West Cancer Center

BREAST: METASTATIC: TNBC: 1st/2nd Line: BNT327-02

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

Title

BionTech BNT327-02 Metastatic TNBC

Study Title

Site Link

NCT06449222

Malignancy

TNBC, Triple negative breast cancer, IDC

Stage

Stage 4

Disease Setting

Metastatic/Palliative

Line Of Therapy

1st or 2nd line

Investigational Agent

BNT327

Drug Class

Bispecific PD-L1/VEGF ADC

Greg Vidal, MD, PhD

Sponsor

Biontech

Phase

Phase 2

Status

Open to Enrollment

Key Eligibility Criteria

Key Eligibility Criteria Details

Confirmed locally recurrent inoperable or metastatic TNBC
1st line or 2nd line. Can have received (neo)adjuvant therapy if >6 months have passed between end of therapy and development of recurrent/metastatic disease
Measurable disease
ECOG PS 0-1
No symptomatic brain mets
No active autoimmune disease
No other cancer within 2 years
No poorly controlled diabetes

Objective

Primary
- Safety
- ORR
Secondary
- PK
- DOR
- DCR
- TTR
- PFS
- OS

Assessment Frequency

Assessment Frequency 2

Assessment Frequency Link

Path

Triple negative

Dosing Frequency

Control Agents

Study Protocol

Randomized