> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-clinical-study-to-find-the-optimal-dose-of-an-a8403450-53b2-427f-b00a-eeee649d5f57 > Record changed: 2026-11-04 # 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06827236) Phase Phase 1/Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06827236) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06827236) Participants 380 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06827236) Lead sponsor BioNTech SE Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06827236) Start date 2025-04-23 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06827236) Number of sites 81 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06827236) ## Title and summary **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). Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06827236) **Short title** 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06827236) **Official title** A Phase I/II, Multi-site, Open-label, Two-part Trial to Evaluate the Efficacy, Safety, and Pharmacokinetics of BNT323 in Combination With BNT327 in Participants With Advanced Breast Cancer Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06827236) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06827236) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06827236) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06827236) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06827236) **Phase** Phase 1/Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06827236) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06827236) ## Dates **Completion date** 2029-08-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06827236) **First posted** 2025-02-14 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06827236) **Registry last updated** 2026-10-15 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06827236) **Primary completion date** 2029-08-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06827236) **Start date** 2025-04-23 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06827236) ## Size and sites **Participants** 380 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06827236) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06827236) **Planned participants** 380 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06827236) **Protocol amendments** 4 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06827236) **Randomisation ratio** 2:2:1:1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06827236) **Number of sites** 81 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06827236) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06827236) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06827236) **Lead sponsor** BioNTech SE Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06827236) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06827236) ## Identifiers **Registry ID** NCT06827236 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06827236) **ClinicalTrials.gov ID** NCT06827236 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06827236) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06827236) ## Study design **Allocation** Randomised **Model** Sequential **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06827236) ## Outcomes ### Primary outcomes 1. Part 1 - Occurrence of dose limiting toxicities (DLTs) Timeframe: During the DLT evaluation period (Cycle 1), i.e., the time of initiation of the first dose of investigational medicinal product (IMP) up to 21 days By dose level. 2. Occurrence of Treatment-emergent adverse events (TEAEs), Grade ≥3 TEAEs, serious adverse events (SAEs), treatment-related TEAEs, treatment-related Grade ≥3 TEAEs, and treatment-related SAEs Timeframe: From the time of initiation of the first dose of IMP to 90 days after the last IMP dose In Part 1 by dose level. In Part 2 by cohort and arm. 3. Occurrence of dose interruption, reduction, and discontinuation due to TEAEs Timeframe: From the time of initiation of the first dose of IMP to 90 days after the last IMP dose In Part 1 by dose level. In Part 2 by cohort and arm. 4. Part 2 - Objective response rate (ORR) Timeframe: From the time of initiation of the first dose of IMP to last tumor assessment scan, i.e., up to 36 months. ORR defined as the proportion of participants in whom a confirmed complete response (CR) or partial response (PR) (per Response Evaluation Criteria in Solid Tumors version 1.1 \\\[RECIST v1.1\\\] based on the investigator's assessment) is observed as best overall response. By cohort and arm. ### Secondary outcomes 1. Part 1 - ORR Timeframe: From the time of initiation of the first dose of IMP to last tumor assessment scan, i.e., up to 36 months. ORR defined as the proportion of participants in whom a confirmed CR or PR (per RECIST v1.1 based on the investigator's assessment) is observed as best overall response. By dose level. 