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Tests treatment safety and results for Advanced Lung Cancer
Official title A Clinical Study to Investigate the Efficacy and Safety of an Investigational Combination Therapy With BNT324 and BNT327 in Patients With Advanced Lung Cancer
ClinicalTrials.gov ID: NCT06892548
What this study is testing
What is BNT324?
BNT324 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for advanced lung cancer.
Also referred to as DB-1311.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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+
You likely can't join if
- 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...
- Is a candidate to locoregional treatment (including surgical resection, stereotactic radiotherapy or tumor ablation) with potential to induce...
- Has a history of significant hematologic toxicity to prior lines of therapy, as assessed by investigator, e.g., Grade 4 febrile neutropenia or...
See the full eligibility criteria
- 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...
- 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.
- 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...
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Phoenix, Arizona, United States
- Beverly Hills, California, United States
- Los Angeles, California, United States
- Santa Monica, California, United States
- Aurora, Colorado, United States
- Jacksonville, Florida, United States
- Iowa City, Iowa, United States
- Rochester, Minnesota, United States
- Hackensack, New Jersey, United States
- New York, New York, United States
- Cleveland, Ohio, United States
- Dallas, Texas, United States
- Houston, Texas, United States
- Tyler, Texas, United States
- Fairfax, Virginia, United States
- Camperdown, New South Wales, Australia
- Bedford Park, South Australia, Australia
- Bendigo, Victoria, Australia
- Geelong, Victoria, Australia
- Saint Albans, Victoria, Australia
+ 53 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Phoenix, Arizona, United States; Beverly Hills, California, United States; Los Angeles, California, United States; Santa Monica, California, United States; Aurora, Colorado, United States; Jacksonville, Florida, United States and 67 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.