The record links to 1 condition, with Triple Negative Breast Cancer appearing as the primary indexed condition, and to 2 interventions - of which ProAgio Dose Levels (DL) 1,2,3,4 is the first listed.
NCT06460298 reports a single indexed study location in Georgia.
Frequently Asked Questions
What is clinical trial NCT06460298 about?
NCT06460298 is a clinical study titled "ProAgio in Combination With Gemcitabine in Patients With Metastatic Triple Negative Breast Cancer". This is a Phase I/II Trial Evaluating the Safety and Efficacy of ProAgio, an anti- αvβ3 Integrin Cytotoxin, in Combination with Gemcitabine in Patients with Metastatic Triple Negative Breast Cancer
What is the current status of trial NCT06460298?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 51 participants. The study started on 2024-08-20. Estimated completion is 2026-10-01.
What conditions does trial NCT06460298 study?
This clinical trial studies the following conditions: Triple Negative Breast Cancer.
What interventions are being tested in trial NCT06460298?
The interventions under investigation include: ProAgio Dose Levels (DL) 1,2,3,4 (DRUG), ProAgio Dose Expansion (DRUG).
Who is sponsoring clinical trial NCT06460298?
This trial is sponsored by ProDa BioTech, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06460298 being conducted?
This trial has 2 study locations across Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Triple Negative Breast Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06460298's enrollment target sits among peer trials
51 73rd of 118 higher than 45 of 118 other Triple Negative Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Triple Negative Breast Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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