BNT323

DRUG3 trials

Sponsors

BioNTech SE

Conditions

Advanced Breast Cancer Metastatic Breast CancerEndometrial cancerLocally Advanced Breast CancerMetastatic Breast CancerUnresectable Breast Carcinoma

Phase 1

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

RecruitingNCT06827236

BioNTech SELocally Advanced Breast Cancer, Metastatic Breast Cancer, Unresectable Breast Carcinoma

Start: 2025-04-23End: 2029-05-01Target: 380Updated: 2026-03-20

A Phase I/II, multi-site, open-label, two-part trial to evaluate the efficacy, safety, and pharmacokinetics of BNT323 in combination with BNT327 in participants with advanced breast cancer

Not yet recruitingCTIS2024-517979-20-00

BioNTech SEAdvanced Breast Cancer Metastatic Breast Cancer

Target: 95Updated: 2025-11-17

Phase 3

A Phase III, randomized, multi-site, open-label trial of BNT323/DB-1303 versus investigator’s choice of chemotherapy in previously treated patients with HER2- expressing recurrent endometrial cancer

RecruitingCTIS2023-507525-42-00

BioNTech SEEndometrial cancer

Start: 2025-12-23Target: 222Updated: 2025-11-17