RecruitingPhase I/IIEN original

A Phase 1/2a Study of DB-1303/BNT323 in Advanced/Metastatic Solid Tumors

⚠️

This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.

About the trial

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.

Original English text from ClinicalTrials.gov

Who can (and can't) join

✓ Qualifies

  • Osoby z zaawansowanym lub rozprzestrzenionym rakiem, który nie zareagował na standardowe leczenie lub dla którego nie ma dostępnych standardowych opcji.
  • Rak musi mieć cechę HER2 (w niektórych przypadkach dopuszczalny jest brak tej cechy).
  • W badaniu można uczestniczyć, jeśli choroba jest mierzalna.
  • Stan ogólny pacjenta pozwala na udział w badaniu (ocena ECOG 0-1).
  • Serce musi działać prawidłowo (wynik LVEF ≥ 50%).
  • Należy wyrazić pisemną zgodę na udział w badaniu.
  • Osoby z rakiem endometrium lub szyjki macicy, które już przeszły leczenie.

✗ Disqualifies

  • Problemy z sercem, takie jak niewydolność serca (klasy II-IV) lub poważne zaburzenia rytmu serca.
  • Przebyty zawał serca lub niestabilna dławica piersiowa w ciągu ostatnich 6 miesięcy.
  • Problemy z wątrobą, nerkami lub innymi organami, które nie pozwalają na bezpieczne podanie leku.
  • Znaczne problemy z płucami.
  • Niekontrolowane infekcje wymagające leczenia.
  • Aktywne przerzuty do mózgu.
  • Nieustępujące działania niepożądane po wcześniejszym leczeniu nowotworu.
  • Znana nadwrażliwość na lek lub jego składniki.

Simplified criteria — AI translation

Trial details

Minimum age
18 Years
Last updated (source)
January 28, 2026
Sex
No restrictions

Therapies / drugs in trial

Locations (102)

Helios Clinical Research

Cerritos, United States

California Research Institute

Los Angeles, United States

Sharp Memorial Hospital

San Diego, United States

Washington Cancer Institute at MedStar Washington Hospital Center

Washington D.C., United States

Advanced Research LLC

Coral Springs, United States

The Oncology Institute of Hope and Innovation

Lakeland, United States

D&H Cancer Research Center LLC

Margate, United States

HCA Mercy Hospital

Miami, United States

BRCR Medical Center Inc.

Plantation, United States

BRCR Medical Center Inc.

Tamarac, United States

Southeastern Regional Medical Center, LLC

Newnan, United States

Kapi'olani Medical Center for Women and Children

Honolulu, United States

University of Chicago

Chicago, United States

Women's Cancer Care

Covington, United States

Holy Cross Hospital

Silver Spring, United States

Massachusetts General Hospital

Boston, United States

Beth Israel Deaconess Medical Center

Boston, United States

Profound Research LLC/Michigan Hematology & Oncology Consultants

Dearborn, United States

David C. Pratt Cancer Center

St Louis, United States

Women's Cancer Center of Nevada

Las Vegas, United States

Northwell Health

Lake Success, United States

Laura & Isaac Perlmutter Cancer Center at NYC Langone Health

New York, United States

Memorial Sloan Kettering Cancer Center

New York, United States

North Shore Hematology Oncology Associate P.C. DBA New York Cancer and Blood Specialists

Shirley, United States

Regional Medical Oncology Center

Wilson, United States

Gabrail Cancer Center

Canton, United States

University of Oklahoma

Oklahoma City, United States

Rittenhouse Hematology Oncology

Philadelphia, United States

Thomas Jefferson University

Philadelphia, United States

AHN West Penn Hospital

Pittsburgh, United States

Tennessee Oncology

Nashville, United States

Clinical Trial Network

Houston, United States

Oncology and Hematology of South Texas, PA

Laredo, United States

NEXT Virginia

Fairfax, United States

Swedish Cancer Institute

Seattle, United States

Scientia Clinical Research LTD

Randwick, Australia

Macquarie Clinical Trials Unit

Sydney, Australia

Integrated Clinical Oncology Network Pty Ltd (Icon)

