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 TumorsPurpose
Researchers are assessing BNT326 alone or with BNT327 to treat advanced solid tumors. The people in this study have cancers that have come back or keep growing after treatment, including:
- Melanoma of the skin
-
Non-small cell lung cancer
- Bile duct cancer (cholangiocarcinoma)
- Liver cancer (hepatocellular carcinoma)
- Kidney cancer (renal cell carcinoma)
- Uterine (endometrial) cancer
- Pancreatic cancer
- Neuroendocrine cancer
- HER2-negative breast cancer
BNT326 is a type of drug called an antibody-drug conjugate (ADC). ADCs are made of a monoclonal antibody linked to a drug. The antibody binds to a protein on cancer cells called HER3, which plays a role in cancer cell growth. It then releases the anti-cancer drug to kill the cancer cell. By destroying these cells, BNT326 may help slow or stop the growth of your cancer. It is given intravenously (by vein).
BNT327 binds to one protein on the surface of cancer cells and another on the surface of immune cells. It may strengthen your immune system’s ability to fight cancer cells by activating your own cells to destroy your tumor. BNT327 is given intravenously. Only people with melanoma or breast cancer may be offered the combination of BNT326 and BNT327.
Who Can Join
To join this study, there are a few conditions. You must:
- Have one of the advanced cancers listed above.
- Have recovered from the serious side effects of prior 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 or to see if you can join this study, please call 646-888-4226.