A Phase 1b-2 Study of BNT326 and BNT327 in People With Advanced Lung Cancer

Full Title

A Phase Ib/II, Multi-site, Open-label, Dose Finding Trial to Evaluate the Safety, Efficacy, and Pharmacokinetics of BNT326 in Combination with BNT327 in Participants with Advanced Non-small Cell Lung Cancer (NSCLC)

Purpose

Researchers are assessing the combination of BNT326 and BNT327 in people with advanced lung cancer that has spread. The people in this study have non-small cell lung cancer (NSCLC) that came back or keeps growing after treatment.

The researchers will evaluate different doses of BNT326 with an unchanging (fixed) dose of BNT327. They want to find the best dose of BNT326 to use.

BNT326 is an antibody-drug conjugate. It is made up of an antibody and a chemotherapy drug. The antibody attaches to the HER3 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 BNT326  and BNT327 are given intravenously (by vein).

Who Can Join

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

  • Have NSCLC that came back or keeps growing after treatment.
  • Have recovered from the serious side effects of previous therapies before getting the study treatment.
  • 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

25-266

Phase

Phase I/II (phases 1 and 2 combined)

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators

ClinicalTrials.gov ID

NCT07111520