First-in-human Study of DB-1305/BNT325 for Advanced/Metastatic Solid Tumors
Public ClinicalTrials.gov record NCT05438329. 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-1305 in Subjects With Advanced/Metastatic Solid Tumors
Study identification
- NCT ID
- NCT05438329
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Lead sponsor
- DualityBio Inc.
- Industry
- Enrollment
- 1,123 participants
Conditions and interventions
Conditions
Interventions
- BNT327 Drug
- DB-1305/BNT325 Drug
- Pembrolizumab Combination Product
Drug · Combination Product
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
- Jul 18, 2022
- Primary completion
- Jun 29, 2025
- Completion
- Jun 29, 2025
- Last update posted
- Feb 26, 2025
2022 – 2025
United States locations
- U.S. sites
- 12
- U.S. states
- 8
- U.S. cities
- 12
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Site 103 | Cerritos | California | 90703 | Recruiting |
| Site 108 | Los Angeles | California | 90095 | Recruiting |
| D&H Cancer Research Center Llc | Margate | Florida | 33063 | Recruiting |
| Site 109 | Plantation | Florida | 33322 | Recruiting |
| BRCR Medical Center Inc. | Tamarac | Florida | 33321 | Recruiting |
| Site 106 | Detroit | Michigan | 48201 | Recruiting |
| Site 102 | New York | New York | 10065 | Recruiting |
| Site 101 | Canton | Ohio | 44718 | Recruiting |
| Site 105 | Nashville | Tennessee | 37203 | Recruiting |
| Site 110 | Arlington | Texas | 76017 | Recruiting |
| Site 104 | Houston | Texas | 77030 | Recruiting |
| Site 107 | Fairfax | Virginia | 22031 | 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 18 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05438329, 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 Feb 26, 2025 · Synced May 7, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05438329 live on ClinicalTrials.gov.