Actively Recruiting
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
Led by DualityBio Inc. · Updated on 2026-01-28
796
Participants Needed
102
Research Sites
78 weeks
Total Duration
On this page
Sponsors
D
DualityBio Inc.
Lead Sponsor
B
BioNTech SE
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and tolerability of DB-1303/BNT323 in adults with advanced or metastatic solid tumors that express HER2. This Phase 1/2a trial focuses on patients with tumors that are advanced, unresectable, recurrent, or metastatic and have limited or no standard treatment options. The study aims to identify the best dose and explore early signs of effectiveness in a variety of HER2-expressing cancers. The trial has two parts: an initial dose-escalation phase using an accelerated titration followed by a classic "3+3" design to find the maximum tolerated dose (MTD) or recommended Phase 2 dose (RP2D), and a dose-expansion phase to further assess safety, tolerability, and potential effects at the established dose. Participants receive DB-1303/BNT323 by intravenous infusion once every three weeks (Q3W) at various dose levels. Some groups are randomized to receive different dose levels or combinations with other drugs like Pertuzumab, Ritonavir, or Itraconazole to study drug interactions and responses. During the study, participants will have regular assessments including monitoring for dose-limiting toxicities, adverse events, and serious adverse events using standard criteria up to about one year after treatment. Researchers will also evaluate tumor responses using RECIST 1.1 criteria and collect pharmacokinetic and pharmacodynamic data. Other evaluations include heart function tests, organ function, and overall health status. The study duration varies per participant, with follow-up visits extending up to one year post-treatment to monitor safety and treatment effects.
CONDITIONS
Brief Title
A Phase 1/2a Study of DB-1303/BNT323 in Advanced/Metastatic Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Has a pathologically documented HER2-positive or HER2-expressing (except for cohort 2h where HER2-null is allowed), advanced, unresectable, recurrent, or metastatic malignant solid tumor that is refractory to or intolerable with standard treatment or has no standard treatment available
- At least 1 measurable lesion according to RECIST 1.1
- Signed informed consent provided
- ECOG performance status of 0 or 1
- Left ventricular ejection fraction (LVEF) of 50% or higher by ECHO or MUGA scan
- Adequate organ function
- Provide pre-existing HER2 diagnosis, resected tumor samples, or undergo fresh tumor biopsy for HER2 testing
- Life expectancy of 3 months or more
- Additional for Part 2 Expansion Group 9: advanced/unresectable, recurrent, or metastatic endometrial carcinoma with progression after at least 1 systemic treatment including platinum-based therapy and immune checkpoint inhibitor exposure, with no more than 3 prior lines of therapy for advanced disease; endocrine therapy does not count as systemic therapy
You will not qualify if you...
- History of symptomatic congestive heart failure (NYHA classes II-IV) or serious cardiac arrhythmia needing treatment
- History of myocardial infarction or unstable angina within 6 months before Day 1
- Average QTcF over 450 ms in males or over 470 ms in females
- History of clinically significant lung diseases
- Uncontrolled infection requiring intravenous antibiotics, antivirals, or antifungals
- HIV infection with AIDS-defining illness or active viral hepatitis
- Clinically active brain metastases
- Unresolved toxicities from prior anticancer therapy not improved to grade 1 or baseline according to NCI-CTCAE v5.0
- Known hypersensitivity to the study drug substances or inactive ingredients
- For Part 2 expansion only: multiple primary malignancies within 3 years except for certain adequately treated skin cancers, in-situ diseases, other solid tumors, or contralateral breast cancer
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 3-week cycles until disease progression or discontinuation
Participants receive a single intravenous dose of DB-1303/BNT323 on Day 1 of each 3-week cycle. Some participants may also receive Pertuzumab intravenously or oral Ritonavir or Itraconazole depending on their assigned cohort. Treatment continues in cycles until disease progression or discontinuation.
1 visit per 3-week cycle (in-person)
Duration - Up to approximately 1 year post-treatment
Participants are monitored for safety, tolerability, and antitumor activity after treatment ends, including assessment of adverse events and survival outcomes.
Approximately 1 to 2 visits over 1 year
Trial Site Locations
Total: 102 locations
1
Helios Clinical Research
Cerritos, California, United States, 90703
Active, Not Recruiting
2
California Research Institute
Los Angeles, California, United States, 90027
Active, Not Recruiting
3
Sharp Memorial Hospital
San Diego, California, United States, 92123
Active, Not Recruiting
4
Washington Cancer Institute at MedStar Washington Hospital Center
Washington D.C., District of Columbia, United States, 20010
Active, Not Recruiting
5
Advanced Research LLC
Coral Springs, Florida, United States, 33065
Active, Not Recruiting
6
The Oncology Institute of Hope and Innovation
Lakeland, Florida, United States, 33812
Active, Not Recruiting
7
D&H Cancer Research Center LLC
Margate, Florida, United States, 33063
Active, Not Recruiting
8
HCA Mercy Hospital
Miami, Florida, United States, 33133
Withdrawn
9
BRCR Medical Center Inc.
