This open-label Phase 1 study will evaluate the safety, tolerability, PK characteristics and preliminarily efficacy of JMKX003948 tablets in patients with renal cell carcinoma.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
80
Subjects will receive JMKX003948 tablets until disease progression
Beijing Caancer Hospital
Beijing, China
RECRUITINGDose Escalation: Number of participants with dose limiting toxicities (DLTs)
Number of participants with DLTs
Time frame: Up to 2 months
Dose Escalation: Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)
Number of participants with AEs/SAEs to characterize the safety and tolerability of JMKX003948.
Time frame: Up to 2 years
Dose Expansion: Objective Response Rate (ORR)
ORR defined as the percentage of participants with a confirmed complete response (CR) or partial response (PR) based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Time frame: Up to 1 year
maximum plasma concentration (Cmax)
Maximum observed concentration.
Time frame: Up to 1 month
maximum plasma concentration (Tmax)
Time to reach maximum observed plasma concentration.
Time frame: Up to 1 month
Duration of Response (DoR)
DoR is defined as the time from the date of first documented CR or PR, assessed by investigator and based on RECIST v. 1.1, to the documented date of progressive disease (PD) or death, whichever occurred first.
Time frame: Up to 1 year
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