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DualityBio clinical trials

Source: ClinicalTrials.gov, U.S. National Library of Medicine and the EU Clinical Trials Information System (CTIS) — current trials in our USA, China, UK and EU (CTIS) registers with DualityBio as lead sponsor. Synced 26 Sep 2026
12Current trials
8Recruiting now
15Drugs in these trials
4Trial registers
Maintained by Sreepriya Prasannan
MSc Digital Transformation of Life Sciences (Innopharma Education / Griffith College); MSc & BSc Botany HSE Spark Ignite 2026 — Top 14 finalist
Compiled from ClinicalTrials.gov and CTIS registry records · Last verified · Editorial standards
At a glance

DualityBio is the lead sponsor of 12 current clinical trials in our USA, China, UK and EU (CTIS) registers. 8 are recruiting patients now. The most common phase is Phase 1/2. The drugs named most often in its trials are DB-1303/BNT323, Pumitamig and BNT324. The most-studied condition is Advanced Solid Tumor.

ClinicalTrials.gov trials by status

  • Recruiting873%
  • Active, closed327%

Trials by phase

  • Phase 1/2764%
  • Phase 3218%
  • Phase 219%
  • Phase 119%
01

Clinical trials sponsored by DualityBio

11 on ClinicalTrials.gov
StudyPhaseStatusStartRegisters
A Phase 1/2a Study of DB-1303/BNT323 in Advanced/Metastatic Solid Tumors
NCT05150691 · HER2-positive Advanced Solid Tumor
Phase 1/2 Recruiting 2022-01 USA, China
A Study of DB-1324 in Advanced/Metastatic Gastrointestinal Tumors
NCT07263594 · ClinicalTrials.gov ↗ · Gastrointestinal Cancer
Phase 1/2 Recruiting 2026-01 USA, China
First-in-human Study of DB-1419 for Advanced/Metastatic Solid Tumors
NCT06554795 · ClinicalTrials.gov ↗ · Solid Tumor, Adult
Phase 1/2 Recruiting 2024-09 USA, China
A Phase 1/2a Study of DB-1311/BNT324 in Advanced/Metastatic Solid Tumors
NCT05914116 · ClinicalTrials.gov ↗ · Advanced Solid Tumors
Phase 1/2 Recruiting 2023-08 USA, China
DB-1311 in Combination With BNT327 or DB-1305 in Advanced/Metastatic Solid Tumors
NCT06953089 · ClinicalTrials.gov ↗ · Solid Tumors
Phase 2 Recruiting 2025-07 USA, China
A Study of DB-1317 in Selected Advanced/Metastatic Solid Tumors
NCT07141706 · ClinicalTrials.gov ↗ · Advanced/Metastatic Solid Tumors
Phase 1 Recruiting 2025-09 USA, China
A Study of DB-1310 in Advanced/Metastatic Solid Tumors
NCT05785741 · ClinicalTrials.gov ↗ · Advanced Solid Tumor
Phase 1/2 Recruiting 2023-08 USA, China
A Phase 1/2a Study of DB-2304 in Healthy Adults and SLE/CLE Participants
NCT06625671 · ClinicalTrials.gov ↗ · Systemic Lupus Erythematosus (SLE) or Cutaneous Lupus Erythematosus
Phase 1/2 Recruiting 2024-10 USA
A Study of DB-1303/BNT323 vs Investigator's Choice Chemotherapy in HER2-Low, Hormone Receptor Positive Metastatic Breast Cancer (DYNASTY-Breast02)
NCT06018337 · Metastatic Breast Cancer
Phase 3 Active, closed 2024-01 UK, USA, China
First-in-human Study of DB-1305/BNT325 for Advanced/Metastatic Solid Tumors
NCT05438329 · Advanced Solid Tumor
Phase 1/2 Active, closed 2022-07 USA, China
A Study to Compare DB-1303/BNT323 Versus T-DM1 in Breast Cancer
NCT06265428 · ClinicalTrials.gov ↗ · HER2-positive Breast Cancer
Phase 3 Active, closed 2024-01 China

Registers list studies that are recruiting, about to open, active but closed to enrolment, or enrolling by invitation. The UK and USA registers cover industry-sponsored studies only. Titles and statuses are copied from the registry as published.

