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NCT05150691 · ClinicalTrials.gov registry record · Phase 1
A Phase 1/2a Study of DB-1303/BNT323 in Advanced/Metastatic Solid Tumors
A Phase 1 study of HER2-positive Advanced Solid Tumor, sponsored by DualityBio.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 796
- Enrollment target
- 20
- Study locations
NCT05150691: Recruiting Phase 1 study of HER2-positive Advanced Solid Tumor, sponsored by DualityBio.
NCT05150691 is a Phase 1 study of HER2-positive Advanced Solid Tumor that is actively recruiting participants, run by DualityBio. The registered enrollment target is 796 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (1227% higher). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05150691, a Phase 1 study of HER2-positive Advanced Solid Tumor, is actively recruiting participants, sponsored by DualityBio.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 796 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-1303/BNT323 in subjects with advanced solid tumors that express HER2.
Primary Outcome
Percentage of participants in Part 1 with DLTs
Conditions Studied
Interventions
- DRUG Itraconazole
- DRUG Ritonavir
- BIOLOGICAL DB-1303/BNT323
- DRUG Pertuzumab Injection
Study Locations (20)
Florida
- Advanced Research LLC - Coral Springs
- The Oncology Institute of Hope and Innovation - Lakeland
- D&H Cancer Research Center LLC - Margate
- HCA Mercy Hospital - Miami
- BRCR Medical Center Inc. - Plantation
- BRCR Medical Center Inc. - Tamarac
California
- Helios Clinical Research - Cerritos
- California Research Institute - Los Angeles
- Sharp Memorial Hospital - San Diego
Massachusetts
- Massachusetts General Hospital - Boston
- Beth Israel Deaconess Medical Center - Boston
District of Columbia
- Washington Cancer Institute at MedStar Washington Hospital Center - Washington D.C.
Georgia
- Southeastern Regional Medical Center, LLC - Newnan
Hawaii
- Kapi'olani Medical Center for Women and Children - Honolulu
Illinois
- University of Chicago - Chicago
Louisiana
- Women's Cancer Care - Covington
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 796 participants |
| Start Date | 2022-01-31 |
| Est. Completion | 2027-10 |
| Phase | Phase 1 |
What NCT05150691 shows while recruiting
NCT05150691 is an interventional study that assigns participants to a tested intervention. The registered 796 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (1227% higher).
The record links to 1 condition, with HER2-positive Advanced Solid Tumor appearing as the primary indexed condition, and to 4 interventions - of which Itraconazole is the first listed.
NCT05150691 names 20 study sites across 12 states, led by Florida, California, Massachusetts.
Frequently Asked Questions
What is clinical trial NCT05150691 about?
NCT05150691 is a clinical study titled "A Phase 1/2a Study of DB-1303/BNT323 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-1303/BNT323 in subjects with advanced solid tumors that express HER2.
What is the current status of trial NCT05150691?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 796 participants. The study started on 2022-01-31. Estimated completion is 2027-10.
What conditions does trial NCT05150691 study?
This clinical trial studies the following conditions: HER2-positive Advanced Solid Tumor.
What interventions are being tested in trial NCT05150691?
The interventions under investigation include: Itraconazole (DRUG), Ritonavir (DRUG), DB-1303/BNT323 (BIOLOGICAL), Pertuzumab Injection (DRUG).
Who is sponsoring clinical trial NCT05150691?
This trial is sponsored by DualityBio, which has 10 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05150691 being conducted?
This trial has 20 study locations across California, District of Columbia, Florida, Georgia, Hawaii. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05150691's enrollment target sits among peer trials
796 12th of 2000 higher than 1,989 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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