NCT06449222

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

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 83 (actual)
• Sponsor: BioNTech SE · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Locally Advanced Breast Cancer
• Triple Negative Breast Cancer
• Metastatic Triple Negative Breast Cancers

Interventions

Type	Name	Description
DRUG	BNT327 Dose Level 1 (DL1)	Intravenous (IV) infusion
DRUG	BNT327 Dose Level 1 (DL2)	IV infusion
DRUG	Nab-placlitaxel	IV infusion
DRUG	Carboplatin	IV infusion
DRUG	Gemcitabine	IV infusion
DRUG	Paclitaxel	IV infusion
DRUG	Eribulin	IV infusion
DRUG	BNT327 Optimized Dose	IV infusion
DRUG	BNT327 Equivalent Q3W Dose	IV infusion

Timeline

• Start date: 2024-08-26
• Primary completion: 2028-08-01
• Completion: 2029-06-01
• First posted: 2024-06-07
• Last updated: 2026-02-25

Locations

31 sites across 4 countries: United States, Australia, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study