Plantation, Florida, United States, 33322
Active, Not Recruiting
10
BRCR Medical Center Inc.
Tamarac, Florida, United States, 33321
Active, Not Recruiting
11
Southeastern Regional Medical Center, LLC
Newnan, Georgia, United States, 30265
Active, Not Recruiting
12
Kapi'olani Medical Center for Women and Children
Honolulu, Hawaii, United States, 96826
Active, Not Recruiting
13
University of Chicago
Chicago, Illinois, United States, 60637
Active, Not Recruiting
14
Women's Cancer Care
Covington, Louisiana, United States, 70433
Withdrawn
15
Holy Cross Hospital
Silver Spring, Maryland, United States, 20910
Withdrawn
16
Massachusetts General Hospital
Boston, Massachusetts, United States, 02214
Active, Not Recruiting
17
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Active, Not Recruiting
18
Profound Research LLC/Michigan Hematology & Oncology Consultants
Dearborn, Michigan, United States, 48126
Withdrawn
19
David C. Pratt Cancer Center
St Louis, Missouri, United States, 63141
Active, Not Recruiting
20
Women's Cancer Center of Nevada
Las Vegas, Nevada, United States, 89106
Withdrawn
21
Northwell Health
Lake Success, New York, United States, 11042
Withdrawn
22
Laura & Isaac Perlmutter Cancer Center at NYC Langone Health
New York, New York, United States, 10016
Active, Not Recruiting
23
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Active, Not Recruiting
24
North Shore Hematology Oncology Associate P.C. DBA New York Cancer and Blood Specialists
Shirley, New York, United States, 11967
Active, Not Recruiting
25
Regional Medical Oncology Center
Wilson, North Carolina, United States, 27893
Withdrawn
26
Gabrail Cancer Center
Canton, Ohio, United States, 44718
Active, Not Recruiting
27
University of Oklahoma
Oklahoma City, Oklahoma, United States, 73104
Active, Not Recruiting
28
Rittenhouse Hematology Oncology
Philadelphia, Pennsylvania, United States, 19107
Withdrawn
29
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
Active, Not Recruiting
30
AHN West Penn Hospital
Pittsburgh, Pennsylvania, United States, 15224
Active, Not Recruiting
31
Tennessee Oncology
Nashville, Tennessee, United States, 37203
Active, Not Recruiting
32
Clinical Trial Network
Houston, Texas, United States, 77074
Withdrawn
33
Oncology and Hematology of South Texas, PA
Laredo, Texas, United States, 78041
Active, Not Recruiting
34
NEXT Virginia
Fairfax, Virginia, United States, 22031
Active, Not Recruiting
35
Swedish Cancer Institute
Seattle, Washington, United States, 98104
Active, Not Recruiting
36
Scientia Clinical Research LTD
Randwick, New South Wales, Australia, 2031
Active, Not Recruiting
37
Macquarie Clinical Trials Unit
Sydney, New South Wales, Australia, 2109
Active, Not Recruiting
38
Integrated Clinical Oncology Network Pty Ltd (Icon)
South Brisbane, Queensland, Australia, 4101
Active, Not Recruiting
39
Monash Health
Melbourne, Victoria, Australia, 3168
Active, Not Recruiting
40
The first affiliated hospital of Bengbu medical college
Bengbu, Anhui, China
Actively Recruiting
41
Anhui provincial hospital
Hefei, Anhui, China
Actively Recruiting
42
The Second Hospital of Anhui Medical University
Hefei, Anhui, China
Actively Recruiting
43
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Actively Recruiting
44
Cancer Hospital Chinese Academy of Medical Science
Beijing, Beijing Municipality, China
Actively Recruiting
45
The First Hospital of Jilin University
Hongcun, Changchun, China
Actively Recruiting
46
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, China
Actively Recruiting
47
The First affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
Actively Recruiting
48
The First affiliated hospital of Xiamen University
Xiamen, Fujian, China
Actively Recruiting
49
Gansu Provincial Maternity and Child-care Hospital
Lanzhou, Gansu, China
Actively Recruiting
50
Huizhou First Hospital
Guangzhou, Guangdong, China
Actively Recruiting
51
Sun Yat-Sen Memorial Hospital of Zhongshan University
Guangzhou, Guangdong, China
Actively Recruiting
52
The First affiliated hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
Actively Recruiting
53
Cancer Hospital of Guangxi Medical University
Nanning, Guangxi, China
Actively Recruiting
54
The First people's hospital of Yulin
Yulin, Guangxi, China
Actively Recruiting
55
Affiliated Hospital of Hebei University
Baoding, Hebei, China
