New hope for Hard-to-Treat HER2 cancers? early trial launches

NCT ID NCT05150691

Disease control Sponsor: DualityBio Inc. Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Aug 28, 2026 · Updated 2 times

Summary

This early-phase trial is testing a new drug called DB-1303/BNT323 in people with advanced HER2-positive solid tumors that have not responded to standard treatments. The study aims to find a safe dose and see if the drug can shrink tumors. About 800 participants will take part across multiple centers.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: DB-1303/BNT323 (a targeted drug that seeks out and attacks HER2-positive cancer cells)
What this could lead to: If successful, this could lead to a new treatment option for people with advanced HER2-positive cancers that have stopped responding to standard therapies.
What could go wrong: This is an early, first-in-human study, so safety and effectiveness are not yet proven. The drug may cause side effects or fail to shrink tumors.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 796 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2022

Expected to finish

Oct 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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: 1\. 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 Criteria: * History of symptomatic CHF (New York Heart Association \[NYHA\] classes II-IV) or serious cardiac arrhythmia requiring treatment. * History of myocardial infarction or unstable angina within 6 months before Day 1. * Average QTcF \> 450 ms in males and \> 470 ms in females * History of clinically significant lung diseases * Uncontrolled infection requiring IV antibiotics, antivirals, or antifungals. * HIV infection with AIDS defining illness or active viral hepatitis. * Clinically active brain metastases * Unresolved toxicities from previous anticancer therapy, defined as toxicities not yet resolved to NCI-CTCAE version 5.0, Grade ≤ 1 or baseline. * 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.

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Conditions

The condition(s) this trial relates to.

bile duct neoplasm Biliary Tract Neoplasms breast neoplasm carcinoma cholangiocarcinoma digestive system neoplasm endometrium neoplasm gastric neoplasm Liver Neoplasms neoplasm Neoplasm Metastasis non-small cell lung carcinoma Recurrence

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

HER2-positive advanced solid tumor

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

46 sites. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

Open the record ↗
A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

1st affliated hospital of Zhejiang University
RECRUITING

Hangzhou, Zhejiang, China
AHN West Penn Hospital
ACTIVE_NOT_RECRUITING

Pittsburgh, Pennsylvania, 15224, United States
Advanced Research LLC
ACTIVE_NOT_RECRUITING

Coral Springs, Florida, 33065, United States
Affiliated Hospital of Hebei University
RECRUITING

Baoding, Hebei, China
Affiliated Hospital of Jiangnan University
RECRUITING

Wuxi, Jiangsu, China
Affiliated hospital of Jining medical university
RECRUITING

Jining, Shandong, China
Anhui provincial hospital
RECRUITING

Hefei, Anhui, China
Anyang Tumor Hospital
RECRUITING

Anyang, Henan, China
Asan Medical Center
ACTIVE_NOT_RECRUITING

Seoul, Songpa-gu, 05505, South Korea
BRCR Global Puerto Rico LLC.
WITHDRAWN

Mayagüez, 00682, Puerto Rico
BRCR Medical Center Inc.
ACTIVE_NOT_RECRUITING

Plantation, Florida, 33322, United States
BRCR Medical Center Inc.
ACTIVE_NOT_RECRUITING

Tamarac, Florida, 33321, United States
Beijing Cancer Hospital
RECRUITING

Beijing, Beijing Municipality, China
Beth Israel Deaconess Medical Center
ACTIVE_NOT_RECRUITING

Boston, Massachusetts, 02215, United States
California Research Institute
ACTIVE_NOT_RECRUITING

Los Angeles, California, 90027, United States
Cancer Hospital Chinese Academy of Medical Science
RECRUITING

Beijing, Beijing Municipality, China
Cancer Hospital of Guangxi Medical University
RECRUITING

Nanning, Guangxi, China
Central hospital affiliated to Shandong first medical university
RECRUITING

Jinan, Shandong, China
Changhua Christian Hospital
ACTIVE_NOT_RECRUITING

Changhua, Changhua County, 50006, Taiwan
Changzhou Tumor Hospital
WITHDRAWN

Changzhou, Jiangsu, China
Chongqing University Cancer Hospital
RECRUITING

Chongqing, Chongqing Municipality, China
Clinical Trial Network
WITHDRAWN

Houston, Texas, 77074, United States
D&H Cancer Research Center LLC
ACTIVE_NOT_RECRUITING

Margate, Florida, 33063, United States
David C. Pratt Cancer Center
ACTIVE_NOT_RECRUITING

