OncoMatch/Clinical Trials/NCT06827236
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
Is NCT06827236 recruiting? Yes, currently enrolling (Sep 2026). This Phase 1/2 trial studies multiple treatments including BNT323 and BNT327 for locally advanced breast cancer.
Treatment: BNT323 · BNT327 — 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 receptor (HER)2-positive, HER2-low (immunohistochemistry \[IHC\] 1+ or IHC 2+/in situ hybridization -), HER2-ultralow (IHC 0, with membrane staining) or HER2-null breast cancer (BC), or triple-negative breast cancer (TNBC).
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Breast Carcinoma
Prior therapy
Cannot have received: topoisomerase i inhibitor
Cannot have received: antibody-drug conjugate with topoisomerase i inhibitor payload (trastuzumab deruxtecan)
Cannot have received: bnt323 (bnt323)
Cannot have received: pd-l1/vegf bispecific antibody
Exception: prior treatment with pd-1/vegf bispecific antibodies, pd-1/pd-l1 inhibitors or anti-vegf therapies are permitted.
Lab requirements
Cardiac function
left ventricular ejection fraction ≥55% by either echocardiography or multi-gated acquisition (scanning) within 28 days before randomization/enrollment
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Beverly Hills Cancer Center · Beverly Hills, California
- Hoag Memorial Hospital Presbyterian · Newport Beach, California
- Hematology - Oncology Associates of the Treasure Coast · Port Saint Lucie, Florida
- University Cancer & Blood Center, LLC · Athens, Georgia
- Winship Cancer Institute of Emory University · Atlanta, Georgia
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT06827236 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior topoisomerase i inhibitor, antibody-drug conjugate with topoisomerase i inhibitor payload, bnt323 disqualifies patients from enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages