A Phase 1/2a Study of DB-1303/BNT323 in Advanced/Metastatic Solid Tumors
Public ClinicalTrials.gov record NCT05150691. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 1/2a, Multicenter, Open-Label, First in Human Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of DB-1303/BNT323 in Patients With Advanced/Metastatic Solid Tumors
Study identification
- NCT ID
- NCT05150691
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Lead sponsor
- DualityBio Inc.
- Industry
- Enrollment
- 796 participants
Conditions and interventions
Conditions
Interventions
- DB-1303/BNT323 Biological
- Itraconazole Drug
- Pertuzumab Injection Drug
- Ritonavir Drug
Biological · Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 30, 2022
- Primary completion
- Mar 31, 2026
- Completion
- Sep 30, 2027
- Last update posted
- Jan 27, 2026
2022 – 2027
United States locations
- U.S. sites
- 35
- U.S. states
- 21
- U.S. cities
- 32
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Helios Clinical Research | Cerritos | California | 90703 | Active, not recruiting |
| California Research Institute | Los Angeles | California | 90027 | Active, not recruiting |
| Sharp Memorial Hospital | San Diego | California | 92123 | Active, not recruiting |
| Washington Cancer Institute at MedStar Washington Hospital Center | Washington D.C. | District of Columbia | 20010 | Active, not recruiting |
| Advanced Research LLC | Coral Springs | Florida | 33065 | Active, not recruiting |
| The Oncology Institute of Hope and Innovation | Lakeland | Florida | 33812 | Active, not recruiting |
| D&H Cancer Research Center LLC | Margate | Florida | 33063 | Active, not recruiting |
| HCA Mercy Hospital | Miami | Florida | 33133 | Withdrawn |
| BRCR Medical Center Inc. | Plantation | Florida | 33322 | Active, not recruiting |
| BRCR Medical Center Inc. | Tamarac | Florida | 33321 | Active, not recruiting |
| Southeastern Regional Medical Center, LLC | Newnan | Georgia | 30265 | Active, not recruiting |
| Kapi'olani Medical Center for Women and Children | Honolulu | Hawaii | 96826 | Active, not recruiting |
| University of Chicago | Chicago | Illinois | 60637 | Active, not recruiting |
| Women's Cancer Care | Covington | Louisiana | 70433 | Withdrawn |
| Holy Cross Hospital | Silver Spring | Maryland | 20910 | Withdrawn |
| Massachusetts General Hospital | Boston | Massachusetts | 02214 | Active, not recruiting |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | Active, not recruiting |
| Profound Research LLC/Michigan Hematology & Oncology Consultants | Dearborn | Michigan | 48126 | Withdrawn |
| David C. Pratt Cancer Center | St Louis | Missouri | 63141 | Active, not recruiting |
| Women's Cancer Center of Nevada | Las Vegas | Nevada | 89106 | Withdrawn |
| Northwell Health | Lake Success | New York | 11042 | Withdrawn |
| Laura & Isaac Perlmutter Cancer Center at NYC Langone Health | New York | New York | 10016 | Active, not recruiting |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | Active, not recruiting |
| North Shore Hematology Oncology Associate P.C. DBA New York Cancer and Blood Specialists | Shirley | New York | 11967 | Active, not recruiting |
| Regional Medical Oncology Center | Wilson | North Carolina | 27893 | Withdrawn |
| Gabrail Cancer Center | Canton | Ohio | 44718 | Active, not recruiting |
| University of Oklahoma | Oklahoma City | Oklahoma | 73104 | Active, not recruiting |
| Rittenhouse Hematology Oncology | Philadelphia | Pennsylvania | 19107 | Withdrawn |
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | Active, not recruiting |
| AHN West Penn Hospital | Pittsburgh | Pennsylvania | 15224 | Active, not recruiting |
| Tennessee Oncology | Nashville | Tennessee | 37203 | Active, not recruiting |
| Clinical Trial Network | Houston | Texas | 77074 | Withdrawn |
| Oncology and Hematology of South Texas, PA | Laredo | Texas | 78041 | Active, not recruiting |
| NEXT Virginia | Fairfax | Virginia | 22031 | Active, not recruiting |
| Swedish Cancer Institute | Seattle | Washington | 98104 | Active, not recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 67 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05150691, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jan 27, 2026 · Synced May 7, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05150691 live on ClinicalTrials.gov.