St Louis, Missouri, 63141, United States
Fudan University
RECRUITING

Shanghai, Shanghai Municipality, China
Gabrail Cancer Center
ACTIVE_NOT_RECRUITING

Canton, Ohio, 44718, United States
Gansu Provincial Maternity and Child-care Hospital
RECRUITING

Lanzhou, Gansu, China
HCA Mercy Hospital
WITHDRAWN

Miami, Florida, 33133, United States
Helios Clinical Research
ACTIVE_NOT_RECRUITING

Cerritos, California, 90703, United States
Henan cancer Hospital
RECRUITING

Zhengzhou, Hehan, China
Holy Cross Hospital
WITHDRAWN

Silver Spring, Maryland, 20910, United States
Huizhou First Hospital
RECRUITING

Guangzhou, Guangdong, China
Hunan Cancer Hospital
RECRUITING

Changsha, Hunan, China
Hunan People's Provincial Hospital
RECRUITING

Changsha, Hunan, China
Integrated Clinical Oncology Network Pty Ltd (Icon)
ACTIVE_NOT_RECRUITING

South Brisbane, Queensland, 4101, Australia
Jiangxi maternal and child health hospital
RECRUITING

Nanchang, Jiangxi, China
Jilin Cancer Hospital
RECRUITING

Changchun, Jilin, China
Jinan Central Hospital
RECRUITING

Jinan, Shandong, China
Kaohsiung Veterans General Hospital
ACTIVE_NOT_RECRUITING

Kaohsiung City, Zuoying District, 81362, Taiwan
Kapi'olani Medical Center for Women and Children
ACTIVE_NOT_RECRUITING

Honolulu, Hawaii, 96826, United States
Laura & Isaac Perlmutter Cancer Center at NYC Langone Health
ACTIVE_NOT_RECRUITING

New York, New York, 10016, United States
Liaoning cancer hospital & Institute
RECRUITING

Shenyang, Liaoning, China
Linyi Tumor Hospital
RECRUITING

Liaocheng, Shandong, China
Mackay Memorial Hospital-Taipei
ACTIVE_NOT_RECRUITING

Taipei, Zhongshan District, 10449, Taiwan
Macquarie Clinical Trials Unit
ACTIVE_NOT_RECRUITING

Sydney, New South Wales, 2109, Australia
Massachusetts General Hospital
ACTIVE_NOT_RECRUITING

Boston, Massachusetts, 02214, United States
Memorial Sloan Kettering Cancer Center
ACTIVE_NOT_RECRUITING

New York, New York, 10065, United States
Monash Health
ACTIVE_NOT_RECRUITING

Melbourne, Victoria, 3168, Australia
NEXT Virginia
ACTIVE_NOT_RECRUITING

Fairfax, Virginia, 22031, United States
National Cancer Center
ACTIVE_NOT_RECRUITING

Gyeonggi-do, Ilsandong-gu, 10408, South Korea
National Taiwan University Hospital
ACTIVE_NOT_RECRUITING

Taipei, Zhongzheng District, 100225, Taiwan
North Shore Hematology Oncology Associate P.C. DBA New York Cancer and Blood Specialists
ACTIVE_NOT_RECRUITING

Shirley, New York, 11967, United States
Northwell Health
WITHDRAWN

Lake Success, New York, 11042, United States
Oncology and Hematology of South Texas, PA
ACTIVE_NOT_RECRUITING

Laredo, Texas, 78041, United States
Profound Research LLC/Michigan Hematology & Oncology Consultants
WITHDRAWN

Dearborn, Michigan, 48126, United States
Regional Medical Oncology Center
WITHDRAWN

Wilson, North Carolina, 27893, United States
Rittenhouse Hematology Oncology
WITHDRAWN

Philadelphia, Pennsylvania, 19107, United States
Samsung Medical Center
ACTIVE_NOT_RECRUITING

Seoul, Gangnam-gu, 06351, South Korea
Scientia Clinical Research LTD
ACTIVE_NOT_RECRUITING

Randwick, New South Wales, 2031, Australia
Seoul National University Bundang Hospital
ACTIVE_NOT_RECRUITING

Gyeonggi-do, Bundang-gu, 13620, South Korea
Severance Hospital
ACTIVE_NOT_RECRUITING

Seoul, Seodaemun-gu, 03722, South Korea
Shandong Cancer hospital & institute
RECRUITING

