A Phase 1/2a Study of DB-1303/BNT323 in Advanced/Metastatic Solid Tumors
NCT ID: NCT05150691
Last Updated: 2026-01-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
796 participants
INTERVENTIONAL
2022-01-31
2027-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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DB-1303/BNT323 Dose Expansion 15
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
DB-1303/BNT323
Administered IV
DB-1303/BNT323 Dose Expansion 16
Enrolled Subjects will receive a single-dose of DB-1303/BNT323 on a selected dose level (RP2D) Day 1 of each cycle Q3W
DB-1303/BNT323
Administered IV
DB-1303/BNT323 Dose Expansion 17
Enrolled Subjects will receive a single-dose of DB-1303/BNT323 on a selected dose level (RP2D) Day 1 of each cycle Q3W
DB-1303/BNT323
Administered IV
DB-1303/BNT323 Dose Level 1
Enrolled Subjects will receive a single-dose of DB-1303/BNT323 at Dose Level 1 on Day 1 of each cycle Q3W
DB-1303/BNT323
Administered IV
DB-1303/BNT323 Dose Level 2
Enrolled Subjects will receive a single-dose of DB-1303/BNT323 at Dose Level 2 on Day 1 of each cycle Q3W
DB-1303/BNT323
Administered IV
DB-1303/BNT323 Dose Level 3
Enrolled Subjects will receive a single-dose of DB-1303/BNT323 at Dose Level 3 on Day 1 of each cycle Q3W
DB-1303/BNT323
Administered IV
DB-1303/BNT323 Dose Level 4
Enrolled Subjects will receive a single-dose of DB-1303/BNT323 at Dose Level 4 on Day 1 of each cycle Q3W
DB-1303/BNT323
Administered IV
DB-1303/BNT323 Dose Level 5
Enrolled Subjects will receive a single-dose of DB-1303/BNT323 at Dose Level 5 on Day 1 of each cycle Q3W
DB-1303/BNT323
Administered IV
DB-1303/BNT323 Dose Expansion 1
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
DB-1303/BNT323
Administered IV
DB-1303/BNT323 Dose Expansion 2
Enrolled Subjects will receive a single-dose of DB-1303/BNT323 on a selected dose level (RP2D) Day 1 of each cycle Q3W
DB-1303/BNT323
Administered IV
DB-1303/BNT323 Dose Expansion 3
Enrolled Subjects will receive a single-dose of DB-1303/BNT323 on a selected dose level (RP2D) Day 1 of each cycle Q3W
DB-1303/BNT323
Administered IV
DB-1303/BNT323 Dose Expansion 4
Enrolled Subjects will receive a single-dose of DB-1303/BNT323 on a selected dose level (RP2D) Day 1 of each cycle Q3W
DB-1303/BNT323
Administered IV
DB-1303/BNT323 Dose Expansion 5
Enrolled Subjects will receive a single-dose of DB-1303/BNT323 on a selected dose level (RP2D) Day 1 of each cycle Q3W
DB-1303/BNT323
Administered IV
DB-1303/BNT323 Dose Level 6
Enrolled Subjects will receive a single-dose of DB-1303/BNT323 at Dose Level 6 on Day 1 of each cycle Q3W
DB-1303/BNT323
Administered IV
DB-1303/BNT323 Dose Level 7
Enrolled Subjects will receive a single-dose of DB-1303/BNT323 at Dose Level 7 on Day 1 of each cycle Q3W
DB-1303/BNT323
Administered IV
DB-1303/BNT323 Dose Expansion 6
Enrolled Subjects will receive a single-dose of DB-1303/BNT323 on a selected dose level (RP2D) Day 1 of each cycle Q3W
DB-1303/BNT323
Administered IV
DB-1303/BNT323 Dose Expansion 7
Enrolled Subjects will receive a single-dose of DB-1303/BNT323 on a selected dose level (RP2D) Day 1 of each cycle Q3W
DB-1303/BNT323
Administered IV
DB-1303/BNT323 Dose Expansion 8
Enrolled Subjects will receive a single-dose of DB-1303/BNT323 on a selected dose level (RP2D) Day 1 of each cycle Q3W
DB-1303/BNT323
Administered IV
DB-1303/BNT323 Dose Expansion 9
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
DB-1303/BNT323
Administered IV
DB-1303/BNT323 Dose Expansion 10
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
DB-1303/BNT323
Administered IV
Ritonavir
Administered oral
Itraconazole
Administered oral
DB-1303/BNT323 Dose Expansion 11
Enrolled Subjects will receive a single-dose of DB-1303/BNT323 on a selected dose level (RP2D) Day 1 of each cycle Q3W
DB-1303/BNT323
Administered IV
DB-1303/BNT323 Dose Expansion 12
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
DB-1303/BNT323
Administered IV
Pertuzumab Injection
Administered IV
DB-1303/BNT323 Dose Expansion 13
Enrolled Subjects will receive a single-dose of DB-1303/BNT323 on a selected dose level (RP2D) Day 1 of each cycle Q3W
DB-1303/BNT323
Administered IV
DB-1303/BNT323 Dose Expansion 14
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
DB-1303/BNT323
Administered IV
Interventions
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DB-1303/BNT323
Administered IV
Pertuzumab Injection
Administered IV
Ritonavir
Administered oral
Itraconazole
Administered oral
Eligibility Criteria
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Inclusion Criteria
* 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.