02

DualityBio in the EU trials register (CTIS)

1 trial

Authorised or ongoing trials in the EU Clinical Trials Information System with DualityBio as sponsor. Some are the same study as a ClinicalTrials.gov record above; the two registries share no common ID. Trials with a site in Ireland are listed first.

StudyPhaseStatusCountries
A Phase II, Multicenter, Open-Label Trial of DB-1311 in combination with BNT327 or DB-1305 in Participants with Advanced/Metastatic Solid Tumors
2025-523895-22-00 · CTIS ↗ · Neoplasms
Phase 2 Authorised Italy, Poland, France + 2 more
03

Drugs in DualityBio trials

15 compounds

Drugs and biologicals named as interventions in these trials, with the number of this sponsor's trials that name each one. Placebos and generic comparators are excluded.

04

Conditions in DualityBio trials

10 conditions
05

By trial register

RegisterTrialsRecruiting
Clinical trials in USA108
Clinical trials in China107
Clinical trials in UK10
EU register (CTIS)1—

A trial with sites in more than one country appears in each of those registers.

06

Other sponsors in Advanced Solid Tumor

SponsorTrials
BeOne Medicines11
Daiichi Sankyo7
TORL Biotherapeutics5
OncoC45
LaNova Medicines5
MediLink Therapeutics (Suzhou)4
Suzhou Zelgen Biopharmaceuticals4
BioNTech3
EMD Serono Research & Development Institute3
Hansoh BioMedical R&D Company3

Sponsors with the most current trials registered for this condition.

07

Questions about DualityBio trials

How many clinical trials does DualityBio sponsor?

DualityBio is the lead sponsor of 11 current trials on ClinicalTrials.gov in our USA, China and UK registers, and 1 authorised or ongoing trial in the EU register (CTIS), as of the registry sync on 26 September 2026. Completed and withdrawn studies are not counted.

Are DualityBio trials recruiting?

Yes. 8 of its 11 ClinicalTrials.gov trials are recruiting. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.

Which drugs is DualityBio testing?

Its current trials name 15 drugs and biologicals as interventions. The most frequent are DB-1303/BNT323 (3), Pumitamig (3), BNT324 (2), Capecitabine (2) and DB-1305/BNT325 (2). The number in brackets is how many of its trials name each drug.

Where does this information come from?

Every trial, status, phase and condition on this page is copied from public ClinicalTrials.gov and EU CTIS records by a daily sync, grouped by the sponsor name each registry records. It says nothing about the organisation beyond its registered trials, and it is not medical advice.

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How this page is built

Everything on this page is copied from public registry records — it is not written from memory, and nothing here describes the organisation beyond its registered trials. Each trial links to its own record so you can check it yourself.

This page is built automatically: a daily sync job reads the registry records behind our trial registers and groups every current trial by its lead sponsor name, ignoring legal-form suffixes such as Inc. or Ltd. A small, hand-checked list joins the same organisation's different registry names (for example its EU legal entity). There is no AI drafting and no per-sponsor editorial pass. The “last verified” date above is the timestamp of that sync, not a review date. Our general editorial approach is described in our editorial standards and corrections policy. The the registries data on this page was last retrieved on 26 Sep 2026.

Please verify before you rely on this. This page is general information for life-science and pharmaceutical professionals. It is not medical advice, and it has not been reviewed by a clinician — our editorial team holds life-science qualifications, not clinical ones. It is not exhaustive and may not reflect the most recent label change. Always check the official prescribing information (US Prescribing Information or EU SmPC) and speak to your doctor or pharmacist before acting on anything here. Drugs in the same class are not automatically interchangeable, and approvals, brand names and indications differ between the US, the EU/Ireland (EMA/HPRA) and other regions. Spotted an error? Tell us — we correct promptly and log it.