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Clinical trial · no report yet · Phase 1/Phase 2

NCT06892548

A Clinical Study to Investigate the Efficacy and Safety of an Investigational Combination Therapy With BNT324 and BNT327 in Patients With Advanced Lung Cancer

We haven't built a report for this trial yet. This page shows the registry record and the public commentary we found that names the trial. A report reads that commentary and sets out what clinicians said about the trial, each point linked to its source. How reports are made.

Preliminary discovery

Commentary in our index that names this trial so far

Podcasts, YouTube videos and X posts we have indexed. A report screens them, searches for more and cites what clinicians said when it is built, so final coverage is set at build.

ChannelFound
X threads4

The trial

ClinicalTrials.gov
Official title
A Phase Ib/II, Multi-site, Open-label, Two-part Trial to Evaluate the Efficacy, Safety, Pharmacokinetics, and Recommended Combination Dose of BNT324 With BNT327 in Participants With Advanced Lung Cancer
Phase
Phase 1/Phase 2
Status
Recruiting
Conditions
Advanced Lung Cancer
Interventions
BNT324; BNT327
Arms
  • Part 1 - BNT324 + BNT327 combination therapy · Experimental
  • Part 2 - Cohort 1: RP2D of BNT324 + BNT327 and RP2D-1 of BNT324 + BNT327 · Experimental
  • Part 2 - Cohort 2: RP2D of BNT324 + BNT327 and RP2D-1 of BNT324 + BNT327 · Experimental
  • Part 2 - Cohort 3: RP2D of BNT324 + BNT327 · Experimental
  • Part 2 - Cohort 4: RP2D of BNT324 + BNT327 · Experimental
  • Part 2 - Cohort 5: RP2D of BNT324 + BNT327 · Experimental
  • Part 2 - Cohort 6: RP2D of BNT324 + BNT327 · Experimental
  • Part 2 - Cohort 7: RP2D of BNT324 + BNT327 · Experimental
Enrollment
594 (estimated)
Primary outcomes
  • Part 1 - Occurrence of dose limiting toxicities (DLTs) by dose level
  • Part 1 - Occurrence of Treatment-emergent adverse events (TEAEs), serious TEAEs, treatment-related TEAEs, and treatment-related serious TEAEs by dose level
  • Part 1 - Occurrence of dose interruption, reduction, and treatment discontinuations due to TEAEs by dose level
  • Part 2 cohorts 1 and 2 - Occurrence of TEAEs, serious TEAEs, treatment-related TEAEs, and treatment-related serious TEAEs by cohort and treatment arm
  • Part 2 cohorts 1 and 2 - Occurrence of dose interruption, reduction, and treatment discontinuation due to TEAEs by cohort and treatment arm
  • Part 2 cohorts 1 and 2 - Objective response rate (ORR) by cohort and treatment arm
  • Part 2 cohorts 3-7 - ORR by cohort
Sponsor
BioNTech SE with DualityBio Inc.
Start
May 2, 2025
Primary completion
Sep 2028 (estimated)
Results posted
No
Registry record
NCT06892548 · updated Aug 26, 2026