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

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Conditions

Advanced Lung CancerSmall 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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

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

Quick Facts

Study Start:2025-05-02
Study Completion:2031-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06892548

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Aged ≥18 years at the time of giving informed consent.
  2. * 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.
  3. * Part 1: Participants with NSCLC and SCLC
  4. * Part 2 Cohort 1: Participants with NSCLC (subpopulation 1) AGA negative, 1L
  5. * Part 2 Cohort 2: Participants with SCLC, 2L+
  6. * Part 2 Cohort 3: Participants with NSCLC (subpopulation 1) AGA negative, 2L+
  7. * Part 2 Cohort 4: Participants with NSCLC (subpopulation 2) AGA negative, 1L
  8. * Part 2 Cohort 5: Participants with NSCLC (subpopulation 2) AGA negative, 2L+
  9. * Part 2 Cohort 6: Participants with NSCLC AGA positive
  10. * Part 2 Cohort 7: Participants with SCLC, 1L
  11. * Have measurable disease defined by RECIST version 1.1.
  12. * Have an Eastern Cooperative Oncology Group performance status of 0 or 1.
  13. * Have a life expectancy of ≥12 weeks.
  1. * Prior treatment with B7-H3 targeted therapy.
  2. * 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.
  3. * 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.
  4. * 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.

Contacts and Locations

Study Contact

BioNTech clinical trials patient information
CONTACT
+49 6131 9084
patients@biontech.de

Principal Investigator

BioNTech Responsible Person
STUDY_DIRECTOR
BioNTech SE

Study Locations (Sites)

Virginia Cancer Specialists
Fairfax, Virginia, 22031
United States

Collaborators and Investigators

Sponsor: BioNTech SE

  • BioNTech Responsible Person, STUDY_DIRECTOR, BioNTech SE

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-05-02
Study Completion Date2031-06

Study Record Updates

Study Start Date2025-05-02
Study Completion Date2031-06

Terms related to this study

Keywords Provided by Researchers

  • Small cell lung cancer (SCLC)
  • Non-small cell lung cancer (NSCLC)
  • Programmed death-ligand 1 (PD-L1)
  • Vascular endothelial growth factor (VEGF)
  • Bispecific antibody
  • BNT324 (DB-1311)
  • BNT327
  • Combination with chemotherapy
  • Combination with other investigational agents
  • Immunotherapy
  • Treatment-naïve

Additional Relevant MeSH Terms

  • Advanced Lung Cancer