Phase 1b2 Evaluation of Abemaciclib and Cabozantinib for Metastatic Clear Cell and Translocation Renal Cell Carcinoma After Prior Immunotherapy

What this Trial Is About

Researchers are evaluating the safety and dosing of a combination treatment using abemaciclib and cabozantinib for adults with metastatic clear cell renal cell carcinoma ccRCC and translocation-associated renal cell carcinoma tRCC who have previously received immunotherapy. This phase 1b2 clinical trial aims to find the highest doses of these drugs that cause few or mild side effects, helping to establish safe and tolerable treatment levels for this patient group. The trial is sponsored by Memorial Sloan Kettering Cancer Center and involves patients whose cancer has progressed after prior therapies. Participants will receive both abemaciclib taken orally twice daily and cabozantinib taken orally once daily. The study includes a dose escalation phase to determine the maximally tolerated doses followed by a dose expansion phase 2 trial to further evaluate the treatment. This trial is a single-arm, open-label study conducted at two sites, focusing on patients with measurable metastatic lesions and prior exposure to specific systemic therapies. During the study, participants will be closely monitored with regular assessments including laboratory tests to check blood counts and organ functions. Researchers will track the highest dose participants can tolerate over one year and measure how the tumors respond to treatment. Safety and side effects will be carefully observed throughout the trial. The total study duration runs until early 2027, with ongoing evaluations to understand the treatments effects and tolerability.

A Study of Abemaciclib and Cabozantinib in People With Clear Cell Renal Cell Carcinoma (ccRCC)