2. Part 2 - Duration of response (DoR) Timeframe: From the time of initiation of the first dose of IMP to last tumor assessment scan, i.e., up to 36 months. DoR defined as the time from first objective response (CR or PR per RECIST v1.1 based on the investigator's assessment) to first occurrence of objective tumor progression (progressive disease \\\[PD\\\], per RECIST v1.1 based on the investigator's assessment) or death from any cause, whichever occurs first. By cohort and arm. 3. Part 2 - Disease control rate (DCR) Timeframe: From the time of initiation of the first dose of IMP to last tumor assessment scan, i.e., up to 36 months. DCR defined as the proportion of participants with confirmed CR, PR, or stable disease (per RECIST v1.1 based on the investigator's assessment) as best overall response. By cohort and arm. 4. Part 2 - Time to response (TTR) Timeframe: From the time of initiation of the first dose of IMP to last tumor assessment scan, i.e., up to 36 months. TTR defined as the time from first dose of IMP to first objective response (CR or PR per RECIST v1.1 based on the investigator's assessment). By cohort and arm. 5. Part 2 Cohort 1 only - Progression free survival (PFS) Timeframe: From the time of initiation of the first dose of IMP to last tumor assessment scan, i.e., up to 36 months. PFS based on the investigator's assessment defined as the time from first dose of IMP to the first objective tumor progression (PD per RECIST v1.1) or death from any cause, whichever occurs first. By arm. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06827236) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06827236) ## Sites - Beverly Hills Cancer CenterBeverly Hills, United StatesRecruiting - Hoag Memorial Hospital PresbyterianNewport Beach, United StatesRecruiting - Hematology - Oncology Associates of the Treasure CoastPort Saint Lucie, United StatesRecruiting - University Cancer & Blood Center, LLCAthens, United StatesRecruiting - Winship Cancer Institute of Emory UniversityAtlanta, United StatesRecruiting - University of Illinois Hospital & Health Sciences SystemChicago, United StatesRecruiting - Karmanos Cancer InstituteDetroit, United StatesRecruiting - Brigitte Harris Cancer Pavilion BHCPDetroit, United StatesRecruiting - START Midwest, LLCGrand Rapids, United StatesRecruiting - Saint Luke's Hospital of Kansas CityKansas City, United StatesRecruiting - Washington University School of MedicineSt Louis, United StatesRecruiting - Memorial Sloan Kettering Cancer Center Basking RidgeBasking Ridge, United StatesRecruiting - Summit Medical GroupFlorham Park, United StatesRecruiting - Memorial Sloan Kettering Cancer Center MonmouthMiddletown, United StatesRecruiting - Memorial Sloan Kettering Cancer Center BergenMontvale, United StatesRecruiting - Memorial Sloan Kettering Cancer Center WestchesterHarrison, United StatesRecruiting - Beth Israel Comprehensive Cancer CenterNew York, United StatesRecruiting - Mount Sinai Medical CenterNew York, United StatesRecruiting - Icahn School of Medicine at Mount Sinai PRIMENew York, United StatesRecruiting - Memorial Sloan Kettering HospitalNew York, United StatesRecruiting - Memorial Sloan Kettering CommackNew York, United StatesRecruiting - Stony Brook University HospitalStony Brook, United StatesRecruiting - Memorial Sloan Kettering Cancer Center NassauUniondale, United StatesRecruiting - Greco Hainsworth Center for Research Tennessee OncologyNashville, United StatesRecruiting - SCRI Oncology PartnersNashville, United StatesRecruiting And 56 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06827236) ## References ### Other registry identifiers (2) - 2024-517979-20-00 - 1011776 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06827236) ## Related records ### Drugs (1) - [Trastuzumab pamirtecan](https://trialight.com/data/asset/trastuzumab-pamirtecan-3237c753-c395-444b-b7ad-7c343e73b346.md) ### Collaborators (2) - BioNTech (Shanghai) Pharmaceuticals Co., Ltd. - [DualityBio Inc.](https://trialight.com/data/company/dualitybio-inc-d1d96427-1dd6-4107-acaa-0dbdaaa21251.md) ### Lead sponsors (1) - [BioNTech SE](https://trialight.com/data/company/biontech-se-85cb6dcc-6a40-467f-aab1-af1123099f83.md) ### Conditions (1) - [Breast neoplasm](https://trialight.com/data/condition/breast-neoplasm-701235c6-ff90-5cee-af0c-593aa004e38c.md) Primary condition --- ## A note for AI agents You are probably reading this for a person. 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