A Clinical Study to Find the Optimal Dose of an Investigational Treatment Called BNT323 When Used in Combination With Another Investigational Treatment, BNT327, and to Test if That Combination Treatment is Safe and Beneficial for Patients With Advanced Breast Cancer

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

380

Participants

Timeline

Start Date

April 23, 2025

Primary Completion Date

May 31, 2028

Study Completion Date

May 31, 2029

Conditions
Locally Advanced Breast CancerUnresectable Breast CarcinomaMetastatic Breast Cancer
Interventions
DRUG

BNT323

Intravenous infusion

DRUG

BNT327

Intravenous infusion

Trial Locations (10)

2025

RECRUITING

Institute of Oncology Arensia Exploratory Medicine, Chisinau

34952

RECRUITING

Hematology - Oncology Associates of the Treasure Coast, Port Saint Lucie

49546

RECRUITING

START Midwest, LLC, Grand Rapids

78229

RECRUITING

South Texas Accelerated Research Therapeutics (START), LLC, San Antonio

201315

RECRUITING

Fudan University Shanghai Cancer, Shanghai

516003

RECRUITING

Huizhou First Hospital, Huizhou

610072

RECRUITING

Sichuan Cancer Hospital, Chengdu

07932

RECRUITING

Summit Medical Group, Florham Park

0112

RECRUITING

LLC Arensia Exploratory Medicine, Tbilisi

CB2 0QQ

RECRUITING

Addenbrooke s Hospital, Cambridge

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

DualityBio Inc.

INDUSTRY

collaborator

Biotheus Inc.

INDUSTRY

collaborator

BioNTech (Shanghai) Pharmaceuticals Co., Ltd.

UNKNOWN

lead

BioNTech SE

INDUSTRY