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NCT05438329 · ClinicalTrials.gov registry record · Phase 1

First-in-human Study of DB-1305/BNT325 for Advanced/Metastatic Solid Tumors

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

Recruiting
Registry status
Phase 1
Development phase
1,123
Enrollment target
20
Study locations

NCT05438329 is a Phase 1 study of Advanced Solid Tumor that is actively recruiting participants, run by DualityBio. The registered enrollment target is 1,123 participants, above the 187-participant average among 189 other Advanced Solid Tumor trials with a reported enrollment target (501% higher). The trial reports 20 study locations across 15 states.

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The verdict

NCT05438329, a Phase 1 study of Advanced Solid Tumor, is actively recruiting participants, sponsored by DualityBio.

RECRUITING
Registry status
Phase 1
Development phase
1,123 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-1305/BNT325 in subjects with advanced solid tumors.

Conditions Studied

Advanced Solid Tumor

Interventions

  • DRUG DB-1305/BNT325
  • COMBINATION_PRODUCT Pembrolizumab
  • DRUG BNT327

Study Locations (20)

Florida

  • D&H Cancer Research Center Llc - Margate
  • Site 109 - Plantation
  • BRCR Medical Center Inc. - Tamarac

California

  • Site 103 - Cerritos
  • Site 108 - Los Angeles

Texas

  • Site 110 - Arlington
  • Site 104 - Houston

Anhui

  • Site 211 - Bengbu
  • Site 217 - Hefei

Michigan

  • Site 106 - Detroit

New York

  • Site 102 - New York

Ohio

  • Site 101 - Canton

Tennessee

  • Site 105 - Nashville

Trial Details

FieldValue
Enrollment Target 1,123 participants
Start Date 2022-07-19
Est. Completion 2025-06-30
Phase Phase 1

Sponsor

DualityBio

10 total trials

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What the Registry Record Tells You About NCT05438329

The ClinicalTrials.gov registry entry for NCT05438329 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 1,123 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 187-participant average among 189 other Advanced Solid Tumor trials with a reported enrollment target (501% 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 Tumor appearing as the primary indexed condition, and to 3 interventions - of which DB-1305/BNT325 is the first listed.

NCT05438329 reports 20 study locations spanning 15 distinct geographic areas - top geographies include Florida, California, Texas.

Frequently Asked Questions

What is clinical trial NCT05438329 about?

NCT05438329 is a clinical study titled "First-in-human Study of DB-1305/BNT325 for Advanced/Metastatic Solid Tumors". 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.

What is the current status of trial NCT05438329?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 1,123 participants. The study started on 2022-07-19. Estimated completion is 2025-06-30.

What conditions does trial NCT05438329 study?

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

What interventions are being tested in trial NCT05438329?

The interventions under investigation include: DB-1305/BNT325 (DRUG), Pembrolizumab (COMBINATION_PRODUCT), BNT327 (DRUG).

Who is sponsoring clinical trial NCT05438329?

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

Where is trial NCT05438329 being conducted?

This trial has 20 study locations across California, Florida, Michigan, New York, Ohio. 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.