A Clinical Study to Investigate the Efficacy and Safety of an Investigational Combination Therapy With BNT324 and BNT327 in Patients With Advanced Lung 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).

Conditions

Advanced Lung Cancer

Study Overview

Study Details

Study overview

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).

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

A Clinical Study to Investigate the Efficacy and Safety of an Investigational Combination Therapy With BNT324 and BNT327 in Patients With Advanced Lung Cancer

Condition
Advanced Lung Cancer
Intervention / Treatment

-

Contacts and Locations

Fairfax

Virginia Cancer Specialists, Fairfax, Virginia, United States, 22031

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.

For general information about clinical research, read Learn About Studies.

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 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.
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

BioNTech SE,

BioNTech Responsible Person, STUDY_DIRECTOR, BioNTech SE

Study Record Dates

2031-06