A Clinical Study to Investigate the Efficacy and Safety of an Investigational Combination Therapy With BNT324 and BNT327 in Patients With Advanced Lung Cancer
NCT ID: NCT06892548
Last Updated: 2025-11-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
594 participants
INTERVENTIONAL
2025-05-02
2031-06-30
Brief Summary
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Detailed Description
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The study consists of a screening period, a treatment period, a safety follow-up period, and a long-term survival follow-up period.
In Part 1 participants with histologically or cytologically confirmed relapsed or progressive lung cancer (both SCLC and NSCLC are eligible) will receive BNT324 in combination with BNT327 using a dose escalation design.
In Part 2 of the study, BNT324 will be studied in combination with BNT327 at the RP2D compared to RP2D-1 in participants with advanced metastatic treatment-naïve NSCLC (DO Cohort 1) and relapsed/progressive SCLC after failure of cytotoxic chemotherapy with or without immuno-oncology (IO) (DO Cohort 2). The totality of the available data (e.g., safety, efficacy, pharmacokinetics etc.) will be reviewed to select the optimal dose. After the optimal dose is selected, additional participants in each cohort may be enrolled in the selected optimal dose.
In the signal seeking cohorts (Cohort 3-7), participants will receive BNT324 in combination with BNT327 at the RP2D from Part 1.
A predefined number of participants in Part 2 Cohort 1 and Cohort 2 will be randomized to one of the two dose levels (RP2D and RP2D-1) selected from Part 1 in a 1:1 ratio. Additional participants in Part 2 Cohort 1 and Cohort 2 may be enrolled in the selected optimal dose to further assess the efficacy and safety profile.
No randomization is planned for any other cohort in Part 2 or Part 1.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Part 1 - BNT324 + BNT327 combination therapy
Escalating combination dose levels of BNT324 and BNT327 to define RP2D and RP2D-1 for NSCLC and SCLC.
BNT324
Intravenous infusion
BNT327
Intravenous infusion
Part 2 - Cohort 1: RP2D of BNT324 + BNT327 and RP2D-1 of BNT324 + BNT327
In subpopulation 1 of NSCLC actionable oncogenic alteration (AGA) negative, first-line (1L)
BNT324
Intravenous infusion
BNT327
Intravenous infusion
Part 2 - Cohort 2: RP2D of BNT324 + BNT327 and RP2D-1 of BNT324 + BNT327
In SCLC, second-line plus (2L+)
BNT324
Intravenous infusion
BNT327
Intravenous infusion
Part 2 - Cohort 3: RP2D of BNT324 + BNT327
In subpopulation 1 of NSCLC AGA negative, 2L+
BNT324
Intravenous infusion
BNT327
Intravenous infusion
Part 2 - Cohort 4: RP2D of BNT324 + BNT327
In subpopulation 2 of NSCLC AGA negative, 1L
BNT324
Intravenous infusion
BNT327
Intravenous infusion
Part 2 - Cohort 5: RP2D of BNT324 + BNT327
In subpopulation 2 of NSCLC AGA negative, 2L+
BNT324
Intravenous infusion
BNT327
Intravenous infusion
Part 2 - Cohort 6: RP2D of BNT324 + BNT327
In NSCLC AGA positive
BNT324
Intravenous infusion
BNT327
Intravenous infusion
Part 2 - Cohort 7: RP2D of BNT324 + BNT327
In SCLC, 1L
BNT324
Intravenous infusion
BNT327
Intravenous infusion
Interventions
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BNT324
Intravenous infusion
BNT327
Intravenous infusion
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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.
18 Years
ALL
No
Sponsors
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DualityBio Inc.
INDUSTRY
Biotheus Inc.
INDUSTRY
BioNTech SE
INDUSTRY
Responsible Party
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Principal Investigators
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BioNTech Responsible Person
Role: STUDY_DIRECTOR
BioNTech SE
Locations
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Precision NextGen Oncology and Research Center
Beverly Hills, California, United States
Cedars Sinai Medical Center
Los Angeles, California, United States
John Theurer Cancer Center at Hackensack UMC
Hackensack, New Jersey, United States
Memorial Sloan Kettering Cancer Center (MSKCC)
New York, New York, United States
Icahn School of Medicine at Mount Sinai PRIME
New York, New York, United States
Texas Oncology - Northeast
Tyler, Texas, United States
Virginia Cancer Specialists
Fairfax, Virginia, United States
Sunshine Hospital
Saint Albans, Victoria, Australia
Guangxi Medical University Cancer Hospital
Nanning, Guangxi Zhuang, China
Xiangyang Central Hospital
Xiangyang, Hubei, China
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
Linyi Cancer Hospital
Shandong, Linyi, China
Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine
Hangzhou, Zhejiang, China
Adana City Hospital
Adana, , Turkey (Türkiye)
Hacettepe University Medical Faculty
Ankara, , Turkey (Türkiye)
Dr. Abdurrahman Yurtaslan Oncology Teaching and Research Hospital
Ankara, , Turkey (Türkiye)
Yeditepe University Medical School Hospital
Istanbul, , Turkey (Türkiye)
Bristol Haematology and Oncology Centre
Bristol, , United Kingdom
St. James's University Hospital
Leeds, , United Kingdom
University College London Hospital
London, , United Kingdom
Countries
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Central Contacts
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BioNTech clinical trials patient information
Role: CONTACT
Phone: +49 6131 9084
Email: [email protected]
Other Identifiers
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2024-520238-31-00
Identifier Type: CTIS
Identifier Source: secondary_id
BNT324-01
Identifier Type: -
Identifier Source: org_study_id