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.
Who Can Participate?
Eligibility
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)
Age Range
18-110
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
Description
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.
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
No
Spanish Materials Available
No
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.
optimal dose and pharmacokinetics of BNT326 as monotherapy and in
combination with cancer immunotherapies in participants with advanced solid
tumors.
Principal Investigator
Niharika
Mettu
Protocol Number
PRO00117681
NCT ID
NCT07070232
Phase
I/II
Enrollment Status
Pending Open to Enrollment