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RECRUITING Phase 1

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

NCT05914116 · View on ClinicalTrials.gov ↗

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

40 total trials

Interested in This Trial?

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05914116

The ClinicalTrials.gov registry entry for NCT05914116 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 862 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is DualityBio, which has 40 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05914116 reports 20 study locations spanning 10 distinct geographic areas — top geographies include Florida, California, Ohio. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05914116?

This trial is sponsored by DualityBio, which has 40 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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