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Safety and Preliminary Effectiveness of BNT327, an Investigational Therapy for Breast Cancer, When Given in Combination With Chemotherapy | Clinical Trials | Clareo Health

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Safety and Preliminary Effectiveness of BNT327, an Investigational Therapy for Breast Cancer, When Given in Combination With Chemotherapy

A Phase II, Multi-site, Randomized, Open-label Clinical Trial to Evaluate the Safety, Efficacy, and Pharmacokinetics of BNT327 at Two Dose Levels in Combination With Chemotherapeutic Agents as First- and Second-line Treatment in Triple-negative Breast Cancer

NCT06449222•BioNTech SE

View on ClinicalTrials.gov

Summary

This study is a Phase II, multi-site, randomized, open-label clinical study to evaluate the safety, efficacy, and pharmacokinetics (PK) of BNT327 at two dose levels in combination with chemotherapeutic agents in the first- and second-line treatment of participants with locally advanced/metastatic triple-negative breast cancer (mTNBC).

Detailed Description

Participants will be treated until disease progression, intolerable toxicity, participant withdrawal, death, study termination or up to 2 years (whichever occurs first). The study plans to randomize or assign eligible participants into two cohorts, i.e., Cohort 1 and Cohort 2. In Cohort 1, participants will be randomized to two treatment arms investigating two dose levels of BNT327 in combination with Nab-paclitaxel. Participants in Cohort 2 will be assigned to one of three treatment arms by their clinician. Cohort 2 will not begin until the appropriate dose to move forward has been determined from Cohort 1. After this, the arms in Cohort 2 exploring different chemotherapy combinations will begin to enroll. Participants in Cohort 2, Arm 1 will receive the optimal dose of BNT327 in combination with paclitaxel. Participants in Cohort 2, Arms 2 and 3, will receive the equivalent dose of BNT327 administered once every 3 weeks (Q3W) in combination with gemcitabine plus carboplatin (Arm 2), or eribulin (Arm 3).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Have given informed consent by signing and dating an informed consent form before initiation of any study-specific procedures.
•Male or female, aged ≥18 years at the time of giving informed consent.
•Are willing and able to comply with scheduled visits, the treatment schedule, the planned study assessments (including participant completed diaries) and other requirements of the study. This includes that they are able to understand and follow study-related instructions.
•Have confirmed locally recurrent inoperable or mTNBC as defined by the most recent American Society of Clinical Oncology (ASCO) / College of American Pathologists (CAP) guidelines. Note, participants initially diagnosed with hormone receptor-positive and/or HER2-positive breast cancer must have histological confirmation of TNBC in a tumor biopsy obtained from a local recurrence or distant metastasis site.
•* They have received no prior systemic therapy in the locally advanced unresectable/metastatic setting including chemotherapy, immunotherapy, or investigational agents.
•* They have completed treatment for Stage I-III breast cancer, if indicated, and ≥6 months has elapsed between the completion of treatment with curative intent (e.g., date of primary breast tumor surgery or date of last adjuvant chemotherapy administration, or date of last radiation therapy, whichever occurred last) and first documented local or distant disease recurrence. This also includes participants initially diagnosed with hormone receptor-positive and/or HER2-positive breast cancer prior to TNBC diagnosis.
•* They have received one systemic chemotherapy in the metastatic setting and have progressed on first line therapy. Radiographic progression must have been documented. Radiographic progression is defined as unequivocal progression of existing tumor lesions or developing new tumor lesions as assessed by the investigator.
•* They have had a recurrence-free interval of ≥6 months if they have received treatment with curative intent in the past. A recurrence-free interval of ≥6 months is required for all participants (both first- and second-line treatment settings) who have received prior treatment for breast cancer with curative intent.

Exclusion Criteria

•Have at least one measurable lesion as the targeted lesion based on RECIST version 1.1. Lesions treated after prior local treatment (radiotherapy, ablation, interventional procedures) are generally not considered as target lesions. If the lesion with prior local treatment is the only targeted lesion, evidence-based radiology must be provided to demonstrate disease progression (the single bone metastasis or the single central nervous system metastasis should not be considered as a measurable lesion).
•Eastern Cooperative Oncology Group performance status of 0 or 1.
•Have a minimum life expectancy of \>3 months.
•Have adequate organ function, as defined below:
•* Hematology:
•* Absolute neutrophil count ≥1.5 × 10\^9/L (without G-CSF support within two weeks prior to Cycle 1, Day 1).
•* Platelet count ≥100 × 10\^9/L (without transfusion within 2 weeks prior to Cycle 1, Day 1).
•* Hemoglobin ≥90 g/L or 5.6 mmol/L. Note: Criterion must be met without packed red blood cell transfusion or without erythropoietin dependency within the prior 2 weeks before receiving the first dose of study treatment.
•* Liver function:
•* Total bilirubin ≤1.5 × upper limit of normal (ULN).
+55 more criteria

Locations (31)

Beverly Hills Cancer Center

Beverly Hills, California, United States

Valkyrie Clinical Trials

Los Angeles, California, United States

Stanford University School of Medicine - Stanford Cancer Institute (SCI) - Stanford Women's Cancer Center

Palo Alto, California, United States

Saint John's Health Center - John Wayne Cancer Institute (JWCI)

Santa Monica, California, United States

Rocky Mountain Cancer Centers (RMCC)

Denver, Colorado, United States

Yale University - Yale Cancer Center

New Haven, Connecticut, United States

Carle Foundation Hospital d/b/a Carle Cancer Center

Urbana, Illinois, United States

HealthPartners Regions Specialty Clinics

Saint Louis Park, Minnesota, United States

Rutgers Cancer Institute of NJ (Rutgers, The State University of New Jersey)

New Brunswick, New Jersey, United States

Stony Brook University Hospital

Stony Brook, New York, United States

Key Dates

Start Date

August 26, 2024

Primary Completion Date

August 1, 2028

Completion Date

June 1, 2029

Last Updated

February 25, 2026

Enrollment

ACTUAL participants

Conditions

Locally Advanced Breast CancerTriple Negative Breast CancerMetastatic Triple Negative Breast Cancers

Interventions

BNT327 Dose Level 1 (DL1)

DRUG

BNT327 Dose Level 1 (DL2)

DRUG

Nab-placlitaxel

DRUG

Carboplatin

DRUG

Gemcitabine

DRUG

Paclitaxel

DRUG

Eribulin

DRUG

BNT327 Optimized Dose

DRUG

BNT327 Equivalent Q3W Dose

DRUG

Platform Study of ADC Rechallenge in ADC-treated Metastatic Breast Cancer

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 25, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Safety and Preliminary Effectiveness of BNT327, an Investigational Therapy for Breast Cancer, When Given in Combination With Chemotherapy

Inclusion Criteria

Exclusion Criteria

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