A Study to Compare DB-1303/BNT323 Versus T-DM1 in Breast Cancer

HER2-positive Breast Cancer Clinical Trial

Official title:

A Phase III, Multicenter, Open-label, Randomized Study to Compare DB-1303 Versus T-DM1 in Patients With HER2-positive Unresectable/Metastatic Breast Cancer Who Have Been Treated With Trastuzumab and a Taxane (Dynasty-Breast01)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06265428
• Other study ID #: DB-1303-O-3001
• Secondary ID: CTR20233403
• Status: Recruiting
• Phase: Phase 3
• Start date: January 29, 2024
• Est. completion date: February 2026

Study information

• Verified date: February 2024
• Source: DualityBio Inc.
• Contact: Ren Yue
• Phone: +862126018730
• Email: ren.yue[@]dualitybiologics.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 224
• Est. completion date: February 2026
• Est. primary completion date: February 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Breast Neoplasms
• HER2-positive Breast Cancer

Intervention

Drug:
• DB-1303/BNT323
Administered I.V.
• T-DM1
Administered I.V.

Locations

Country	Name	City	State
China	The Fifth Medical Center of the Chinese People's Liberation Army General Hospital	Beijing	Beijing
China	Fudan University Shanghai Cancer Center	Shanghai	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
DualityBio Inc.	BioNTech SE

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression Free Survival (PFS) by Blinded Independent Central Review (BICR) assessment per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)	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	Up to approximately 24 months.
Secondary	Overall Survival (OS)	Defined as the time from randomization to death due to any cause.	Up to approximately 24 months.
Secondary	Progression Free Survival (PFS) by Investigator assessment per RECIST 1.1	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.	Up to approximately 24 months.
Secondary	Objective response rate (ORR) by BICR and investigator assessment per RECIST 1.1	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.	Up to approximately 24 months.
Secondary	Duration of response (DoR) by BICR and investigator assessment per RECIST 1.1	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.	Up to approximately 24 months.
Secondary	PK parameters: maximum observed concentration (Cmax)	Maximum observed concentration (Cmax) of DB-1303/BNT323 Antibody-drug conjugate (ADC) and free toxin P1003, etc. after DB-1303/BNT323 administration	Up to approximately 24 months.
Secondary	PK parameters: time to maximum concentration (Tmax)	Time to maximum concentration (Tmax) of DB-1303/BNT323 ADC and free toxin P1003, etc. after DB-1303/BNT323 administration	Up to approximately 24 months.
Secondary	Adverse events (AEs)	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])	Up to approximately 24 months.
Secondary	Patient reported outcomes (PROs): European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) - C30	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.	Up to approximately 24 months.
Secondary	Patient reported outcomes (PROs): EORTC QLQ-BR45	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.	Up to approximately 24 months.
Secondary	Patient reported outcomes (PROs): European Quality of Life Five Dimension Five Level Scale (EQ-5D-5L)	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.	Up to approximately 24 months.
Secondary	European Quality of Life Five Dimension Five Level Scale (EQ-5D-5L)	EQ-5D-5L health state utility index score and Visual Analogue Scale (VAS) score. The change from baseline value will be reported.	Up to approximately 24 months.
Secondary	Anti-drug antibodies (ADA)	Number and percentage of patients who develop anti-drug antibody (ADA) for DB-1303/BNT323.	Up to approximately 24 months.