BNT327 + Chemotherapy for Breast Cancer

Recruiting at 56 trial locations

Overseen By BioNTech clinical trials patient information

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: BioNTech SE

Must not be taking: Corticosteroids, Antibiotics, Immunosuppressants, others

Disqualifiers: Pregnancy, Autoimmune disease, Heart conditions, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: up to 2 years

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the safety and effectiveness of the new treatment BNT327 when combined with chemotherapy for individuals with locally advanced or metastatic triple-negative breast cancer. This type of breast cancer lacks three typical receptors known to fuel most breast cancer growth. Participants will join one of several groups to test different combinations of BNT327 and chemotherapy drugs like Eribulin, Nab-paclitaxel, and others. Ideal candidates have confirmed triple-negative breast cancer that has either returned or spread and have received little to no prior systemic treatment in this advanced setting. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Do I need to stop my current medications to join the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, it mentions that you should not have received certain treatments like systemic anticancer therapy, immunosuppressive drugs, or live vaccines within a few weeks before starting the study. It's best to discuss your current medications with the study team to see if they might affect your eligibility.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Previous studies have shown that BNT327 holds promise for treating solid tumors. This special antibody targets two proteins involved in cancer growth. Research indicates that BNT327, combined with nab-paclitaxel (a type of chemotherapy), was well-tolerated by patients with advanced triple-negative breast cancer. In one study, 78.6% of patients responded positively to the treatment.

While this data is encouraging, BNT327 remains under study. The current trial phase focuses on assessing its safety and effectiveness with different chemotherapy drugs. Treatments in this phase have generally passed initial safety tests, suggesting they are likely to be reasonably safe, but more data is needed to confirm this. Participants in such trials help researchers gather vital information about the treatment's safety and potential side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about BNT327 for breast cancer because it targets the disease differently than most current treatments. Unlike traditional chemotherapy, which attacks rapidly dividing cells in general, BNT327 is designed to work more precisely by targeting specific pathways involved in cancer cell growth. This targeted approach could potentially lead to fewer side effects and better outcomes for patients. Additionally, BNT327 is being combined with established chemotherapies like Eribulin, Nab-paclitaxel, and Gemcitabine, which may enhance the effectiveness of these drugs and offer a more robust attack on the cancer cells. These combinations might provide a more personalized and effective treatment strategy for patients with breast cancer.

What evidence suggests that this trial's treatments could be effective for breast cancer?

Research shows that BNT327, a new treatment being tested for triple-negative breast cancer (TNBC), is promising. In earlier studies, patients with advanced TNBC who received BNT327 with nab-paclitaxel had a 78.6% overall response rate, indicating significant tumor shrinkage. In this trial, participants may receive BNT327 with various chemotherapy agents, such as nab-paclitaxel, paclitaxel, eribulin, gemcitabine, or carboplatin, depending on their assigned treatment arm. BNT327 is a special type of antibody designed to target two proteins that help cancer grow. These findings suggest BNT327 could be an effective treatment option for patients with advanced TNBC. ^{1 2 3 6 7}

Who Is on the Research Team?

BioNTech Responsible Person

Principal Investigator

BioNTech SE

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Have given informed consent by signing and dating the informed consent form before initiation of any study-specific procedures

I have given a tissue sample for testing during the screening.

Have at least one measurable lesion as the targeted lesion based on RECIST 1.1

Exclusion Criteria

Are pregnant or breastfeeding or are planning pregnancy or planning to father children during the study or within 60 days or five half-lives after the last dose of IMP

Have a medical, psychological, or social condition which, in the opinion of the investigator, could compromise their wellbeing if they participate in the study

I have not had major surgery, significant injury, or invasive dental work in the last 28 days.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive BNT327 at two dose levels in combination with chemotherapeutic agents until disease progression, intolerable toxicity, participant withdrawal, death, study termination, or up to 2 years

up to 2 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

up to 24 months after completion of study treatment

What Are the Treatments Tested in This Trial?

Interventions

• BNT327

Trial Overview 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.

How Is the Trial Designed?

Group I: Cohort 2 Arm 3 - BNT327 Equivalent Q3W dose + Eribulin Experimental Treatment 2 Interventions

Group II: Cohort 2 Arm 2 - BNT327 Equivalent Q3W dose + Gemcitabine + Carboplatin Experimental Treatment 3 Interventions

Group III: Cohort 2 Arm 1 - BNT327 Optimized dose + Paclitaxel Experimental Treatment 2 Interventions

Group IV: Cohort 1 Arm 2 - BNT327 DL2 + Nab-paclitaxel Experimental Treatment 2 Interventions

Group V: Cohort 1 Arm 1 - BNT327 DL1 + Nab-paclitaxel Experimental Treatment 2 Interventions

Who Is Running the Clinical Trial?

BioNTech SE

Lead Sponsor

Trials

84

Recruited

120,000+

Prof. Dr. Ugur Sahin

BioNTech SE

Chief Executive Officer since 2008

MD from University of Cologne

Prof. Özlem Türeci

BioNTech SE

Chief Medical Officer since 2018

MD from Saarland University

Published Research Related to This Trial

Recent studies indicate that combination chemotherapy (doublet therapy) for metastatic breast cancer (MBC) can lead to higher response rates and longer progression-free survival compared to single-agent therapies, although the absolute benefits remain unclear due to lack of planned crossover in trials.

