A Phase 1b-2 Study of BNT324 and BNT327 in People With Advanced Lung Cancer

Full 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

Purpose

Researchers want to find the best doses of BNT324 and BNT327 when given together to treat lung cancer. The people in this study have lung cancer that spread and came back or got worse after treatment.

BNT324 is an antibody-drug conjugate. It is made up of an antibody and a chemotherapy drug. The antibody attaches to the B7-H3 protein on cancer cells, which plays a role in cancer cell growth. Once attached, the chemotherapy enters the cells and causes them to die, preventing tumor growth.

BNT327 is a bispecific antibody. It binds to and blocks the function of two proteins: PD-L1 and VEGF-A. BNT327 could boost your immune system, reduce blood supply to the tumor, and reduce tumor spread. Both BNT324  and BNT327 are given intravenously (by vein).

Who Can Join

To join this study, there are a few conditions. You must:

  • Have lung cancer that spread and came back or keeps growing after prior treatment.
  • Have recovered from the serious side effects of previous treatments before getting the study therapy.
  • Be well enough to walk and take care of yourself. You must be able to do activities such as office work or light housework.
  • Be age 18 or older.

Contact

For more information about this study or to see if you can join, please call Dr. Adam Schoenfeld’s office at 646-608-4042.

Protocol

25-297

Phase

Phase I/II (phases 1 and 2 combined)

Investigator

Co-Investigators

ClinicalTrials.gov ID

NCT06892548