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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 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. The trial reports 20 study locations across 12 states.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05150691
The ClinicalTrials.gov registry entry for NCT05150691 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 796 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is DualityBio, which has 10 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 12 distinct geographic areas - top geographies include 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.
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