Trial intelligence / Profile preview

ROSETTA Breast-01

2025-521884-12-00Phase 3Authorised

Sponsor
BioNTech SE
Start
Mar 2026
Modality
Bispecific Antibodies → Multispecific Antibodies → Engineered Antibody Formats → Antibody-Based Therapeutics
Countries
20
01

Overview

Phase 3, randomised, double-blind trial in triple-negative breast cancer (TNBC) and breast cancer comparing Pumitamig + chemotherapy with Placebo + chemotherapy (2 arms). Primary endpoints: Overall survival and Progression-free survival by BICR. Planned start Mar 2026; status: authorised.

02

Drugs

pumitamig
03

Conditions

triple-negative breast cancer (TNBC)breast cancer

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Available in the Gosset platform where reported.

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