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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is a dose-escalation and dose-expansion Phase 1/2a trial to evaluate the safety and tolerability of DB-1305/BNT325 in subjects with advanced solid tumors.
Study identification
- NCT ID
- NCT05438329
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 1,123 participants
Conditions and interventions
Conditions
Interventions
- DB-1305/BNT325 Drug
- Pembrolizumab Combination Product
- BNT327 Drug
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 19, 2022 (Actual)
- Primary completion
- Aug 13, 2027 (Estimated)
- Completion
- Sep 10, 2027 (Estimated)
- Last update posted
- May 12, 2026
2022 – 2027
United States locations
- U.S. sites
- 42
- U.S. states
- 18
- U.S. cities
- 37
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Site 139 | Bullhead City | Arizona | 86442 | — |
| Site 103 | Cerritos | California | 90703 | — |
| Site 136 | La Jolla | California | 92093 | — |
| Site 127 | Los Angeles | California | 90027 | — |
| Site 133 | Los Angeles | California | 90067 | — |
| Site 108 | Los Angeles | California | 90404 | — |
| Site 131 | Washington D.C. | District of Columbia | 20007 | — |
| Site 122 | Coral Springs | Florida | 33065 | — |
| Site 142 | Hialeah | Florida | 33013 | — |
| Site 114 | Margate | Florida | 33063 | — |
| Site 120 | Miami | Florida | 33133 | — |
| Site 126 | Ocala | Florida | 34474 | — |
| Site 140 | Orange City | Florida | 32763 | — |
| Site 109 | Plantation | Florida | 33322 | — |
| Site 141 | St. Petersburg | Florida | 33709 | — |
| Site 117 | Tamarac | Florida | 33321 | — |
| Site 111 | Honolulu | Hawaii | 96813 | — |
| Site 134 | Chicago | Illinois | 60611 | — |
| Site 124 | Dearborn | Michigan | 48126 | — |
| Site 106 | Detroit | Michigan | 48201 | — |
| Site 125 | Royal Oak | Michigan | 48073 | — |
| Site 129 | Las Vegas | Nevada | 89106 | — |
| Site 160 | Mineola | New York | 11501 | — |
| Site 116 | New York | New York | 10016 | — |
| Site 102 | New York | New York | 10065 | — |
| Site 130 | Westbury | New York | 11590 | — |
| Site 121 | Wilson | North Carolina | 27895 | — |
| Site 101 | Canton | Ohio | 44718 | — |
| Site 132 | Cincinnati | Ohio | 45219 | — |
| Site 118 | Oklahoma City | Oklahoma | 73104 | — |
| Site 123 | Philadelphia | Pennsylvania | 19107 | — |
| Site 112 | Pittsburgh | Pennsylvania | 15224 | — |
| Site 105 | Nashville | Tennessee | 37203 | — |
| Site 110 | Arlington | Texas | 76017 | — |
| Site 104 | Houston | Texas | 77030 | — |
| Site 115 | Houston | Texas | 77074 | — |
| Site 119 | Tyler | Texas | 75701 | — |
| Site 107 | Fairfax | Virginia | 22031 | — |
| Site 135 | Falls Church | Virginia | 19107 | — |
| Site 128 | Tacoma | Washington | 98405 | — |
| Site 138 | Tacoma | Washington | 98405 | — |
| Site 137 | Sheboygan | Wisconsin | 53081 | — |
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 51 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 May 12, 2026 · Synced Oct 19, 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 public registry record, listed eligibility criteria, and available contact information for NCT05438329 live on ClinicalTrials.gov.