BioNTech_BNT326-01 (Advanced Solid Tumors)

What is the Purpose of this Study?

We are doing this study to find the most effective, safe dose of an experimental drug called BNT326. We want to know how well it works when it is given on its own and in combination with an immunotherapy drug.

What is the Condition Being Studied?

Advanced Solid Tumors

Who Can Participate in the Study?

Adults ages 18+ who:

  • Are diagnosed with a solid tumor form of cancer (e.g., cutaneous melanoma, rare melanoma, non-small cell lung cancer, breast cancer)
  • Have disease that has either relapsed or is metastatic (has spread)
  • Do not have disease that has the potential to be resolved with surgery and/or radiation or ablation)

For more information, contact the study team at hollie.watson@duke.edu.

Age Group
Adults

What is Involved?

If you choose to join this study, you will participate in either Part 1 or Part 2 of the study. The part of the study in which you participate will depend on when you join the study.

  • Part 1: If you participate in this study, you will take the study drug on its own. You will get a dose of the study drug every 3 weeks.
  • Part 2: If you participate in this study, you will take the study drug in combination with an experimental immunotherapy drug called BNT327. You will get a dose of both drugs every 3 weeks.

Study Details

Full Title
A Phase I/II, open-label, adaptive two-part trial to evaluate the safety, efficacy,
optimal dose and pharmacokinetics of BNT326 as monotherapy and in
combination with cancer immunotherapies in participants with advanced solid
tumors.
Principal Investigator
Associate Professor of Medicine
Protocol Number
IRB: PRO00117681
NCT: NCT07070232
Phase
Phase I/II
ClinicalTrials.gov
Enrollment Status
INSTITUTIONAL APPROVAL SIGNOFF