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Study details
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A Clinical Trial to Find the Optimal Dose of BNT323 and BNT327 for Advanced Breast Cancer

BioNTech SE
NCT IDNCT06827236ClinicalTrials.gov data as of Apr 2026
Phase

Phase 1/2

Target enrollment

380

Study length

about 4.1 years

Ages

18+

Locations

9 sites in CA, FL, GA +5

About this study

This trial is testing a combination treatment, BNT323 and BNT327, in people with advanced breast cancer. The goal is to find the best dose of this combination and see if it's safe and helpful.

Based on ClinicalTrials.gov records.

What participants do

  • 1.Take BNT323
  • 2.Take BNT327
PhasePhase 1/Phase 2
Primary goalOccurrence of Treatment-emergent adverse events (TEAEs), Grade ≥3 TEAEs, serious adverse events (SAEs), treatment-related TEAEs, treatment-related Grade ≥3 TEAEs, and treatment-related SAEs

Participation effort

Estimated from trial records. Details can vary by site.

Time + visits
Low8%
Logistics
Moderate50%

Logistics difficulty varies by site location and availability.

Trial highlights

Treatment details

Auto-extracted from trial records to preview treatments and outcomes.

Endpoints

Primary: Occurrence of Treatment-emergent adverse events (TEAEs), Grade ≥3 TEAEs, serious adverse events (SAEs), treatment-related TEAEs, treatment-related Grade ≥3 TEAEs, and treatment-related SAEs, Occurrence of dose interruption, reduction, and discontinuation due to TEAEs, Part 2 - Objective response rate (ORR)

Secondary: Part 1 - ORR, Part 2 - Disease control rate (DCR), Part 2 - Duration of response (DoR), Part 2 Cohort 1 only - Progression free survival (PFS)

Body systems

Oncology