Actively Recruiting
56
Henan cancer Hospital
Zhengzhou, Hehan, China
Actively Recruiting
57
Anyang Tumor Hospital
Anyang, Henan, China
Actively Recruiting
58
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Actively Recruiting
59
Union hospital Tongji Medical college Huazhong university of science and technology
Wuhan, Hubei, China
Actively Recruiting
60
Hunan Cancer Hospital
Changsha, Hunan, China
Actively Recruiting
61
Hunan People's Provincial Hospital
Changsha, Hunan, China
Actively Recruiting
62
Xiangya Hospital Central South University
Changsha, Hunan, China
Actively Recruiting
63
Changzhou Tumor Hospital
Changzhou, Jiangsu, China
Withdrawn
64
Affiliated Hospital of Jiangnan University
Wuxi, Jiangsu, China
Actively Recruiting
65
The Affiliated Hospital of Xuzhou Medical College
Xuzhou, Jiangsu, China
Actively Recruiting
66
Xuzhou Cancer Hospital
Xuzhou, Jiangsu, China
Withdrawn
67
Jiangxi maternal and child health hospital
Nanchang, Jiangxi, China
Actively Recruiting
68
The Third Hospital of Nanchang
Nanchang, Jiangxi, China
Actively Recruiting
69
Jilin Cancer Hospital
Changchun, Jilin, China
Actively Recruiting
70
Liaoning cancer hospital & Institute
Shenyang, Liaoning, China
Actively Recruiting
71
The First Hospital of China Medical University
Shenyang, Liaoning, China
Actively Recruiting
72
The First Affiliated Hospital Of Xi'an Jiaotong University
Xi'an, Shaanxi, China
Actively Recruiting
73
Central hospital affiliated to Shandong first medical university
Jinan, Shandong, China
Actively Recruiting
74
Jinan Central Hospital
Jinan, Shandong, China
Actively Recruiting
75
Shandong Cancer hospital & institute
Jinan, Shandong, China
Actively Recruiting
76
Affiliated hospital of Jining medical university
Jining, Shandong, China
Actively Recruiting
77
Linyi Tumor Hospital
Liaocheng, Shandong, China
Actively Recruiting
78
Zibo Central hospital
Zibo, Shandong, China
Actively Recruiting
79
Yantai Yuhuangding Hospital
Yantai, Shangdong, China
Withdrawn
80
Fudan University
Shanghai, Shanghai Municipality, China
Actively Recruiting
81
Shanghai Tenth people's Hospital
Shanghai, Shanghai Municipality, China
Actively Recruiting
82
The Obstetrics & Gynecology Hospital Affiliated to Fudan University
Shanghai, Shanghai Municipality, China
Actively Recruiting
83
Tianjin Medical university cancer institute & hospital
Tianjin, Tianjin Municipality, China
Actively Recruiting
84
Yunnan Provincial Cancer Hospital
Kunming, Yunnan, China
Actively Recruiting
85
1st affliated hospital of Zhejiang University
Hangzhou, Zhejiang, China
Actively Recruiting
86
The second affiliated hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Actively Recruiting
87
Women's hospital school of medicine Zhejiang University
Hangzhou, Zhejiang, China
Actively Recruiting
88
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
Actively Recruiting
89
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China
Withdrawn
90
BRCR Global Puerto Rico LLC.
Mayagüez, Puerto Rico, 00682
Withdrawn
91
Seoul National University Bundang Hospital
Gyeonggi-do, Bundang-gu, South Korea, 13620
Active, Not Recruiting
92
Samsung Medical Center
Seoul, Gangnam-gu, South Korea, 06351
Active, Not Recruiting
93
National Cancer Center
Gyeonggi-do, Ilsandong-gu, South Korea, 10408
Active, Not Recruiting
94
Severance Hospital
Seoul, Seodaemun-gu, South Korea, 03722
Active, Not Recruiting
95
Asan Medical Center
Seoul, Songpa-gu, South Korea, 05505
Active, Not Recruiting
96
Taipei Veterans General Hospital
Taipei, Beitou District, Taiwan, 11217
Active, Not Recruiting
97
Changhua Christian Hospital
Changhua, Changhua County, Taiwan, 50006
Active, Not Recruiting
98
Taipei Medical University Hospital
Taipei, Xinyi District, Taiwan, 110301
Active, Not Recruiting
99
Taipei Medical University-Shuang Ho Hospital
Taipei, Zhonghe District, Taiwan, 235041
Active, Not Recruiting
100
Mackay Memorial Hospital-Taipei
Taipei, Zhongshan District, Taiwan, 10449
Active, Not Recruiting
101
National Taiwan University Hospital
Taipei, Zhongzheng District, Taiwan, 100225
Active, Not Recruiting
102
Kaohsiung Veterans General Hospital
Kaohsiung City, Zuoying District, Taiwan, 81362
Active, Not Recruiting
Research Team
B
Britney Winterberger
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
24
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