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

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Memorial Sloan Kettering Cancer Center
Study ID
NCT06835972
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Abemaciclib — DRUG
    twice a day, orally
  • Cabozantinib — DRUG
    once daily, orally

Study Details

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.

Key Dates

Start date
Feb 14, 2025
Status verified
May 2026
Primary completion
Feb 28, 2027
Completion
Feb 28, 2027

Study Design

Enrollment
43 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Abemaciclib and Cabozantinib
    This is a two-site single-arm open-label phase 1b/2 clinical trial evaluating abemaciclib plus cabozantinib in patients with metastatic ccRCC and tRCC that have progressed on therapy. The study comprises a dose escalation portion followed by a dose expansion phase 2 trial.

Primary Outcome Measure

Maximally Tolerated Dose (MTD) (Phase Ib) [ Time Frame: 1 year ]

Central Contacts

Locations (8)

FacilityCityStateZIPSite coordinators
Johns Hopkins University (Data Collection Only)BaltimoreMaryland21287
Yasser Ged, M.B.B.S
410-502-7683
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)Basking RidgeNew Jersey07920
Sahil Doshi, MD
646-422-4341
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)MiddletownNew Jersey07748
Sahil Doshi, MD
646-422-4341
Memorial Sloan Kettering Bergen (Limited Protocol Activities)MontvaleNew Jersey07645
Sahil Doshi, MD
646-422-4341
Memorial Sloan Kettering Cancer Center Suffolk - Commack (Limited Protocol Activities)CommackNew York11725
Sahil Doshi, MD
646-422-4341
Memorial Sloan Kettering West Harrison (Limited Protocol Activities)HarrisonNew York10604
Sahil Doshi, MD
646-422-4341
Memorial Sloan Kettering Cancer Center (All Protocol Activites)New YorkNew York10065
Sahil Doshi, MD
646-422-4341
Memorial Sloan Kettering Nassau (Limited Protocol Activities)UniondaleNew York11553
Sahil Doshi, MD
646-422-4341

Find similar trials in Baltimore, MD

By condition
Kidney cancer
By specialty
OncologyUrology
By research site
Johns Hopkins University (Data Collection Only)· Baltimore, MDMemorial Sloan Kettering Basking Ridge (Limited Protocol Activities)· Basking Ridge, NJMemorial Sloan Kettering Monmouth (Limited Protocol Activities)· Middletown, NJMemorial Sloan Kettering Bergen (Limited Protocol Activities)· Montvale, NJMemorial Sloan Kettering Cancer Center Suffolk - Commack (Limited Protocol Activities)· Commack, NYMemorial Sloan Kettering West Harrison (Limited Protocol Activities)· Harrison, NY

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