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
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
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).
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Official eligibility criteria
Inclusion 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 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 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.
Study sites (17)
AZ
- Mayo Clinic Arizona · Phoenix, AZ 13400More trials in Phoenix
CA
- Precision NextGen Oncology and Research Center · Beverly Hills, CA 90212More trials in Beverly Hills
- Cedars Sinai Medical Center · Los Angeles, CA 90048More trials in Los Angeles
- UCLA - David Geffen School of Medicine · Santa Monica, CA 90404More trials in Santa Monica
CO
- University of Colorado Cancer Center · Aurora, CO 80045More trials in Aurora
FL
- Mayo Clinic in Florida · Jacksonville, FL 32224More trials in Jacksonville
IA
- University of Iowa Hospitals & Clinics PARENT · Iowa City, IA 52242More trials in Iowa City
MN
- Mayo Clinic-Rochester · Rochester, MN 55905More trials in Rochester
NJ
- Regional Cancer Care Associates · Belleville, NJ 07109More trials in Belleville
- John Theurer Cancer Center at Hackensack UMC · Hackensack, NJ 07601More trials in Hackensack
NY
- Memorial Sloan Kettering Cancer Center (MSKCC) · New York, NY 10021More trials in New York
- Icahn School of Medicine at Mount Sinai PRIME · New York, NY 10029More trials in New York
OH
- Cleveland Clinic Taussig Cancer Institute Case Comprehensive Cancer Center · Cleveland, OH 44195More trials in Cleveland
TX
- Texas Oncology - DFW · Dallas, TX 75246More trials in Dallas
- MD Anderson Cancer Center · Houston, TX 77030More trials in Houston
- Texas Oncology - Northeast · Tyler, TX 75702More trials in Tyler
VA
- Virginia Cancer Specialists · Fairfax, VA 22031More trials in Fairfax