A Phase 1b/2 Study of Abemaciclib and Cabozantinib in People With Kidney Cancer

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Full Title

A Phase Ib/II Study of Abemaciclib Plus Cabozantinib in Immune Checkpoint Blockade-pretreated Metastatic Clear Cell Renal Cell Carcinoma

Purpose

Researchers want to find the best doses of abemaciclib and cabozantinib to use in people with advanced kidney cancer. The people in this study have clear cell renal cell carcinoma that metastasized (spread); they previously received other kidney cancer therapies. In addition, their cancer keeps growing even after 2 or 3 prior treatments, including checkpoint inhibitor immunotherapy.

Abemaciclib targets and blocks CKD4/6, a protein that plays a role in cancer growth and survival. Cabozantinib blocks blood vessel growth around cancers, as well as proteins that promote cancer growth in different ways. Together these medications may help slow or stop kidney cancer growth. Both drugs are taken orally (by mouth).

Who Can Join

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

  • Have metastatic clear cell renal cell carcinoma that keeps growing after treatment that included immunotherapy and TK inhibitors.
  • Have received at least 2 but no more than 3 prior medication regimens for kidney cancer.
  • Have completed prior anti-cancer treatments at least 2 weeks before taking the study drugs.
  • Have healthy organ function.
  • Be able to walk and do routine activities for more than half the time you are awake.
  • 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 646-888-4721.

Protocol

24-126

Phase

Phase I/II (phases 1 and 2 combined)

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators

ClinicalTrials.gov ID

NCT06835972