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NCT05914116 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Advanced Solid Tumors, sponsored by DualityBio.

Recruiting
Registry status
Phase 1
Development phase
862
Enrollment target
20
Study locations

NCT05914116 is a Phase 1 study of Advanced Solid Tumors that is actively recruiting participants, run by DualityBio. The registered enrollment target is 862 participants, above the 193-participant average among 144 other Advanced Solid Tumors trials with a reported enrollment target (347% higher). The trial reports 20 study locations across 10 states.

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The verdict

NCT05914116, a Phase 1 study of Advanced Solid Tumors, is actively recruiting participants, sponsored by DualityBio.

RECRUITING
Registry status
Phase 1
Development phase
862 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-1311/BNT324 in subjects with advanced solid tumors.

Conditions Studied

Interventions

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

Study Locations (20)

Florida

  • Research Site 118 - Celebration
  • Research Site 127 - Margate
  • Research Site 137 - Orlando
  • Research Site 101 - Plantation
  • Research Site 109 - Tamarac

California

  • Research Site 125 - Los Angeles
  • Research Site 133 - Los Angeles
  • Research Site 103 - Los Angeles
  • Research Site 128 - Santa Monica

Ohio

  • Research Site 138 - Canton
  • Research Site 113 - Cincinnati
  • Research Site 131 - Dayton

Georgia

  • Research Site 114 - Atlanta
  • Research Site 139 - Atlanta

Arizona

  • Research Site 111 - Tucson

Kentucky

  • Research Site 115 - Louisville

Michigan

  • Research Site 129 - Detroit

Minnesota

  • Research Site 121 - Saint Paul

Trial Details

FieldValue
Enrollment Target 862 participants
Start Date 2023-08-17
Est. Completion 2028-05
Phase Phase 1

Sponsor

DualityBio

10 total trials

What the Registry Record Tells You About NCT05914116

The ClinicalTrials.gov registry entry for NCT05914116 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 862 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 193-participant average among 144 other Advanced Solid Tumors trials with a reported enrollment target (347% higher). The listed sponsor is DualityBio, which has 10 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Advanced Solid Tumors appearing as the primary indexed condition, and to 5 interventions - of which DB-1311 is the first listed.

NCT05914116 reports 20 study locations spanning 10 distinct geographic areas - top geographies include Florida, California, Ohio.

Frequently Asked Questions

What is clinical trial NCT05914116 about?

NCT05914116 is a clinical study titled "A Phase 1/2a Study of DB-1311/BNT324 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-1311/BNT324 in subjects with advanced solid tumors.

What is the current status of trial NCT05914116?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 862 participants. The study started on 2023-08-17. Estimated completion is 2028-05.

What conditions does trial NCT05914116 study?

This clinical trial studies the following conditions: Advanced Solid Tumors.

What interventions are being tested in trial NCT05914116?

The interventions under investigation include: DB-1311 (DRUG), Lopinavir and Ritonavir Tablets (DRUG), itraconazole (DRUG), Enzalutamide (DRUG), Abiraterone (DRUG).

Who is sponsoring clinical trial NCT05914116?

This trial is sponsored by DualityBio, which has 10 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05914116 being conducted?

This trial has 20 study locations across Arizona, California, Florida, Georgia, Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.