This is a Phase I Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of CM082 in Combination with Everolimus in Chinese Patients With Advanced Renal Cell Carcinoma.
This is a Phase I Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of CM082 in Combination with Everolimus in Chinese Patients With Renal Cell Carcinoma (RCC). After the maximum tolerated dose (MTD) or the optimal biological dose is identified, an expansion cohort of \~10 advanced renal cell carcinoma patients will be enrolled to further characterize the safety and tumor response by CT.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
18
CM082 tablets taken orally once a day on 28-day cycles
Everolimus tablets taken orally once a day on 28-day cycles
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
RECRUITINGMaximum Tolerated Dose
To determine the Maximum Tolerated Dose of the Combination in Chinese RCC Patients
Time frame: 12 months
Pharmacokinetics assessed by area under the plasma concentration versus time curve (AUC) of CM082 and everolimus
Time frame: 12 months
Objective response rate
Objective response rate (ORR)
Time frame: 18 months
Progress free survival
Progress free survival (PFS)
Time frame: 24 months
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