NCT06892548|RecruitingPhase 1FDA Drug

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

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

BioNTech SE ClinicalTrials.gov

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2 other identifiers

BNT324-012024-520238-31-00

Study Type

interventional

Target

594

Locations

6 countries

Sites

Timeline

RegisteredMar 2025

StartedMay 2025

CompletionJun 2031

Brief Summary

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).

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

594

participants targeted

Target at P75+ for phase_1

Timeline

62mo left

Started May 2025

Longer than P75 for phase_1

Geographic Reach

6 countries

58 active sites

Status

recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

6.1 years study duration

Study Progress17%

May 2025Jun 2031

First Submitted

Initial submission to the registry

March 19, 2025

Completed

5 days until next milestone

First Posted

Study publicly available on registry

March 24, 2025

Completed

1 month until next milestone

Study Start

First participant enrolled

May 2, 2025

Completed

2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2027

Expected

3.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2031

Last Updated

April 15, 2026

Status Verified

April 1, 2026

Enrollment Period

2.2 years

First QC Date

March 19, 2025

Last Update Submit

April 14, 2026

Conditions

Advanced Lung Cancer

Keywords

Small cell lung cancer (SCLC)Non-small cell lung cancer (NSCLC)Programmed death-ligand 1 (PD-L1)Vascular endothelial growth factor (VEGF)Bispecific antibodyBNT324 (DB-1311)BNT327Combination with chemotherapyCombination with other investigational agentsImmunotherapyTreatment-naïve

Outcome Measures

Primary Outcomes (7)

Part 1 - Occurrence of dose limiting toxicities (DLTs) by dose level
During the DLT evaluation period, i.e., the time of initiation of the first dose of investigational medicinal product (IMP) up to 21 days]
Part 1 - Occurrence of Treatment-emergent adverse events (TEAEs), serious TEAEs, treatment-related TEAEs, and treatment-related serious TEAEs by dose level
From the time of the first dose of IMP to 90 days after the last IMP dose or until new anticancer therapy is started, whichever occurs first
Part 1 - Occurrence of dose interruption, reduction, and treatment discontinuations due to TEAEs by dose level
From the time of the first dose of IMP to 90 days after the last dose of IMP or until new anticancer therapy is started, whichever occurs first
Part 2 cohorts 1 and 2 - Occurrence of TEAEs, serious TEAEs, treatment-related TEAEs, and treatment-related serious TEAEs by cohort and treatment arm
From the time of the first dose of IMP to 90 days after the last IMP dose or until new anticancer therapy is started, whichever occurs first
Part 2 cohorts 1 and 2 - Occurrence of dose interruption, reduction, and treatment discontinuation due to TEAEs by cohort and treatment arm
From the time of the first dose of IMP to 90 days after the last IMP dose or until new anticancer therapy is started, whichever occurs first
Part 2 cohorts 1 and 2 - Objective response rate (ORR) by cohort and treatment arm
ORR defined as the proportion of participants in whom a confirmed complete response (CR) or partial response (PR) is observed as best overall response (per response evaluation criteria in solid tumors \[RECIST\] version 1.1 based on the investigator's assessment).
From the time of initiation of the first dose of IMP to end of study, i.e., up to 87 months
Part 2 cohorts 3-7 - ORR by cohort
ORR, defined as the proportion of participants in whom a confirmed CR or PR is observed as best overall response (per RECIST version 1.1 based on the investigator's assessment).
From the time of initiation of the first dose of IMP to end of study, i.e., up to 87 months

Secondary Outcomes (9)

Part 1 - ORR by dose level
From the time of initiation of the first dose of IMP to end of study, i.e., up to 87 months
Part 1 - Disease control rate (DCR) by dose level
From the time of initiation of the first dose of IMP to end of study, i.e., up to 87 months
Part 2 all cohorts - (PFS) by cohort and treatment arm
From the time of initiation of the first dose of IMP to end of study, i.e., up to 87 months
Part 2 all cohorts - Duration of response (DOR) by cohort and treatment arm
From the time of initiation of the first dose of IMP to end of study, i.e., up to 87 months
Part 2 all cohorts - Overall survival (OS) by cohort and treatment arm
From the time of initiation of the first dose of IMP to end of study, i.e., up to 87 months
+4 more secondary outcomes

Study Arms (8)

Part 1 - BNT324 + BNT327 combination therapy

EXPERIMENTAL

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