This is a first-in-human, Phase I, open-label, multi-center, dose-escalation and dose expansion study to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of JMKX005425 in subjects with microsatellite instability-high (MSI) and/or mismatch repair deficiency (dMMR) advanced solid tumors.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
102
JMKX005425 administered orally.
Beijing Cancer Hospital
Beijing, China
RECRUITINGNumber of participants with dose limiting toxicities (DLTs), AEs, serious AEs (SAEs)
To assess the safety and tolerability of JMKX005425.
Time frame: up to 2 years
maximum plasma concentration (Cmax)
Maximum observed concentration.
Time frame: Up to 2 months
maximum plasma concentration (Tmax)
Time to reach maximum observed plasma concentration.
Time frame: Up to 2 months
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 2 years
Disease Control Rate (DCR)
DCR is the percentage of patients with a best overall response of CR or PR or Stable Disease (SD) per RECIST v1.1.
Time frame: Up to 2 years
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