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Taking peoplePhase 1/2

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.

Key facts

Who runs it
DualityBio Inc.
Where
Changhua, Kaohsiung City, and Taipei, TaiwanSee the 7 sitesAlso in 5 other countries, 95 sites
Trial code
Registry title
A Phase 1/2a Study of DB-1303/BNT323 in Advanced/Metastatic Solid Tumors
Status
Recruiting
Phase
Phase 1/2
People taking part
796 people, planned
Started
31 Jan 2022
Expected to end
Oct 2027
Type of study
Interventional, 24 groups
Treatments tested
  • DB-1303/BNT323
  • Pertuzumab Injection
  • Ritonavir
  • Itraconazole
Record updated
27 August 2026

Who can take part

AI summary

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

The registry criteria, word for word

Show all 19 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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

Where in Taiwan

Also in 5 other countries, 95 sites

  • Changhua Christian HospitalChanghua, TaiwanContact: Britney WinterbergerNo longer taking part
  • Kaohsiung Veterans General HospitalKaohsiung City, TaiwanContact: Britney WinterbergerNo longer taking part
  • Mackay Memorial Hospital-TaipeiTaipei, TaiwanContact: Britney WinterbergerNo longer taking part
  • National Taiwan University HospitalTaipei, TaiwanContact: Britney WinterbergerNo longer taking part
  • Taipei Medical University HospitalTaipei, TaiwanContact: Britney WinterbergerNo longer taking part
  • Taipei Medical University-Shuang Ho HospitalTaipei, TaiwanContact: Britney WinterbergerNo longer taking part
  • Taipei Veterans General HospitalTaipei, TaiwanContact: Britney WinterbergerNo longer taking part

About the trial

What the trial wants to find out

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.

The 24 groups in the trial

  • DB-1303/BNT323 Dose Level 1Treatment being tested

    Enrolled Subjects will receive a single-dose of DB-1303/BNT323 at Dose Level 1 on Day 1 of each cycle Q3W

    Treatment: DB-1303/BNT323

  • DB-1303/BNT323 Dose Level 2Treatment being tested

    Enrolled Subjects will receive a single-dose of DB-1303/BNT323 at Dose Level 2 on Day 1 of each cycle Q3W

    Treatment: DB-1303/BNT323

  • DB-1303/BNT323 Dose Level 3Treatment being tested

    Enrolled Subjects will receive a single-dose of DB-1303/BNT323 at Dose Level 3 on Day 1 of each cycle Q3W

    Treatment: DB-1303/BNT323

  • DB-1303/BNT323 Dose Level 4Treatment being tested

    Enrolled Subjects will receive a single-dose of DB-1303/BNT323 at Dose Level 4 on Day 1 of each cycle Q3W

    Treatment: DB-1303/BNT323

  • DB-1303/BNT323 Dose Level 5Treatment being tested

    Enrolled Subjects will receive a single-dose of DB-1303/BNT323 at Dose Level 5 on Day 1 of each cycle Q3W

    Treatment: DB-1303/BNT323

  • DB-1303/BNT323 Dose Expansion 1Treatment being tested

    Enrolled Subjects will be randomized to receive a single-dose of DB-1303/BNT323 on a selected dose level 1 or dose level 2 Day 1 of each cycle Q3W

    Treatment: DB-1303/BNT323

  • DB-1303/BNT323 Dose Expansion 2Treatment being tested

    Enrolled Subjects will receive a single-dose of DB-1303/BNT323 on a selected dose level (RP2D) Day 1 of each cycle Q3W

    Treatment: DB-1303/BNT323

  • DB-1303/BNT323 Dose Expansion 3Treatment being tested

    Enrolled Subjects will receive a single-dose of DB-1303/BNT323 on a selected dose level (RP2D) Day 1 of each cycle Q3W

    Treatment: DB-1303/BNT323

  • DB-1303/BNT323 Dose Expansion 4Treatment being tested

    Enrolled Subjects will receive a single-dose of DB-1303/BNT323 on a selected dose level (RP2D) Day 1 of each cycle Q3W

    Treatment: DB-1303/BNT323

  • DB-1303/BNT323 Dose Expansion 5Treatment being tested

    Enrolled Subjects will receive a single-dose of DB-1303/BNT323 on a selected dose level (RP2D) Day 1 of each cycle Q3W

    Treatment: DB-1303/BNT323

  • DB-1303/BNT323 Dose Level 6Treatment being tested

    Enrolled Subjects will receive a single-dose of DB-1303/BNT323 at Dose Level 6 on Day 1 of each cycle Q3W

    Treatment: DB-1303/BNT323

  • DB-1303/BNT323 Dose Level 7Treatment being tested

    Enrolled Subjects will receive a single-dose of DB-1303/BNT323 at Dose Level 7 on Day 1 of each cycle Q3W

    Treatment: DB-1303/BNT323

  • DB-1303/BNT323 Dose Expansion 6Treatment being tested

    Enrolled Subjects will receive a single-dose of DB-1303/BNT323 on a selected dose level (RP2D) Day 1 of each cycle Q3W

    Treatment: DB-1303/BNT323

  • DB-1303/BNT323 Dose Expansion 7Treatment being tested

    Enrolled Subjects will receive a single-dose of DB-1303/BNT323 on a selected dose level (RP2D) Day 1 of each cycle Q3W

    Treatment: DB-1303/BNT323

  • DB-1303/BNT323 Dose Expansion 8Treatment being tested

    Enrolled Subjects will receive a single-dose of DB-1303/BNT323 on a selected dose level (RP2D) Day 1 of each cycle Q3W

    Treatment: DB-1303/BNT323

  • DB-1303/BNT323 Dose Expansion 9Treatment being tested

    Enrolled Subjects will be randomized to receive a single-dose of DB-1303/BNT323 on a selected dose level 1 or dose level 2 on Day 1 of each cycle Q3W

    Treatment: DB-1303/BNT323

  • DB-1303/BNT323 Dose Expansion 10Treatment being tested

    Enrolled Subjects will receive a single-dose of DB-1303/BNT323 on a selected dose level (RP2D) Day 1 of each cycle Q3W along with ritonavir or itraconazole to assess the DDI potential

    Treatment: DB-1303/BNT323, Ritonavir, and Itraconazole

  • DB-1303/BNT323 Dose Expansion 11Treatment being tested

    Enrolled Subjects will receive a single-dose of DB-1303/BNT323 on a selected dose level (RP2D) Day 1 of each cycle Q3W

    Treatment: DB-1303/BNT323

  • DB-1303/BNT323 Dose Expansion 12Treatment being tested

    Enrolled Subjects will receive a single-dose of DB-1303/BNT323 on a selected dose level 1 or dose level 2 in combination with Pertuzumab on Day 1 of each cycle Q3W

    Treatment: DB-1303/BNT323 and Pertuzumab Injection

  • DB-1303/BNT323 Dose Expansion 13Treatment being tested

    Enrolled Subjects will receive a single-dose of DB-1303/BNT323 on a selected dose level (RP2D) Day 1 of each cycle Q3W

    Treatment: DB-1303/BNT323

  • DB-1303/BNT323 Dose Expansion 14Treatment being tested

    China Only:Subjects who were previously treated with trastuzumab and taxane will receive a single-dose of DB-1303/BNT323 on a selected dose level (RP2D) Day 1 of each cycle Q3W

    Treatment: DB-1303/BNT323

  • DB-1303/BNT323 Dose Expansion 15Treatment being tested

    China Only: Enrolled Subjects will receive a single-dose of DB-1303/BNT323 on a selected dose level (RP2D) Day 1 of each cycle Q3W

    Treatment: DB-1303/BNT323

  • DB-1303/BNT323 Dose Expansion 16Treatment being tested

    Enrolled Subjects will receive a single-dose of DB-1303/BNT323 on a selected dose level (RP2D) Day 1 of each cycle Q3W

    Treatment: DB-1303/BNT323

  • DB-1303/BNT323 Dose Expansion 17Treatment being tested

    Enrolled Subjects will receive a single-dose of DB-1303/BNT323 on a selected dose level (RP2D) Day 1 of each cycle Q3W

    Treatment: DB-1303/BNT323

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
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
Plain-language title
Tests DB-1303/BNT323 in adults with HER2-positive advanced solid tumorsGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
27 August 2026