This is a phase I, open-label, first-in-human study of CS08399, comprising two phases: dose escalation (including single-dose and multiple-dose) and cohort expansion. The primary objectives of this study are to evaluate the safety, tolerability and pharmacokinetic (PK) characteristics of CS08399 in participants with MTAP-deleted solid tumors and Lymphoma, and to recommended Phase 2 dose(s) (RP2D) of CS08399 in appropriate tumor(s).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
186
Oral tablet. Only one dose on C0D1 in single-dose period. Once or twice daily from C1D1 until disease progression, death, intolerable toxicity, loss to follow-up, withdrawal of informed consent, or the end of the trial, whichever occurs first, in multiple-dose period in both escalation and cohort expansion phases.
Fudan University Shanghai Cancer Center
Shanghai, China
incidence of dose-limiting toxicity (DLT)
Time frame: 34 days after, that is 6 days after single-dose and 28 days after first administration in multiple-dose
maximum tolerated dose (MTD)
Time frame: dose escalation part, up to approximately 2 year
incidence of adverse events (AEs)
Number of participants with AE(s)
Time frame: from first administration to 28 days after last administration or next anti-tumor therapy, whichever occurs first
Pharmacokinetic parameters: Time to Maximum Concentration (Tmax)
Time frame: during treatment, up to approximately 2 year
Pharmacokinetic parameters: Maximum Concentration (Cmax)
Time frame: during treatment, up to approximately 2 year
Pharmacokinetic parameters: Area Under the Concentration-time Curve(AUC)
Time frame: during treatment, up to approximately 2 year
Pharmacokinetic parameters: Trough Concentration (Ctrough)
Time frame: during treatment, up to approximately 2 years
Pharmacokinetic parameters: Accumulation Ratio (Rac)
Time frame: during treatment, up to approximately 2 years
Pharmacokinetic parameters: Elimination Half-life (t1/2)
Time frame: during treatment, up to approximately 2 years
Pharmacokinetic parameters: Clearance over Fractional Bioavailability (CL/F)
Time frame: during treatment, up to approximately 2 years
Pharmacokinetic parameters: Volume of Distribution at Steady State over Fractional Bioavailability (Vz/F)
Time frame: during treatment, up to approximately 2 years
Objective Response Rate (ORR)
Time frame: Up to approximately 4 years
Disease control rate (DCR)
Time frame: Up to approximately 4 years
Duration of Response (DOR)
Time frame: Up to approximately 4 years
Time to Progression (TTP)
Time frame: Up to approximately 4 years
Time to Response (TTR)
Time frame: Up to approximately 4 years
progression-free survival (PFS)
Time frame: Up to approximately 4 years
Overall Survival (OS)
Time frame: Up to approximately 4 years
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