A Study of Abemaciclib and Cabozantinib in People With Clear Cell Renal Cell Carcinoma (ccRCC) (NCT06835972) | Clinical Trial Compass
RecruitingPhase 1/2
A Study of Abemaciclib and Cabozantinib in People With Clear Cell Renal Cell Carcinoma (ccRCC)
United States43 participantsStarted 2025-02-14
Plain-language summary
The researchers are doing this study to find out whether the combination of abemaciclib and cabozantinib is a safe and effective treatment for people with metastatic clear cell renal cell carcinoma (ccRCC) and translocation-associated renal cell cancer (tRCC). The researchers will test different doses of the study drugs to find the highest doses that cause few or mild side effects in participants.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Age ≥ 18 years at the time of informed consent
* Patient must be able to provide informed consent, or a legal authorized representative (LAR) must be identified to provide consent in cases where the patient cannot
* Signed and dated IRB-approved Informed Consent Form
* Patient must have a histologically confirmed diagnosis of metastatic stage IV clear cell renal cell carcinoma or metastatic stage IV translocation-associated renal cell carcinoma.
* Patient should have availability of archival tissue that enables definitive diagnosis of ccRCC or tRCC, per review at participating site, accompanied by an associated pathology report. Specimens can be collected by surgical resection or biopsy of the primary tumor or biopsy or resection of a metastatic lesion. NOTE: If archival tissue is unavailable, a patient can still enroll onto the study with documented confirmation from the study PI.
* Patients must have at least one extra-skeletal, extracranial measurable lesion as defined by RECIST v1.1
* Patients must have Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
* Patients must have received prior therapy with at least 2 approved systemic agents and a maximum of 3 prior lines of systemic therapy. Prior adjuvant therapy is permitted.
* Patient must have progressed on 1 prior PD-1 or PD-L1 targeted treatment and prior VEGFR directed TKI therapy
* Patients must have recovered to baseline or \< Grade 1 CTCAE v5.0 from toxicities related to any prio…