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NCT05914116 · ClinicalTrials.gov registry record · Phase 1
A Phase 1/2a Study of DB-1311/BNT324 in Advanced/Metastatic Solid Tumors
A Phase 1 study of Advanced Solid Tumors, sponsored by DualityBio.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 862
- Enrollment target
- 20
- Study locations
NCT05914116: Recruiting Phase 1 study of Advanced Solid Tumors, sponsored by DualityBio.
NCT05914116 is a Phase 1 study of Advanced Solid Tumors that is actively recruiting participants, run by DualityBio. The registered enrollment target is 862 participants, above the 193-participant average among 144 other Advanced Solid Tumors trials with a reported enrollment target (347% higher). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05914116, a Phase 1 study of Advanced Solid Tumors, is actively recruiting participants, sponsored by DualityBio.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 862 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a dose-escalation and dose-expansion Phase 1/2a trial to evaluate the safety and tolerability of DB-1311/BNT324 in subjects with advanced solid tumors.
Primary Outcome
Percentage of participants in Part 1 with DLTs
Conditions Studied
Interventions
- DRUG DB-1311
- DRUG Lopinavir and Ritonavir Tablets
- DRUG itraconazole
- DRUG Enzalutamide
- DRUG Abiraterone
Study Locations (20)
Florida
- Research Site 118 - Celebration
- Research Site 127 - Margate
- Research Site 137 - Orlando
- Research Site 101 - Plantation
- Research Site 109 - Tamarac
California
- Research Site 125 - Los Angeles
- Research Site 133 - Los Angeles
- Research Site 103 - Los Angeles
- Research Site 128 - Santa Monica
Ohio
- Research Site 138 - Canton
- Research Site 113 - Cincinnati
- Research Site 131 - Dayton
Georgia
- Research Site 114 - Atlanta
- Research Site 139 - Atlanta
Arizona
- Research Site 111 - Tucson
Kentucky
- Research Site 115 - Louisville
Michigan
- Research Site 129 - Detroit
Minnesota
- Research Site 121 - Saint Paul
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 862 participants |
| Start Date | 2023-08-17 |
| Est. Completion | 2028-05 |
| Phase | Phase 1 |
What NCT05914116 shows while recruiting
NCT05914116 is an interventional study that assigns participants to a tested intervention. The registered 862 participants enrollment target is mid-sized for trials with a published cap, above the 193-participant average among 144 other Advanced Solid Tumors trials with a reported enrollment target (347% higher).
The record links to 1 condition, with Advanced Solid Tumors appearing as the primary indexed condition, and to 5 interventions - of which DB-1311 is the first listed.
NCT05914116 names 20 study sites across 10 states, led by Florida, California, Ohio.
Frequently Asked Questions
What is clinical trial NCT05914116 about?
NCT05914116 is a clinical study titled "A Phase 1/2a Study of DB-1311/BNT324 in Advanced/Metastatic Solid Tumors". This is a dose-escalation and dose-expansion Phase 1/2a trial to evaluate the safety and tolerability of DB-1311/BNT324 in subjects with advanced solid tumors.
What is the current status of trial NCT05914116?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 862 participants. The study started on 2023-08-17. Estimated completion is 2028-05.
What conditions does trial NCT05914116 study?
This clinical trial studies the following conditions: Advanced Solid Tumors.
What interventions are being tested in trial NCT05914116?
The interventions under investigation include: DB-1311 (DRUG), Lopinavir and Ritonavir Tablets (DRUG), itraconazole (DRUG), Enzalutamide (DRUG), Abiraterone (DRUG).
Who is sponsoring clinical trial NCT05914116?
This trial is sponsored by DualityBio, which has 10 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05914116 being conducted?
This trial has 20 study locations across Arizona, California, Florida, Georgia, Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Advanced Solid Tumors
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 NCT05914116's enrollment target sits among peer trials
862 3rd of 144 higher than 142 of 144 other Advanced Solid Tumors trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Advanced Solid Tumors 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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