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 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.
18 Years
ALL
No
Sponsors
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BioNTech SE
INDUSTRY
DualityBio Inc.
INDUSTRY
Responsible Party
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Locations
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Helios Clinical Research
Cerritos, California, United States
California Research Institute
Los Angeles, California, United States
Sharp Memorial Hospital
San Diego, California, United States
Washington Cancer Institute at MedStar Washington Hospital Center
Washington D.C., District of Columbia, United States
Advanced Research LLC
Coral Springs, Florida, United States
The Oncology Institute of Hope and Innovation
Lakeland, Florida, United States
D&H Cancer Research Center LLC
Margate, Florida, United States
HCA Mercy Hospital
Miami, Florida, United States
BRCR Medical Center Inc.
Plantation, Florida, United States
BRCR Medical Center Inc.
Tamarac, Florida, United States
Southeastern Regional Medical Center, LLC
Newnan, Georgia, United States
Kapi'olani Medical Center for Women and Children
Honolulu, Hawaii, United States
University of Chicago
Chicago, Illinois, United States
Women's Cancer Care
Covington, Louisiana, United States
Holy Cross Hospital
Silver Spring, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Profound Research LLC/Michigan Hematology & Oncology Consultants
Dearborn, Michigan, United States
David C. Pratt Cancer Center
St Louis, Missouri, United States
Women's Cancer Center of Nevada
Las Vegas, Nevada, United States
Northwell Health
Lake Success, New York, United States
Laura & Isaac Perlmutter Cancer Center at NYC Langone Health
New York, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
North Shore Hematology Oncology Associate P.C. DBA New York Cancer and Blood Specialists
Shirley, New York, United States
Regional Medical Oncology Center
Wilson, North Carolina, United States
Gabrail Cancer Center
Canton, Ohio, United States
University of Oklahoma
Oklahoma City, Oklahoma, United States
Rittenhouse Hematology Oncology
Philadelphia, Pennsylvania, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
AHN West Penn Hospital
Pittsburgh, Pennsylvania, United States
Tennessee Oncology
Nashville, Tennessee, United States
Clinical Trial Network
Houston, Texas, United States
Oncology and Hematology of South Texas, PA
Laredo, Texas, United States
NEXT Virginia
Fairfax, Virginia, United States
Swedish Cancer Institute
Seattle, Washington, United States
Scientia Clinical Research LTD
Randwick, New South Wales, Australia
Macquarie Clinical Trials Unit
Sydney, New South Wales, Australia
Integrated Clinical Oncology Network Pty Ltd (Icon)
South Brisbane, Queensland, Australia
Monash Health
Melbourne, Victoria, Australia
The first affiliated hospital of Bengbu medical college
Bengbu, Anhui, China
Anhui provincial hospital
Hefei, Anhui, China
The Second Hospital of Anhui Medical University
Hefei, Anhui, China
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Cancer Hospital Chinese Academy of Medical Science
Beijing, Beijing Municipality, China
The First Hospital of Jilin University
Hongcun, Changchun, China
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, China
The First affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
The First affiliated hospital of Xiamen University
Xiamen, Fujian, China
Gansu Provincial Maternity and Child-care Hospital
Lanzhou, Gansu, China
Huizhou First Hospital
Guangzhou, Guangdong, China
