BNT324 + BNT327 for Lung Cancer

Overseen By BioNTech clinical trials patient information

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: BioNTech SE

Must not be taking: B7-H3 therapy, Topoisomerase inhibitors

Disqualifiers: Hematologic toxicity, Locoregional treatment, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 87 months

594 Participants Needed

Trial Summary

What is the purpose of this trial?

This study aims to investigate the combination of BNT324, a B7-H3 antibody-drug conjugate (ADC) with BNT327, a programmed death-ligand 1 (PD-L1) and vascular endothelial growth factor (VEGF) bispecific antibody, in participants with advanced/metastatic or relapsed/progressive small cell lung cancer (SCLC) and non small cell lung cancer (NSCLC).

Research Team

BioNTech Responsible Person

Principal Investigator

BioNTech SE

Eligibility Criteria

This trial is for adults with advanced or relapsed lung cancer, both small cell (SCLC) and non-small cell types (NSCLC). It includes those who haven't had treatment before (1L) and those who have tried at least one other therapy (2L+). NSCLC participants can join regardless of PD-L1 expression levels. Those with AGA-positive NSCLC must have had targeted therapy prior.

Inclusion Criteria

I have NSCLC, am AGA negative, and need second-line treatment or beyond.

I have NSCLC, am AGA negative, and need second-line treatment or beyond.

I have small cell lung cancer and am in the first line of treatment.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive BNT324 in combination with BNT327 using a dose escalation design in Part 1 and at RP2D or RP2D-1 in Part 2

Up to 87 months

Safety Follow-up

Participants are monitored for safety after treatment

4-8 weeks

Long-term Survival Follow-up

Participants are monitored for overall survival and other long-term outcomes

Up to 87 months

Treatment Details

Interventions

• BNT324
• BNT327

Trial Overview The study tests a new combination therapy using BNT324, an antibody-drug conjugate targeting B7-H3, alongside BNT327, which targets both PD-L1 and VEGF. The goal is to see how effective and safe this combo is for patients with different subtypes of advanced lung cancer.

Participant Groups

Group I: Part 2 - Cohort 7: RP2D of BNT324 + BNT327 Experimental Treatment 2 Interventions

In SCLC, 1L

Group II: Part 2 - Cohort 6: RP2D of BNT324 + BNT327 Experimental Treatment 2 Interventions

In NSCLC AGA positive

Group III: Part 2 - Cohort 5: RP2D of BNT324 + BNT327 Experimental Treatment 2 Interventions

In subpopulation 2 of NSCLC AGA negative, 2L+

Group IV: Part 2 - Cohort 4: RP2D of BNT324 + BNT327 Experimental Treatment 2 Interventions

In subpopulation 2 of NSCLC AGA negative, 1L

Group V: Part 2 - Cohort 3: RP2D of BNT324 + BNT327 Experimental Treatment 2 Interventions

In subpopulation 1 of NSCLC AGA negative, 2L+

Group VI: Part 2 - Cohort 2: RP2D of BNT324 + BNT327 and RP2D-1 of BNT324 + BNT327 Experimental Treatment 2 Interventions

In SCLC, second-line plus (2L+)

Group VII: Part 2 - Cohort 1: RP2D of BNT324 + BNT327 and RP2D-1 of BNT324 + BNT327 Experimental Treatment 2 Interventions

In subpopulation 1 of NSCLC actionable oncogenic alteration (AGA) negative, first-line (1L)

Group VIII: Part 1 - BNT324 + BNT327 combination therapy Experimental Treatment 2 Interventions

Escalating combination dose levels of BNT324 and BNT327 to define RP2D and RP2D-1 for NSCLC and SCLC.

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

Biotheus Inc.

Industry Sponsor

Trials

21

Recruited

5,100+

DualityBio Inc.

Industry Sponsor

Trials

12

Recruited

5,800+