The goal of this clinical trial is to study ISM8207 in participants with advanced solid tumors and relapsed/refractory B-cell lymphoma. The primary objective is to evaluate the safety and tolerability of ISM8207 orally administered in participants with advanced solid tumors and relapsed/refractory B-cell lymphoma
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Pharmaceutical formulation: Capsules Mode of Administration: Oral
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
RECRUITINGShanghai Jiao Tong University School of Medicine-Ruijin Hospital
Shanghai, Shanghai Municipality, China
RECRUITINGIncidence of dose-limiting toxicity (DLT) events
Time frame: 31 days
Incidence and severity of adverse events (AEs)
Time frame: Approximately 2 years
Recommended phase 2 dose (RP2D)
Time frame: 31 days
objective response rate (ORR)
Time frame: Approximately 2 years
best objective response (BOR)
Time frame: Approximately 2 years
duration of response (DoR)
Time frame: Approximately 2 years
disease control rate (DCR)
Time frame: Approximately 2 years
progression-free survival (PFS)
Time frame: Approximately 2 years
6-month overall survival (OS) rates
Time frame: Approximately 2 years
1-year overall survival (OS) rates
Time frame: Approximately 2 years
maximum observed concentration (Cmax)
Time frame: Approximately 2 years
time of maximum observed concentration (Tmax)
Time frame: Approximately 2 years
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area under the concentration-time curve (AUC)
Time frame: Approximately 2 years
terminal half-life (t1/2)
Time frame: Approximately 2 years
apparent clearance (CL/F)
Time frame: Approximately 2 years
apparent volume of distribution (Vz/F)
Time frame: Approximately 2 years
maximum observed concentration at steady state (Css,max)
Time frame: Approximately 2 years
minimum observed concentration at steady state (Css,min)
Time frame: Approximately 2 years
average concentration at steady state (Css,av)
Time frame: Approximately 2 years
time of Css,max (Tss,max)
Time frame: Approximately 2 years
AUC from time 0 to time dosing interval (AUCss,0-tau)
Time frame: Approximately 2 years
CLss/Fss
Time frame: Approximately 2 years
Vz/Fss
Time frame: Approximately 2 years
accumulation ratio of Cmax (RCmax) after multiple doses
Time frame: Approximately 2 years
accumulation ratio of AUC (RAUC) after multiple doses
Time frame: Approximately 2 years