A Study to Compare DB-1303/BNT323 Versus T-DM1 in Breast Cancer
NCT ID: NCT06265428
Last Updated: 2025-10-17
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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ACTIVE_NOT_RECRUITING
PHASE3
228 participants
INTERVENTIONAL
2024-01-29
2026-02-28
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
Enrolled patients will receive DB-1303/BNT323 by intravenous (I.V.) infusion
DB-1303/BNT323
Administered I.V.
T-DM1
Enrolled patients will receive T-DM1 by I.V. infusion
T-DM1
Administered I.V.
Interventions
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DB-1303/BNT323
Administered I.V.
T-DM1
Administered I.V.
Eligibility Criteria
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Inclusion Criteria
* Pathologically confirmed unresectable or metastatic HER2 positive breast cancer previously treated with trastuzumab and taxane
* Eastern Cooperative Oncology Group (ECOG) performance status score is 0 or 1.
* Presence of at least one measurable lesion according to RECIST v1.1
* Expected survival time ≥ 12 weeks.
* Patients must give informed consent to this study and voluntarily sign written informed consent form prior to the study.
Exclusion Criteria
* Previous history of interstitial lung disease/noninfectious pneumonitis/radiation pneumonitis requiring steroid therapy.
* Known serious hypersensitivity to the active ingredients of the study drug, inactive ingredients in the formulation, or other antibody drugs.
* Multiple primary malignancies within 3 years, except for adequately resected non-melanoma skin cancer, curatively treated in situ tumor, or contralateral breast cancer
* Uncontrolled infection requiring intravenous antibiotics, antiviral or antifungal agents, autoimmune disease requiring treatment, uncontrolled diabetes, hypertension, or other systemic disease that makes compliance with study procedures difficult
* Unrecovered toxicity from prior anticancer therapy, defined as toxicity (except for alopecia) not recovered to ≤Grade 1 (NCI-CTCAE v5.0) or baseline.
18 Years
ALL
No
Sponsors
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BioNTech SE
INDUSTRY
DualityBio Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Lily Hu
Role: STUDY_DIRECTOR
DualityBio Inc.
Locations
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015
Bengbu, Anhui, China
016
Hefei, Anhui, China
029
Hefei, Anhui, China
001
Beijing, Beijing Municipality, China
010
Beijing, Beijing Municipality, China
038
Jilin, Changchun, China
036
Fuzhou, Fujian, China
037
Xiamen, Fujian, China
023
Guangzhou, Guangdong, China
024
Guangzhou, Guangdong, China
026
Guangzhou, Guangdong, China
028
Huizhou, Guangdong, China
017
Nanning, Guangxi, China
022
Nanning, Guangxi, China
043
Haikou, Hainan, China
045
Baoding, Hebei, China
048
Shijiazhuang, Hebei, China
020
Haerbin, Heilongjiang, China
018
Luoyang, Henan, China
006
Zhengzhou, Henan, China
005
Zhengzhou, Henan, China
011
Wuhan, Hubei, China
009
Wuhan, Hubei, China
030
Changsha, Hunan, China
027
Nanjing, Jiangsu, China
004
Nanjing, Jiangsu, China
044
Xuzhou, Jiangsu, China
014
Nanchang, Jiangxi, China
008
Changchun, Jilin, China
032
Dalian, Liaoning, China
040
Binzhou, Shandong, China
031
Jinan, Shandong, China
047
Jinan, Shandong, China
012
Linyi, Shandong, China
039
Yantai, Shandong, China
002
Shanghai, Shanghai Municipality, China
046
Shanghai, Shanghai Municipality, China
035
Taiyuan, Shanxi, China
003
Xi’an, Shanxi, China
007
Chengdu, Sichuan, China
041
Neijiang, Sichuan, China
034
Yibin, Sichuan, China
021
Tianjin, Tianjin Municipality, China
013
Ürümqi, Xinjiang, China
033
Kunming, Yunnan, China
019
Hangzhou, Zhejaing, China
025
Hangzhou, Zhejiang, China
042
Hangzhou, Zhejiang, China
Countries
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Other Identifiers
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CTR20233403
Identifier Type: OTHER
Identifier Source: secondary_id
DB-1303-O-3001
Identifier Type: -
Identifier Source: org_study_id
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