Jinan, Shandong, China
Shanghai Tenth people's Hospital
RECRUITING

Shanghai, Shanghai Municipality, China
Sharp Memorial Hospital
ACTIVE_NOT_RECRUITING

San Diego, California, 92123, United States
Southeastern Regional Medical Center, LLC
ACTIVE_NOT_RECRUITING

Newnan, Georgia, 30265, United States
Sun Yat-Sen Memorial Hospital of Zhongshan University
RECRUITING

Guangzhou, Guangdong, China
Swedish Cancer Institute
ACTIVE_NOT_RECRUITING

Seattle, Washington, 98104, United States
Taipei Medical University Hospital
ACTIVE_NOT_RECRUITING

Taipei, Xinyi District, 110301, Taiwan
Taipei Medical University-Shuang Ho Hospital
ACTIVE_NOT_RECRUITING

Taipei, Zhonghe District, 235041, Taiwan
Taipei Veterans General Hospital
ACTIVE_NOT_RECRUITING

Taipei, Beitou District, 11217, Taiwan
Tennessee Oncology
ACTIVE_NOT_RECRUITING

Nashville, Tennessee, 37203, United States
The Affiliated Hospital of Xuzhou Medical College
RECRUITING

Xuzhou, Jiangsu, China
The First Affiliated Hospital Of Xi'an Jiaotong University
RECRUITING

Xi'an, Shaanxi, China
The First Affiliated Hospital of Wenzhou Medical University
WITHDRAWN

Wenzhou, Zhejiang, China
The First Affiliated Hospital of Zhengzhou University
RECRUITING

Zhengzhou, Henan, China
The First Hospital of China Medical University
RECRUITING

Shenyang, Liaoning, China
The First Hospital of Jilin University
RECRUITING

Hongcun, Changchun, China
The First affiliated Hospital of Chongqing Medical University
RECRUITING

Chongqing, Chongqing Municipality, China
The First affiliated hospital of Xiamen University
RECRUITING

Xiamen, Fujian, China
The First affiliated hospital, Sun Yat-sen University
RECRUITING

Guangzhou, Guangdong, China
The First people's hospital of Yulin
RECRUITING

Yulin, Guangxi, China
The Obstetrics & Gynecology Hospital Affiliated to Fudan University
RECRUITING

Shanghai, Shanghai Municipality, China
The Oncology Institute of Hope and Innovation
ACTIVE_NOT_RECRUITING

Lakeland, Florida, 33812, United States
The Second Hospital of Anhui Medical University
RECRUITING

Hefei, Anhui, China
The Third Hospital of Nanchang
RECRUITING

Nanchang, Jiangxi, China
The first affiliated hospital of Bengbu medical college
RECRUITING

Bengbu, Anhui, China
The second affiliated hospital of Zhejiang University School of Medicine
RECRUITING

Hangzhou, Zhejiang, China
Thomas Jefferson University
ACTIVE_NOT_RECRUITING

Philadelphia, Pennsylvania, 19107, United States
Tianjin Medical university cancer institute & hospital
RECRUITING

Tianjin, Tianjin Municipality, China
Union hospital Tongji Medical college Huazhong university of science and technology
RECRUITING

Wuhan, Hubei, China
University of Chicago
ACTIVE_NOT_RECRUITING

Chicago, Illinois, 60637, United States
University of Oklahoma
ACTIVE_NOT_RECRUITING

Oklahoma City, Oklahoma, 73104, United States
Washington Cancer Institute at MedStar Washington Hospital Center
ACTIVE_NOT_RECRUITING

Washington D.C., District of Columbia, 20010, United States
Women's Cancer Care
WITHDRAWN

Covington, Louisiana, 70433, United States
Women's Cancer Center of Nevada
WITHDRAWN

Las Vegas, Nevada, 89106, United States
Women's hospital school of medicine Zhejiang University
RECRUITING

Hangzhou, Zhejiang, China
Xiangya Hospital Central South University
RECRUITING

Changsha, Hunan, China
Xuzhou Cancer Hospital
WITHDRAWN

Xuzhou, Jiangsu, China
Yantai Yuhuangding Hospital
WITHDRAWN

Yantai, Shangdong, China
Yunnan Provincial Cancer Hospital
RECRUITING

Kunming, Yunnan, China
Zhejiang Cancer Hospital
RECRUITING

Hangzhou, Zhejiang, China
Zibo Central hospital
RECRUITING

Zibo, Shandong, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.

New targeted drug ZV0203 enters first human tests for Hard-to-Treat HER2 cancers