Status:
RECRUITING
A Clinical Study to Investigate the Efficacy and Safety of an Investigational Combination Therapy With BNT324 and BNT327 in Patients With Advanced Lung Cancer
Lead Sponsor:
BioNTech SE
Collaborating Sponsors:
DualityBio Inc.
Biotheus Inc.
Conditions:
Advanced Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
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) bispecifi...
Detailed Description
This is a two-part study designed to evaluate and establish two safe combination dose levels (recommended Phase 2 dose \[RP2D\] and a lower/another combination dose level \[RP2D-1\]) of BNT324 with BN...
Eligibility Criteria
Inclusion
- Aged ≥18 years at the time of giving informed consent.
- Histological or cytological confirmed unresectable advanced/metastatic lung cancer. Histological classification may be based on tumor samples prior to metastatic disease. Participants with mixed histology must be classified based on the main component. Participants with NSCLC are eligible with any or no PD-L1 expression. Participants with AGA-positive disease must have received targeted therapy prior to enrollment in this study.
- Part 1: Participants with NSCLC and SCLC
- Part 2 Cohort 1: Participants with NSCLC (subpopulation 1) AGA negative, 1L
- Part 2 Cohort 2: Participants with SCLC, 2L+
- Part 2 Cohort 3: Participants with NSCLC (subpopulation 1) AGA negative, 2L+
- Part 2 Cohort 4: Participants with NSCLC (subpopulation 2) AGA negative, 1L
- Part 2 Cohort 5: Participants with NSCLC (subpopulation 2) AGA negative, 2L+
- Part 2 Cohort 6: Participants with NSCLC AGA positive
- Part 2 Cohort 7: Participants with SCLC, 1L
- Have measurable disease defined by RECIST version 1.1.
- Have an Eastern Cooperative Oncology Group performance status of 0 or 1.
- Have a life expectancy of ≥12 weeks.
Exclusion
- Prior treatment with B7-H3 targeted therapy.
- Prior treatment with ADC with topoisomerase inhibitor (e.g., datopotamab deruxtecan, trastuzumab deruxtecan). Note: This exclusion applies to participants in the first-line/treatment-naïve cohorts in the advanced/metastatic setting. Prior treatment with ADC with topoisomerase inhibitor payload is only allowed for participants in the second-line plus cohorts in the advanced/metastatic setting.
- Is a candidate to locoregional treatment (including surgical resection, stereotactic radiotherapy or tumor ablation) with potential to induce complete or near complete response and prolonged tumor control (sometimes described as "radical" intent), per investigator's assessment.
- Has a history of significant hematologic toxicity to prior lines of therapy, as assessed by investigator, e.g., Grade 4 febrile neutropenia or recurrent/persistent Grade 3 to 4 neutropenia.
- NOTE: Other protocol defined Inclusion/Exclusion criteria may apply to all or some participants depending on the cohort.
Key Trial Info
Start Date :
May 2 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2031
Estimated Enrollment :
594 Patients enrolled
Trial Details
Trial ID
NCT06892548
Start Date
May 2 2025
End Date
June 1 2031
Last Update
December 10 2025
Active Locations (28)
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1
Precision NextGen Oncology and Research Center
Beverly Hills, California, United States, 90212
2
Cedars Sinai Medical Center
Los Angeles, California, United States, 90048
3
John Theurer Cancer Center at Hackensack UMC
Hackensack, New Jersey, United States, 07601
4
Memorial Sloan Kettering Cancer Center (MSKCC)
New York, New York, United States, 10021