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

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. According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

Percentage of participants in Part 1 with DLTs

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
DualityBio

10 total trials

What NCT05438329 shows while recruiting

NCT05438329 is an interventional study that assigns participants to a tested intervention. Its 1,123 participants enrollment target places it among the larger protocols in the corpus, above the 187-participant average among 189 other Advanced Solid Tumor trials with a reported enrollment target (501% higher).

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 names 20 study sites across 15 states, led by 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.

Learn More About Clinical Trials

Similar trials for Advanced Solid Tumor

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT05438329's enrollment target sits among peer trials

1,123 2nd of 189 the highest of 189 other Advanced Solid Tumor trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Advanced Solid Tumor trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.

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More recruiting context for NCT05438329

Source: ClinicalTrials.gov NCT05438329, the US trial registry maintained by the National Library of Medicine. NCT05438329 (large enrollment · wide site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.