BNT323 + BNT327 for Breast Cancer

Recruiting at 1 trial location

Overseen By BioNTech clinical trials patient information

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: BioNTech SE

Must not be taking: Topoisomerase inhibitors, PD-L1/VEGF, Immunostimulatory agents, Systemic corticosteroids

Disqualifiers: Small bowel obstruction, Uncontrolled illness, ILD/pneumonitis, others

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

Compensation: Varies

Number of Visits: Unknown

320 Participants Needed

Trial Summary

What is the purpose of this trial?

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 in combination with BNT327 in participants with hormone receptor-positive (HR+) or hormone receptor-negative (HR-), Human epidermal growth factor receptor (HER)2-low (immunohistochemistry \[IHC\] 1+ or IHC 2+/in situ hybridization -), HER2-ultralow (IHC 0, with membrane staining), or HER2-null breast cancer (BC).

Research Team

BioNTech Responsible Person

Principal Investigator

BioNTech SE

Eligibility Criteria

This trial is for patients with advanced breast cancer, regardless of hormone receptor status. Participants must have confirmed HER2 status and measurable disease as per specific guidelines. They need a healthy heart function (ejection fraction ≥50%). It's not suitable for those who don't meet these criteria.

Inclusion Criteria

My breast cancer is confirmed and has spread beyond the breast.

Participants must have measurable disease defined by RECIST 1.1

My breast cancer's HER2 status is confirmed by a lab.

Exclusion Criteria

I haven't been hospitalized for a small bowel obstruction in the last 3 months.

I don't have any severe illnesses that would stop me from following the study plan.

I don't have uncontrolled fluid buildup needing treatment in the last 2 weeks.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants receive BNT323 in combination with BNT327 in a dose escalation design to define the recommended Phase 2 dose (RP2D)

21 days

Multiple visits for dose escalation and monitoring

Dose Optimization and Exploratory Cohorts

Evaluation of the efficacy and safety of the optimal dose combination in three cohorts

Up to 54 months

Regular visits for treatment and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

90 days after the last IMP dose

Treatment Details

Interventions

• BNT323
• BNT327

Trial Overview The study tests the combination of two investigational drugs, BNT323 and BNT327, to find the best dose and assess their safety in treating advanced breast cancer. The trial will determine how well this drug combo works in different subgroups of breast cancer.

Participant Groups

Group I: Part1 - BNT323 + BNT327 combination therapy Experimental Treatment 2 Interventions

Escalating dose levels (DLs) of BNT323 and BNT327 to define RP2D. Six DLs are planned, i.e., DL0-1, DL1-1, DL2-1, DL0-0, DL1-0, DL2-0, a combination of three different DLs for BNT323 (DL0, DL1, and DL2) and two DLs for BNT327 (DL0 and DL1).

Group II: Part 2 Cohort 3 - Selected dose level of BNT323 + BNT327 Experimental Treatment 2 Interventions

Group III: Part 2 Cohort 2 - Selected dose level of BNT323 + BNT327 Experimental Treatment 2 Interventions

Group IV: Part 2 Cohort 1 - RP2D of BNT323 + BNT327 Experimental Treatment 2 Interventions

Group V: Part 2 Cohort 1 - Lower dose or RP2D of BNT323 + BNT327 Experimental Treatment 2 Interventions

Group VI: Part 2 Cohort 1 - BNT327 monotherapy Experimental Treatment 1 Intervention

BNT327 monotherapy at a fixed dose

Group VII: Part 2 Cohort 1 - BNT323 monotherapy Experimental Treatment 1 Intervention

BNT323 monotherapy at a fixed dose

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

DualityBio Inc.

Industry Sponsor

Trials

12

Recruited

5,800+

Biotheus Inc.

Industry Sponsor

Trials

21

Recruited

5,100+