A Phase 1 Study of Casdatifan Alone and With Zimberelimab in People With Clear Cell Kidney Cancer

Full Title

A Phase 1, Open-label, Dose Escalation and Dose Expansion Study, to Investigate the Safety, Tolerability, and Pharmacokinetic Profile of AB521 Monotherapy and Combination Therapies in Participants with Clear Cell Renal Cell Carcinoma and Other Solid Tumors

Purpose

Researchers are studying how casdatifan, alone or with zimberelimab, works in people with kidney cancer. The people in this study have clear cell renal cell carcinoma. Their cancers have metastasized (spread) or are inoperable (cannot be taken out with surgery).

Casdatifan works by blocking a protein called HIF-2-alpha, which helps cancer cells grow. By blocking this protein, casdatifan may slow tumor growth and cause cancer cells to die. It is taken orally (by mouth).

Zimberelimab takes the brakes off the immune response so the immune system can find and destroy cancer cells. It is given intravenously (by vein).

If you take part in this study, you will get one of these treatments:

  • Casdatifan plus zimberelimab.
  • Casdatifan alone.

Who Can Join

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

  • Have metastatic or inoperable clear cell renal cell carcinoma.
  • 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 Dr. Martin Voss’ office at 646-888-4716.

Protocol

25-180

Phase

Phase I (phase 1)

Disease Status

Newly Diagnosed & Relapsed/Refractory

Investigator

Co-Investigators

ClinicalTrials.gov ID

NCT05536141