Sun Yat-Sen Memorial Hospital of Zhongshan University
Guangzhou, Guangdong, China
The First affiliated hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
Cancer Hospital of Guangxi Medical University
Nanning, Guangxi, China
The First people's hospital of Yulin
Yulin, Guangxi, China
Affiliated Hospital of Hebei University
Baoding, Hebei, China
Henan cancer Hospital
Zhengzhou, Hehan, China
Anyang Tumor Hospital
Anyang, Henan, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Union hospital Tongji Medical college Huazhong university of science and technology
Wuhan, Hubei, China
Hunan Cancer Hospital
Changsha, Hunan, China
Hunan People's Provincial Hospital
Changsha, Hunan, China
Xiangya Hospital Central South University
Changsha, Hunan, China
Changzhou Tumor Hospital
Changzhou, Jiangsu, China
Affiliated Hospital of Jiangnan University
Wuxi, Jiangsu, China
The Affiliated Hospital of Xuzhou Medical College
Xuzhou, Jiangsu, China
Xuzhou Cancer Hospital
Xuzhou, Jiangsu, China
Jiangxi maternal and child health hospital
Nanchang, Jiangxi, China
The Third Hospital of Nanchang
Nanchang, Jiangxi, China
Jilin Cancer Hospital
Changchun, Jilin, China
Liaoning cancer hospital & Institute
Shenyang, Liaoning, China
The First Hospital of China Medical University
Shenyang, Liaoning, China
The First Affiliated Hospital Of Xi'an Jiaotong University
Xi'an, Shaanxi, China
Central hospital affiliated to Shandong first medical university
Jinan, Shandong, China
Jinan Central Hospital
Jinan, Shandong, China
Shandong Cancer hospital & institute
Jinan, Shandong, China
Affiliated hospital of Jining medical university
Jining, Shandong, China
Linyi Tumor Hospital
Liaocheng, Shandong, China
Zibo Central hospital
Zibo, Shandong, China
Yantai Yuhuangding Hospital
Yantai, Shangdong, China
Fudan University
Shanghai, Shanghai Municipality, China
Shanghai Tenth people's Hospital
Shanghai, Shanghai Municipality, China
The Obstetrics & Gynecology Hospital Affiliated to Fudan University
Shanghai, Shanghai Municipality, China
Tianjin Medical university cancer institute & hospital
Tianjin, Tianjin Municipality, China
Yunnan Provincial Cancer Hospital
Kunming, Yunnan, China
1st affliated hospital of Zhejiang University
Hangzhou, Zhejiang, China
The second affiliated hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Women's hospital school of medicine Zhejiang University
Hangzhou, Zhejiang, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China
BRCR Global Puerto Rico LLC.
Mayagüez, , Puerto Rico
Seoul National University Bundang Hospital
Gyeonggi-do, Bundang-gu, South Korea
Samsung Medical Center
Seoul, Gangnam-gu, South Korea
National Cancer Center
Gyeonggi-do, Ilsandong-gu, South Korea
Severance Hospital
Seoul, Seodaemun-gu, South Korea
Asan Medical Center
Seoul, Songpa-gu, South Korea
Taipei Veterans General Hospital
Taipei, Beitou District, Taiwan
Changhua Christian Hospital
Changhua, Changhua County, Taiwan
Taipei Medical University Hospital
Taipei, Xinyi District, Taiwan
Taipei Medical University-Shuang Ho Hospital
Taipei, Zhonghe District, Taiwan
Mackay Memorial Hospital-Taipei
Taipei, Zhongshan District, Taiwan
National Taiwan University Hospital
Taipei, Zhongzheng District, Taiwan
Kaohsiung Veterans General Hospital
Kaohsiung City, Zuoying District, Taiwan
Countries
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Central Contacts
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Other Identifiers
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DB-1303-O-1001
Identifier Type: -
Identifier Source: org_study_id
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