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Cancer Vaccine

BNT327 + Chemotherapy for Breast Cancer

Phase 2
Recruiting
Research Sponsored by BioNTech SE
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Have confirmed locally recurrent inoperable or mTNBC as defined by the most recent ASCO/CAP guidelines. 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
Male or female, aged ≥18 years at the time of giving informed consent
Must not have
Have received allogeneic hematopoietic stem cell transplantation or organ transplantation
Have active autoimmune disease that has required systemic treatment in the past 2 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from pre-dose to 21 days after study treatment
Awards & highlights
No Placebo-Only Group

Summary

This trial will test the safety and effectiveness of BNT327 at two different doses when combined with chemotherapy in patients with advanced triple-negative breast cancer.

Who is the study for?
This trial is for adults with advanced triple-negative breast cancer who haven't had systemic therapy for metastatic disease. They must have completed any prior treatment over 6 months ago, provide a recent tumor sample, and have at least one measurable lesion. Those with certain previous treatments or only one targetable lesion may not qualify.
What is being tested?
The study tests BNT327's safety and effectiveness in two doses combined with chemotherapy (Taxane A/B, Antimetabolite, Alkylating agent) for first- or second-line treatment of metastatic breast cancer. It's an open-label Phase II trial assessing how the body processes the drug too.
What are the potential side effects?
While specific side effects are not listed here, common ones from similar therapies include nausea, fatigue, hair loss from chemotherapy; plus potential unique reactions to BNT327 which will be closely monitored.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My breast cancer is triple-negative and cannot be removed by surgery.
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I am 18 years old or older.
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I am a man and I agree not to donate sperm.
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I am fully active or can carry out light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had a stem cell or organ transplant.
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I have been treated for an autoimmune disease in the last 2 years.
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I have had cancer other than lung cancer in the last 5 years.
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I still have side effects from cancer treatment that are not mild.
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I have active tuberculosis or had tuberculosis that wasn't successfully treated.
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I have cancer that has spread to my brain and meet certain conditions.
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I have an active hepatitis C infection.
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I have symptoms related to major vein or spinal cord issues.
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I have or had lung inflammation or disease needing steroid treatment.
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I have wounds or fractures that are not healing properly.
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I have a serious bleeding disorder or a high risk of bleeding.
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I need frequent procedures to remove fluid buildup in my chest or abdomen.
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My cancer pain is not controlled despite taking pain medication.
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I am currently on antiviral therapy for hepatitis B.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from pre-dose to 21 days after study treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and from pre-dose to 21 days after study treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Best percentage change from baseline in the tumor size
Objective Response Rate (ORR)
Occurrence of dose interruption, reduction, and discontinuation of study treatment due to adverse events (AEs)
+2 more
Secondary study objectives
Disease Control Rate (DCR)
Duration of Response (DOR)
ORR as assessed by the investigator
+9 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups
Experimental Treatment
Group I: Cohort 2 Arm 2 - BNT327 DL2 + Antimetabolite + Alkylating agentExperimental Treatment3 Interventions
Group II: Cohort 2 Arm 1 - BNT327 DL2 + Taxane BExperimental Treatment2 Interventions
Group III: Cohort 1 Arm 2 - BNT327 DL2 + Taxane AExperimental Treatment2 Interventions
Group IV: Cohort 1 Arm 1 - BNT327 DL1 + Taxane AExperimental Treatment2 Interventions

Find a Location

Who is running the clinical trial?

BioNTech SELead Sponsor
71 Previous Clinical Trials
111,099 Total Patients Enrolled
BioNTech Responsible PersonStudy DirectorBioNTech SE
36 Previous Clinical Trials
9,928 Total Patients Enrolled
~30 spots leftby Mar 2025
Unbiased ResultsWe believe in providing patients with all the options.
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