South Brisbane, Australia

Monash Health

Melbourne, Australia

The first affiliated hospital of Bengbu medical college

Bengbu, China

Anhui provincial hospital

Hefei, China

The Second Hospital of Anhui Medical University

Hefei, China

Beijing Cancer Hospital

Beijing, China

Cancer Hospital Chinese Academy of Medical Science

Beijing, China

The First Hospital of Jilin University

Hongcun, China

Chongqing University Cancer Hospital

Chongqing, China

The First affiliated Hospital of Chongqing Medical University

Chongqing, China

The First affiliated hospital of Xiamen University

Xiamen, China

Gansu Provincial Maternity and Child-care Hospital

Lanzhou, China

Huizhou First Hospital

Guangzhou, China

Sun Yat-Sen Memorial Hospital of Zhongshan University

Guangzhou, China

The First affiliated hospital, Sun Yat-sen University

Guangzhou, China

Cancer Hospital of Guangxi Medical University

Nanning, China

The First people's hospital of Yulin

Yulin, China

Affiliated Hospital of Hebei University

Baoding, China

Henan cancer Hospital

Zhengzhou, China

Anyang Tumor Hospital

Anyang, China

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, China

Union hospital Tongji Medical college Huazhong university of science and technology

Wuhan, China

Hunan Cancer Hospital

Changsha, China

Hunan People's Provincial Hospital

Changsha, China

Xiangya Hospital Central South University

Changsha, China

Changzhou Tumor Hospital

Changzhou, China

Affiliated Hospital of Jiangnan University

Wuxi, China

The Affiliated Hospital of Xuzhou Medical College

Xuzhou, China

Xuzhou Cancer Hospital

Xuzhou, China

Jiangxi maternal and child health hospital

Nanchang, China

The Third Hospital of Nanchang

Nanchang, China

Jilin Cancer Hospital

Changchun, China

Liaoning cancer hospital & Institute

Shenyang, China

The First Hospital of China Medical University

Shenyang, China

The First Affiliated Hospital Of Xi'an Jiaotong University

Xi'an, China

Central hospital affiliated to Shandong first medical university

Jinan, China

Jinan Central Hospital

Jinan, China

Shandong Cancer hospital & institute

Jinan, China

Affiliated hospital of Jining medical university

Jining, China

Linyi Tumor Hospital

Liaocheng, China

Zibo Central hospital

Zibo, China

Yantai Yuhuangding Hospital

Yantai, China

Fudan University

Shanghai, China

Shanghai Tenth people's Hospital

Shanghai, China

The Obstetrics & Gynecology Hospital Affiliated to Fudan University

Shanghai, China

Tianjin Medical university cancer institute & hospital

Tianjin, China

Yunnan Provincial Cancer Hospital

Kunming, China

1st affliated hospital of Zhejiang University

Hangzhou, China

The second affiliated hospital of Zhejiang University School of Medicine

Hangzhou, China

Women's hospital school of medicine Zhejiang University

Hangzhou, China

Zhejiang Cancer Hospital

Hangzhou, China

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, China

BRCR Global Puerto Rico LLC.

Mayagüez, Puerto Rico

Seoul National University Bundang Hospital

Gyeonggi-do, South Korea

Samsung Medical Center

Seoul, South Korea

National Cancer Center

Gyeonggi-do, South Korea

Severance Hospital

Seoul, South Korea

Asan Medical Center

Seoul, South Korea

Taipei Veterans General Hospital

Taipei, Taiwan

Changhua Christian Hospital

Changhua, Taiwan

Taipei Medical University Hospital

Taipei, Taiwan

Taipei Medical University-Shuang Ho Hospital

Taipei, Taiwan

Mackay Memorial Hospital-Taipei

Taipei, Taiwan

National Taiwan University Hospital

Taipei, Taiwan

Kaohsiung Veterans General Hospital

Kaohsiung City, Taiwan

Trial contact

Contact information from ClinicalTrials.gov. Contact in English.

Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/1/2026.