A Study to Compare DB-1303/BNT323 Versus T-DM1 in Breast Cancer
- Registration Number
- NCT06265428
- Lead Sponsor
- DualityBio Inc.
- Brief Summary
This study is designed to compare efficacy and safety of DB-1303/BNT323 versus T-DM1 in HER2-positive, unresectable and/or metastatic breast cancer patients previously treated with trastuzumab and taxane.
- Detailed Description
This is a randomized controlled, 2-arm, open-label, multicenter phase III study to assess the efficacy and safety of DB-1303/BNT323 versus Trastuzumab Emtansine (T-DM1) in patients with human epidermal growth factor receptor 2 (HER2) -positive unresectable/metastatic breast cancer who have been treated with trastuzumab and taxanes. Approximately 224 patients with unresectable or metastatic HER2-positive breast cancer will be randomized 1:1 to receive DB-1303/BNT323 or T-DM1, respectively.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 224
- Male or female adults ≥ 18 years at the time of voluntary signing of informed consent.
- 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.
- Prior anti-HER2 ADC therapy.
- 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.
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description DB-1303/BNT323 DB-1303/BNT323 Enrolled patients will receive DB-1303/BNT323 by intravenous (I.V.) infusion T-DM1 T-DM1 Enrolled patients will receive T-DM1 by I.V. infusion
- Primary Outcome Measures
Name Time Method Progression Free Survival (PFS) by Blinded Independent Central Review (BICR) assessment per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Up to approximately 24 months. Defined as the time from randomization to the first documented disease progression per RECIST 1.1 as assessed by BICR or death due to any cause, whichever occurs first
- Secondary Outcome Measures
Name Time Method Progression Free Survival (PFS) by Investigator assessment per RECIST 1.1 Up to approximately 24 months. Defined as the time from randomization to the first documented disease progression per RECIST 1.1 as assessed by investigator or death due to any cause, whichever occurs first.
PK parameters: maximum observed concentration (Cmax) Up to approximately 24 months. Maximum observed concentration (Cmax) of DB-1303/BNT323 Antibody-drug conjugate (ADC) and free toxin P1003, etc. after DB-1303/BNT323 administration
Overall Survival (OS) Up to approximately 24 months. Defined as the time from randomization to death due to any cause.
Objective response rate (ORR) by BICR and investigator assessment per RECIST 1.1 Up to approximately 24 months. Defined as the percentage of patients who have a complete response (CR) or partial response (PR) per RECIST 1.1 as assessed by BICR and investigator assessment.
Adverse events (AEs) Up to approximately 24 months. Number and percentage of patients who report serious adverse events (SAEs), treatment-emergent adverse events (TEAEs), TEAEs leading to study drug discontinuation, adverse events of special interest (AESIs) (graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0\[NCI-CTCAE v5.0\])
Patient reported outcomes (PROs): EORTC QLQ-BR45 Up to approximately 24 months. Change from baseline in the functioning/symptom subscales of EORTC QLQ-BR45. Scale scores range from 0-100. For functioning scales, higher scores indicate better functioning. For symptom scales, higher scores indicate greater symptom burden.
Duration of response (DoR) by BICR and investigator assessment per RECIST 1.1 Up to approximately 24 months. Defined as the time from first response (CR or PR) to subsequent disease progression per RECIST 1.1 as assessed by BICR and investigator assessment, or death from any cause, whichever occurs first.
PK parameters: time to maximum concentration (Tmax) Up to approximately 24 months. Time to maximum concentration (Tmax) of DB-1303/BNT323 ADC and free toxin P1003, etc. after DB-1303/BNT323 administration
Patient reported outcomes (PROs): European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) - C30 Up to approximately 24 months. Change from baseline in the functioning/symptom/global quality of life (QoL) subscales of EORTC QLQ-C30. Scale scores range from 0-100. For functioning and global QoL scales, higher scores indicate better functioning or global health status. For symptom scales, higher scores indicate greater symptom burden.
Patient reported outcomes (PROs): European Quality of Life Five Dimension Five Level Scale (EQ-5D-5L) Up to approximately 24 months. Change from baseline in EQ-5D-5L health state utility index score and Visual Analogue Scale (VAS) score. VAS score range from 0-100, higher scores indicate better health status.
European Quality of Life Five Dimension Five Level Scale (EQ-5D-5L) Up to approximately 24 months. EQ-5D-5L health state utility index score and Visual Analogue Scale (VAS) score. The change from baseline value will be reported.
Anti-drug antibodies (ADA) Up to approximately 24 months. Number and percentage of patients who develop anti-drug antibody (ADA) for DB-1303/BNT323.
Trial Locations
- Locations (48)
015
🇨🇳Bengbu, Anhui, China
029
🇨🇳Hefei, Anhui, China
001
🇨🇳Beijing, Beijing, China
010
🇨🇳Beijing, Beijing, China
038
🇨🇳Jilin, Changchun, China
037
🇨🇳Xiamen, Fujian, China
048
🇨🇳Shijiazhuang, Hebei, China
020
🇨🇳Haerbin, Heilongjiang, China
016
🇨🇳Hefei, Anhui, China
036
🇨🇳Fuzhou, 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
005
🇨🇳Zhengzhou, Henan, China
043
🇨🇳Haikou, Hainan, China
045
🇨🇳Baoding, Hebei, China
011
🇨🇳Wuhan, Hubei, China
018
🇨🇳Luoyang, Henan, China
006
🇨🇳Zhengzhou, Henan, 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, China
046
🇨🇳Shanghai, Shanghai, 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, China
013
🇨🇳Ürümqi, Xinjiang, China
033
🇨🇳Kunming, Yunnan, China
019
🇨🇳Hangzhou, Zhejaing, China
025
🇨🇳Hangzhou, Zhejiang, China
042
🇨🇳Hangzhou, Zhejiang, China