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Clinical Trials in the UK / NCT06827236
Recruiting Phase 1/2

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

NCT06827236 · tracked via the Priya Life Science UK tracker
Sponsor
BioNTech SE
Phase
Phase 1/2
Started
2025-04-23
Last updated
2026-09-17

Condition(s) studied

Locally Advanced Breast CancerUnresectable Breast CarcinomaMetastatic Breast Cancer

Investigational drug(s) / intervention(s)

BNT323BNT327

BNT323: Intravenous infusion

BNT327: Intravenous infusion

Study summary

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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (79)

FacilityCityRegionStatus
Beverly Hills Cancer Center Beverly Hills California Recruiting
Hoag Memorial Hospital Presbyterian Newport Beach California Recruiting
Hematology - Oncology Associates of the Treasure Coast Port Saint Lucie Florida Recruiting
University Cancer & Blood Center, LLC Athens Georgia Recruiting
Winship Cancer Institute of Emory University Atlanta Georgia Recruiting
University of Illinois Hospital & Health Sciences System Chicago Illinois Recruiting
Karmanos Cancer Institute Detroit Michigan Recruiting
Brigitte Harris Cancer Pavilion BHCP Detroit Michigan Recruiting
START Midwest, LLC Grand Rapids Michigan Recruiting
Saint Luke's Hospital of Kansas City Kansas City Missouri Recruiting
Washington University School of Medicine St Louis Missouri Recruiting
Memorial Sloan Kettering Cancer Center Basking Ridge Basking Ridge New Jersey Recruiting
Summit Medical Group Florham Park New Jersey Recruiting
Memorial Sloan Kettering Cancer Center Monmouth Middletown New Jersey Recruiting
Memorial Sloan Kettering Cancer Center Bergen Montvale New Jersey Recruiting
Memorial Sloan Kettering Cancer Center Westchester Harrison New York Recruiting
Beth Israel Comprehensive Cancer Center New York New York Recruiting
Mount Sinai Medical Center New York New York Recruiting
Icahn School of Medicine at Mount Sinai PRIME New York New York Recruiting
Memorial Sloan Kettering Hospital New York New York Recruiting
Memorial Sloan Kettering Commack New York New York Recruiting
Stony Brook University Hospital Stony Brook New York Recruiting
Memorial Sloan Kettering Cancer Center Nassau Uniondale New York Recruiting
SCRI Oncology Partners Nashville Tennessee Recruiting
Baylor Scott & White Research Institute -Texas Oncology Dallas Texas Recruiting
UT Southwestern Medical Center Dallas Texas Recruiting
South Texas Accelerated Research Therapeutics (START), LLC San Antonio Texas Recruiting
Cancer Research SA Adelaide Australia Recruiting
Box Hill Hospital Box Hill Australia Recruiting
St Vincent s Hospital Melbourne Fitzroy Australia Recruiting
CIUSSS du Saguenay-Lac-Saint-Jean Chicoutimi Canada Recruiting
London Health Sciences Centre (LHSC) - Victoria Hospital London Canada Recruiting
Sunnybrook Health Sciences Centre Toronto Canada Recruiting
BC Cancer - Vancouver Vancouver Canada Recruiting
The First Affiliated Hospital of Bengbu Medical College Bengbu China Recruiting
Jilin Cancer Hospital Changchun China Recruiting
Sichuan Cancer Hospital Chengdu China Recruiting
Sichuan Provincial People's Hospital Chengdu China Recruiting
The First Affiliated Hospital of Chongqing Medical University Chongqing China Recruiting
Huizhou First Hospital Huizhou China Recruiting

+ 39 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06827236 on ClinicalTrials.gov ↗ ← All trials in the UK