Tests DB-1303/BNT323 in adults with HER2-positive advanced solid tumors
Tests DB-1303/BNT323 for safety in adults with advanced HER2-positive solid tumors.
Plain-language title generated from the registry record
Registry title: A Phase 1/2a Study of DB-1303/BNT323 in Advanced/Metastatic Solid Tumors
Key facts
- Where
- Melbourne, Randwick, South Brisbane, and Sydney, AustraliaSee the 4 sites
- Phase
- Phase 1/2
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with an advanced, inoperable, returning or spread solid tumour that shows HER2 and has stopped responding to standard treatment, or has no standard treatment.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- Advanced, inoperable, recurrent or metastatic solid tumour with at least 1 measurable lesion (per RECIST 1.1). For the endometrial cancer group: it has progressed after at least 1 line of treatment including platinum-based therapy and an immune checkpoint inhibitor, with no more than 3 earlier lines.
- Earlier treatment
- The cancer did not respond to, or the person could not tolerate, standard treatment, or no standard treatment exists. Side effects from earlier cancer treatment must have settled to Grade 1 or baseline.
- Biomarker or test result
- A pathology-confirmed HER2-positive or HER2-expressing tumour (one group needs HER2-null). Earlier HER2 results, tumour samples, or a fresh biopsy for HER2 testing are needed.
Main reasons for not taking part
- Heart failure with symptoms (NYHA classes II-IV), serious heart rhythm problems needing treatment, or a heart attack or unstable angina within 6 months
- Clinically significant lung disease
- Uncontrolled infection needing IV antibiotics, antivirals or antifungals
- HIV infection with an AIDS-defining illness, or active viral hepatitis
- Brain metastases that are clinically active
Read by machine on 9 November 2026.
Where in Australia
- Monash HealthMelbourne, AustraliaNo longer taking part
- Scientia Clinical Research LtdRandwick, AustraliaNo longer taking part
- Integrated Clinical Oncology Network Pty Ltd (Icon)South Brisbane, AustraliaNo longer taking part
- Macquarie Clinical Trials UnitSydney, AustraliaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- DualityBio Inc.
- Trial code
- NCT05150691
- Record updated
- 27 August 2026
- Original description
This is a dose-escalation and dose-expansion Phase 1/2a trial to evaluate the safety and tolerability of DB-1303/BNT323 in subjects with advanced solid tumors that express HER2.Read full original descriptionShow less
A Phase 1/2a, Multicenter, Open-Label, First in Human Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of DB-1303/BNT323 in Patients With Advanced/Metastatic Solid Tumors
This is a dose-escalation and dose-expansion Phase 1/2a trial to evaluate the safety and tolerability of DB-1303/BNT323 in subjects with advanced solid tumors that express HER2.
Inclusion: Has a pathologically documented HER2-positive or HER2-expressing (except for cohort 2h where the requirement is HER2-null), advanced/unresectable, recurrent, or metastatic malignant solid tumor that is refractory to or intolerable with standard treatment, or for which no standard treatment is available; At least 1 measurable lesion (per RECIST 1.1); Provide signed informed consent; ECOG performance status (PS) of 0-1; LVEF ≥ 50% by ECHO or MUGA; Adequate organ functions; Provide pre-existing diagnosis of HER2 status or resected tumor samples or undergo fresh tumor biopsy for HER2 testing; Life expectancy of ≥ 3 months; Additional Inclusion Criteria for Part 2 Expansion Group 9:; Has pathologically documented advanced/unresectable, recurrent, or metastatic EC (including UCS and USPC) and has progressed on or after at least 1 line of systemic treatment including platinum-based therapy and exposure to ICI but no more than prior 3 lines of therapy for advanced/unresectable, or metastatic disease. Note: endocrine therapy will not qualify as a systemic therapy line.
Exclusion: History of myocardial infarction or unstable angina within 6 months before Day 1; Unresolved toxicities from previous anticancer therapy, defined as toxicities not yet resolved to NCI-CTCAE version 5.0, Grade ≤ 1 or baseline; History of symptomatic CHF (New York Heart Association [NYHA] classes II-IV) or serious cardiac arrhythmia requiring treatment; History of clinically significant lung diseases; Uncontrolled infection requiring IV antibiotics, antivirals, or antifungals; HIV infection with AIDS defining illness or active viral hepatitis; A known hypersensitivity to either the drug substances or inactive ingredients in the drug product; Part 2 (expansion) Only:Multiple primary malignancies within 3 years, except adequately resected non- melanoma skin cancer, curatively treated in-situ disease, other solid tumors curatively treated, or contralateral breast cancer; Average QTcF > 450 ms in males and > 470 ms in females; Clinically active brain metastases.