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RECRUITING Phase 1 / Phase 2 ClinicalTrials.gov

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

Sponsor: BioNTech SE • ClinicalTrials.gov ID: NCT06827236

Registry updated: 2026-10-15
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Description

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).

Interventions

  • BNT323 (Drug)
    Intravenous infusion
  • BNT327 (Drug)
    Intravenous infusion

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 to study screening (Part 1, Part 2 Cohorts 2 and 4) or the central laboratory (Part 2, Cohorts 1 and 3) from the most recently collected pre-randomization tumor sample. * Has a documented history of HER2 expression consistent with the subgroup definitions (i.e., HER2-low, HER2-ultralow, HER2-null, HER2-positive, or TNBC) as per current American Society of Clinical Oncology/College of American Pathologists guidelines. * Have measurable disease defined by RECIST v1.1. * Has left ventricular ejection fraction ≥55% by either echocardiography or multi-gated acquisition (scanning) within 28 days before randomization/enrollment. Key Exclusion Criteria: * Have history of small bowel obstruction requiring hospitalization within the past 3 months prior to the first dose of IMP. * Have an uncontrolled intercurrent illness that would limit compliance with study requirement or substantially increase risk of incurring adverse events. * Have clinically uncontrolled pleural effusion, ascites or pericardial effusion requiring drainage, peritoneal shunt, or cell-free concentrated ascites reinfusion therapy within 2 weeks prior to randomization/enrollment. * Have a history of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required steroids, have current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening. * Had prior treatment with topoisomerase I inhibitors, including antibody-drug conjugates with topoisomerase I inhibitor payloads such as trastuzumab deruxtecan. * Have received any of the following therapies or drugs prior to the initiation of the study: * Participants who have received prior treatment with BNT323. * Participants who received prior treatment with a programmed death-ligand 1 (PD-L1) / vascular endothelial growth factor (VEGF) bispecific antibody. Note: Prior treatment with programmed death 1 (PD-1)/VEGF bispecific antibodies, PD-1/PD-L1 inhibitors or anti-VEGF therapies are permitted. * Have received other systemic immunostimulatory agents or immunosuppressive therapies (such as interferon-α, interleukin-2, or methotrexate) within 4 weeks prior to the initiation of study treatment or are within five half-lives of the treatment drug (whichever is longer). Exception: excluding local, intranasal, intraocular, intra-articular or inhaled corticosteroids, short term use (≤7 days) of corticosteroids for prophylaxis (e.g., prevention of contrast agent allergy) or treatment of non-autoimmune conditions (e.g., delayed hypersensitivity reactions caused by exposure to allergens). * Have received systemic corticosteroids (at a dosage greater than 10 mg/day of prednisone or an equivalent dose of other corticosteroids) within 3 weeks prior to the initiation of study treatment. NOTE: Other protocol defined Inclusion/Exclusion criteria apply.

Conditions

Locally Advanced Breast Cancer Unresectable Breast Carcinoma Metastatic Breast Cancer

