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Taking people in ChinaPhase 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.

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
Anyang, Baoding, Beijing, Bengbu, Changchun, Changsha, Changzhou, Chongqing, Guangzhou, Hangzhou, Hefei, Hongcun, Jinan, Jining, Kunming, Lanzhou, Liaocheng, Nanchang, Nanning, Shanghai, Shenyang, Tianjin, Wenzhou, Wuhan, Wuxi, Xi’an, Xiamen, Xuzhou, Yantai, Yulin, Zhengzhou, and Zibo, ChinaSee the 50 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 12 November 2026.

Where in China

  • Anyang Tumor HospitalAnyang, ChinaContact: Britney WinterbergerTaking people
  • Affiliated Hospital of Hebei UniversityBaoding, ChinaContact: Britney WinterbergerTaking people
  • Beijing Cancer HospitalBeijing, ChinaContact: Britney WinterbergerTaking people
  • Cancer Hospital Chinese Academy of Medical ScienceBeijing, ChinaContact: Britney WinterbergerTaking people
  • The First Affiliated Hospital of Bengbu Medical CollegeBengbu, ChinaContact: Britney WinterbergerTaking people
  • Jilin Cancer HospitalChangchun, ChinaContact: Britney WinterbergerTaking people
  • Hunan Cancer HospitalChangsha, ChinaContact: Britney WinterbergerTaking people
  • Hunan People's Provincial HospitalChangsha, ChinaContact: Britney WinterbergerTaking people
  • Xiangya Hospital Central South UniversityChangsha, ChinaContact: Britney WinterbergerTaking people
  • Changzhou Tumor HospitalChangzhou, ChinaContact: Britney WinterbergerNo longer taking part
  • Chongqing University Cancer HospitalChongqing, ChinaContact: Britney WinterbergerTaking people
  • The First Affiliated Hospital of Chongqing Medical UniversityChongqing, ChinaContact: Britney WinterbergerTaking people
  • Huizhou First HospitalGuangzhou, ChinaContact: Britney WinterbergerTaking people
  • Sun Yat-Sen Memorial Hospital of Zhongshan UniversityGuangzhou, ChinaContact: Britney WinterbergerTaking people
  • The First Affiliated Hospital, Sun Yat-sen UniversityGuangzhou, ChinaContact: Britney WinterbergerTaking people
  • 1st affliated hospital of Zhejiang UniversityHangzhou, ChinaContact: Britney WinterbergerTaking people
  • The Second Affiliated Hospital of Zhejiang University School of MedicineHangzhou, ChinaContact: Britney WinterbergerTaking people
  • Women's hospital school of medicine Zhejiang UniversityHangzhou, ChinaContact: Britney WinterbergerTaking people
  • Zhejiang Cancer HospitalHangzhou, ChinaContact: Britney WinterbergerTaking people
  • Anhui Provincial HospitalHefei, ChinaContact: Britney WinterbergerTaking people
  • The Second Hospital of Anhui Medical UniversityHefei, ChinaContact: Britney WinterbergerTaking people
  • The First Hospital of Jilin UniversityHongcun, ChinaContact: Britney WinterbergerTaking people
  • Central Hospital Affiliated to Shandong First Medical UniversityJinan, ChinaContact: Britney WinterbergerTaking people
  • Jinan Central HospitalJinan, ChinaContact: Britney WinterbergerTaking people
  • Shandong Cancer Hospital & instituteJinan, ChinaContact: Britney WinterbergerTaking people
  • Affiliated Hospital of Jining Medical UniversityJining, ChinaContact: Britney WinterbergerTaking people
  • Yunnan Provincial Cancer HospitalKunming, ChinaContact: Britney WinterbergerTaking people
  • Gansu Provincial Maternity and Child-care HospitalLanzhou, ChinaContact: Britney WinterbergerTaking people
  • Linyi Tumor HospitalLiaocheng, ChinaContact: Britney WinterbergerTaking people
  • Jiangxi maternal and child health hospitalNanchang, ChinaContact: Britney WinterbergerTaking people
  • The Third Hospital of NanchangNanchang, ChinaContact: Britney WinterbergerTaking people
  • Cancer Hospital of Guangxi Medical UniversityNanning, ChinaContact: Britney WinterbergerTaking people
  • Fudan UniversityShanghai, ChinaContact: Britney WinterbergerTaking people
  • Shanghai Tenth People's HospitalShanghai, ChinaContact: Britney WinterbergerTaking people
  • The Obstetrics & Gynecology Hospital Affiliated to Fudan UniversityShanghai, ChinaContact: Britney WinterbergerTaking people
  • Liaoning Cancer Hospital & InstituteShenyang, ChinaContact: Britney WinterbergerTaking people
  • The First Hospital of China Medical UniversityShenyang, ChinaContact: Britney WinterbergerTaking people
  • Tianjin Medical University Cancer Institute & HospitalTianjin, ChinaContact: Britney WinterbergerTaking people
  • The First Affiliated Hospital of Wenzhou Medical UniversityWenzhou, ChinaContact: Britney WinterbergerNo longer taking part
  • Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyWuhan, ChinaContact: Britney WinterbergerTaking people
  • Affiliated Hospital of Jiangnan UniversityWuxi, ChinaContact: Britney WinterbergerTaking people
  • The First Affiliated Hospital of Xi'an Jiaotong UniversityXi’an, ChinaContact: Britney WinterbergerTaking people
  • The First Affiliated hospital of Xiamen UniversityXiamen, ChinaContact: Britney WinterbergerTaking people
  • The Affiliated Hospital of Xuzhou Medical CollegeXuzhou, ChinaContact: Britney WinterbergerTaking people
  • Xuzhou Cancer HospitalXuzhou, ChinaContact: Britney WinterbergerNo longer taking part
  • Yantai Yuhuangding HospitalYantai, ChinaContact: Britney WinterbergerNo longer taking part
  • The First people's hospital of YulinYulin, ChinaContact: Britney WinterbergerTaking people
  • Henan Cancer HospitalZhengzhou, ChinaContact: Britney WinterbergerTaking people
  • The First Affiliated Hospital of Zhengzhou UniversityZhengzhou, ChinaContact: Britney WinterbergerTaking people
  • Zibo Central hospitalZibo, ChinaContact: Britney WinterbergerTaking people

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

Trial 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.

ClinicalTrials.gov NCT05150691