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Recruiting Phase 1Phase 2 Interventional

A Phase 1/2a Study of DB-1311/BNT324 in Advanced/Metastatic Solid Tumors

ClinicalTrials.gov ID: NCT05914116

Public ClinicalTrials.gov record NCT05914116. 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.

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ClinicalTrials.gov public records Last synced May 4, 2026, 11:08 PM EDT

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-1311 in Subjects With Advanced/Metastatic Solid Tumors

Study identification

NCT ID
NCT05914116
Recruitment status
Recruiting
Study type
Interventional
Phase
Phase 1, Phase 2
Lead sponsor
DualityBio Inc.
Industry
Enrollment
862 participants

Conditions and interventions

Interventions

  • Abiraterone Drug
  • DB-1311 Drug
  • Enzalutamide Drug
  • Lopinavir and Ritonavir Tablets Drug
  • itraconazole Drug

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
Aug 16, 2023
Primary completion
Nov 30, 2027
Completion
Apr 30, 2028
Last update posted
Nov 20, 2025

2023 – 2028

United States locations

U.S. sites
28
U.S. states
15
U.S. cities
24
Facility City State ZIP Site status
Research Site 111 Tucson Arizona 85711 Recruiting
Research Site 125 Los Angeles California 90033 Recruiting
Research Site 133 Los Angeles California 90067 Recruiting
Research Site 103 Los Angeles California 90095 Recruiting
Research Site 128 Santa Monica California 90403 Recruiting
Research Site 118 Celebration Florida 34747 Recruiting
Research Site 127 Margate Florida 33063 Recruiting
Research Site 137 Orlando Florida 32827 Recruiting
Research Site 101 Plantation Florida 33322 Recruiting
Research Site 109 Tamarac Florida 33321 Recruiting
Research Site 114 Atlanta Georgia 30318 Recruiting
Research Site 139 Atlanta Georgia 30322 Recruiting
Research Site 115 Louisville Kentucky 40202 Recruiting
Research Site 129 Detroit Michigan 48201 Recruiting
Research Site 121 Saint Paul Minnesota 55101 Recruiting
Research Site 110 Las Vegas Nevada 89169 Recruiting
Research Site 107 New York New York 10032 Recruiting
Research Site 138 Canton Ohio 44718 Recruiting
Research Site 113 Cincinnati Ohio 45267 Recruiting
Research Site 131 Dayton Ohio 45409 Recruiting
Research Site 123 Charleston South Carolina 29425 Recruiting
Research Site 108 Greenville South Carolina 29607 Recruiting
Research Site 136 Nashville Tennessee 37203 Recruiting
Research Site 135 Austin Texas 78731 Recruiting
Research Site 120 Dallas Texas 75390 Recruiting
Research Site 102 Fairfax Virginia 22031 Recruiting
Research Site 112 Fairfax Virginia 22031 Recruiting
Research Site 105 Spokane Washington 99208 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 79 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT05914116, 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 Nov 20, 2025 · Synced May 4, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT05914116 live on ClinicalTrials.gov.

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