The future of MBC treatment may involve combining effective single-agent chemotherapies with novel biologic agents, such as the combination of paclitaxel and bevacizumab, which has shown promising results, but further research is needed to establish optimal treatment strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Considerations in treatment choice for metastatic breast cancer. Jones, SE.[2018]

Chemotherapy, particularly with taxoids like docetaxel and paclitaxel, shows significant activity against metastatic breast cancer, but overall survival rates remain disappointing, indicating a need for better treatment options.

Recent trials suggest that high-dose chemotherapy may lead to higher complete response rates and potential survival benefits compared to traditional dosing, highlighting the importance of ongoing research into new treatment strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optimising treatment outcomes: a review of current management strategies in first-line chemotherapy of metastatic breast cancer. Crown, J.[2019]

Metastatic breast cancer (MBC) is a complex and varied disease, with treatment decisions heavily influenced by tumor characteristics and patient factors, particularly for hormone receptor-negative and refractory hormone-positive cases where cytotoxic chemotherapy remains the primary treatment.

Recent advancements in targeted therapies, when combined with traditional chemotherapy, are showing promise in improving outcomes for patients with MBC, especially those with limited options like triple-negative breast cancer, highlighting the importance of ongoing research to identify which patients will benefit most from these new regimens.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Beyond cytotoxic chemotherapy for the first-line treatment of HER2-negative, hormone-insensitive metastatic breast cancer: current status and future opportunities. Conlin, AK., Seidman, AD.[2014]

In a phase II trial involving 56 metastatic breast cancer patients previously treated with anthracyclines, the combination of paclitaxel and vinorelbine showed a response rate of 46%, indicating significant anti-tumor activity.

The treatment was found to be safe and well-tolerated, with manageable side effects such as alopecia and myelosuppression, making it a convenient option for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Paclitaxel plus vinorelbine: an active regimen in metastatic breast cancer patients with prior anthracycline exposure. Martín, M., Lluch, A., Casado, A., et al.[2020]

In a study of 75 patients with operable breast cancer, the combination of capecitabine and vinorelbine (CV-D) showed comparable pathologic complete response (pCR) rates to the standard regimen of adriamycin and cyclophosphamide followed by docetaxel (AC-D), with pCR rates of 11% for CV-D and 15% for AC-D.

CV-D was associated with fewer severe side effects like grade 3-4 neutropenia and vomiting compared to AC-D, although it did lead to more manageable side effects such as diarrhea and hand-foot syndrome, indicating it may be a safer alternative for some patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Randomized Phase II Trial of Capecitabine Plus Vinorelbine Followed by Docetaxel Versus Adriamycin Plus Cyclophosphamide Followed by Docetaxel as Neoadjuvant Chemotherapy for Breast Cancer. Yoo, C., Kim, SB., Ahn, JH., et al.[2018]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06449222

Study Details | NCT06449222 | Safety and Preliminary ... 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 ...

2. cancernetwork.com cancernetwork.com/view/pm8002-bnt327-combo-improves-efficacy-and-safety-in-metastatic-tnbc

PM8002/BNT327 Combo Improves Efficacy and Safety in ... Data from a phase 1b/2 study show a 78.6% ORR in patients with metastatic triple-negative breast cancer treated with PM8002/BNT327 plus nab-paclitaxel.

3. annalsofoncology.org annalsofoncology.org/article/S0923-7534(24)01815-5/fulltext

348MO A phase Ib/II study to assess the safety and efficacy ... PM8002/BNT327 is a bispecific antibody targeting PD-L1 and VEGF-A developed for the treatment of solid tumors. We conducted a Phase Ib/II study of PM8002 in ...

4. aacrjournals.org aacrjournals.org/clincancerres/article/31/12_Supplement/PS3-08/754094/Abstract-PS3-08-Interim-Overall-Survival-of

Abstract PS3-08: Interim Overall Survival of Patients with ... First-line therapy with PM8002/BNT327 combined with nab-paclitaxel showed clinically meaningful survival outcomes and antitumor activity regardless of PD-L1 ...

5. investors.biontech.de investors.biontech.de/news-releases/news-release-details/first-disclosure-global-interim-phase-2-data-biontech-and

Press Release - BioNTech PD-L1xVEGF-A bispecific antibody pumitamig (BNT327/BMS986545) plus chemotherapy continues to show encouraging antitumor activity in patients ...

6. investors.biontech.de investors.biontech.de/news-releases/news-release-details/biontech-present-clinical-data-updates-across-mrna-and

BioNTech to Present Clinical Data Updates Across mRNA and ... BNT327/PM8002 is an investigational bispecific antibody combining PD-L1 checkpoint inhibition with VEGF-A neutralization for vascular normalization and ...

7. clinicaltrials.gov clinicaltrials.gov/show/NCT06449222

Study Details | NCT06449222 | Safety and Preliminary ... 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 ...