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
Recruiting
Phase 1
Phase 2
Interventional Study
Locally Advanced Breast Cancer
Unresectable Breast Carcinoma
Metastatic Breast Cancer
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 1/2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 380 (estimated)
- Sponsor
- BioNTech SE · Industry
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About This Trial
This is a Phase I/II, multi-site, open-label, two-part study designed to evaluate the efficacy, safety, optimized dose and contribution of components of BNT323 (also known as trastuzumab pamirtecan and DB-1303) in combination with BNT327 (also known as pumitamig and PM8002) in participants with hormone receptor-positive (HR+) or hormone receptor-negative (HR-), Human epidermal growth factor recept…
Trial Locations
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Eligibility Criteria
Key Inclusion Criteria (applicable to all participants and all parts unless otherwise specified):
* Have pathologically documented BC that:
* Is locally advanced, unresectable or metastatic.
* Has a confirmed HER2 status as determined by the local laboratory as standard of care testing prior t…
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