Locations

  • Beverly Hills Cancer Center — Beverly Hills, California, United States
  • Hoag Memorial Hospital Presbyterian — Newport Beach, California, United States
  • Hematology - Oncology Associates of the Treasure Coast — Port Saint Lucie, Florida, United States
  • University Cancer & Blood Center, LLC — Athens, Georgia, United States
  • Winship Cancer Institute of Emory University — Atlanta, Georgia, United States
  • University of Illinois Hospital & Health Sciences System — Chicago, Illinois, United States
  • Karmanos Cancer Institute — Detroit, Michigan, United States
  • Brigitte Harris Cancer Pavilion BHCP — Detroit, Michigan, United States
  • START Midwest, LLC — Grand Rapids, Michigan, United States
  • Saint Luke's Hospital of Kansas City — Kansas City, Missouri, United States
  • Washington University School of Medicine — St Louis, Missouri, United States
  • Memorial Sloan Kettering Cancer Center Basking Ridge — Basking Ridge, New Jersey, United States
  • Summit Medical Group — Florham Park, New Jersey, United States
  • Memorial Sloan Kettering Cancer Center Monmouth — Middletown, New Jersey, United States
  • Memorial Sloan Kettering Cancer Center Bergen — Montvale, New Jersey, United States
  • Memorial Sloan Kettering Cancer Center Westchester — Harrison, New York, United States
  • Beth Israel Comprehensive Cancer Center — New York, New York, United States
  • Mount Sinai Medical Center — New York, New York, United States
  • Icahn School of Medicine at Mount Sinai PRIME — New York, New York, United States
  • Memorial Sloan Kettering Hospital — New York, New York, United States
  • Memorial Sloan Kettering Commack — New York, New York, United States
  • Stony Brook University Hospital — Stony Brook, New York, United States
  • Memorial Sloan Kettering Cancer Center Nassau — Uniondale, New York, United States
  • Greco Hainsworth Center for Research Tennessee Oncology — Nashville, Tennessee, United States
  • SCRI Oncology Partners — Nashville, Tennessee, United States
  • Baylor Scott & White Research Institute -Texas Oncology — Dallas, Texas, United States
  • UT Southwestern Medical Center — Dallas, Texas, United States
  • South Texas Accelerated Research Therapeutics (START), LLC — San Antonio, Texas, United States
  • Cancer Research SA — Adelaide, Australia
  • Box Hill Hospital — Box Hill, Australia
  • St Vincent s Hospital Melbourne — Fitzroy, Australia
  • Peter MacCallum Cancer Centre — Melbourne, Australia
  • CIUSSS du Saguenay-Lac-Saint-Jean — Chicoutimi, Canada
  • London Health Sciences Centre (LHSC) - Victoria Hospital — London, Canada
  • Sunnybrook Health Sciences Centre — Toronto, Canada
  • BC Cancer - Vancouver — Vancouver, Canada
  • The First Affiliated Hospital of Bengbu Medical College — Bengbu, China
  • Jilin Cancer Hospital — Changchun, China
  • Sichuan Cancer Hospital — Chengdu, China
  • Sichuan Provincial People's Hospital — Chengdu, China
  • The First Affiliated Hospital of Chongqing Medical University — Chongqing, China
  • Huizhou First Hospital — Huizhou, China
  • Guangxi Medical University Affiliated Tumor Hospital — Nanning, China
  • Fudan University Shanghai Cancer — Shanghai, China
  • The Second Affiliated Hospital of Xi an Jiaotong University — Xi'an, China
  • CHU Besançon - Hôpital Jean Minjoz — Besançon, France
  • Clinique Victor Hugo - Centre Jean Bernard — Le Mans, France
  • ICO - Site René Gauducheau — Saint-Herblain, France
  • Institut Claudius Regaud — Toulouse, France
  • LLC Arensia Exploratory Medicine — Tbilisi, Georgia
  • Azienda Ospedaliera Universitaria Policlinico Sant Orsola Malpighi IRCCS — Bologna, Italy
  • Istituto Nazionale per la Ricerca sul Cancro di Genova — Genova, Italy
  • IEO Istituto Europeo di Oncologia — Milan, Italy
  • Istituto Nazionale Tumori Fondazione G. Pascale — Naples, Italy
  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS — Roma, Italy
  • Institute of Oncology Arensia Exploratory Medicine — Chisinau, Moldova
  • Hospital HM Nou Delfos — Barcelona, Spain
  • NEXT Barcelona — Barcelona, Spain
  • Hospital Universitari Dexeus — Barcelona, Spain
  • Hospital Clinic de Barcelona — Barcelona, Spain
  • MD Anderson Cancer Centre — Madrid, Spain
  • Centro Integral Oncologico Clara Campal — Madrid, Spain
  • NEXT Madrid — Pozuelo de Alarcón, Spain
  • Medical Park Seyhan Hospital — Adana, Turkey (Türkiye)
  • Adana City Hospital — Adana, Turkey (Türkiye)
  • Hacettepe University Medical Faculty — Ankara, Turkey (Türkiye)
  • Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital — Ankara, Turkey (Türkiye)
  • Ankara City Hospital — Ankara, Turkey (Türkiye)
  • Yeditepe Universitesi Kosuyolu Hastanesi — Istanbul, Turkey (Türkiye)
  • Koc University Hospital — Istanbul, Turkey (Türkiye)
  • IAU Medical Park Florya Hospital — Istanbul, Turkey (Türkiye)
  • Ege University Medical Faculty — Izmir, Turkey (Türkiye)
  • Konya Necmettin Erbakan University Meram Medical Faculty — Konya, Turkey (Türkiye)
  • Mersin City Education and Research Hospital — Mersin, Turkey (Türkiye)
  • Addenbrooke s Hospital — Cambridge, United Kingdom
  • Velindre Cancer Centre — Cardiff, United Kingdom
  • St James's University Hospital — Leeds, United Kingdom
  • Royal Free Hospital — London, United Kingdom
  • Royal Marsden Hospital — London, United Kingdom
  • The Christie Hospital — Manchester, United Kingdom
  • Royal Marsden Hospital-Sutton — Sutton, United Kingdom
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record