This is a Phase I, multicenter, open-label clinical trial with dose escalation/dose expansion phases, designed to evaluate the safety, tolerability, pharmacokinetic/pharmacodynamic (PK/PD) profiles, and antitumor efficacy characteristics of HS-10587 in patients with MTAP-deleted advanced solid tumors.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
362
HS-10587 tablet
Incidence of DLT
dose-limiting toxicities
Time frame: Up to 21 days after the first administration. (first cycle)
MTD or MAD
maximum tolerated dose (MTD) or maximum applicable dose (MAD)
Time frame: Up to 21 days after the first administration. (first cycle)
Incidence of adverse events (AEs) and serious adverse events (SAEs)
Number of participants with AEs and SAEs
Time frame: From time of informed consent to 28 days post last dose of HS-10587.
Pharmacokinetics (PK) profile of HS-10587 in patients with advanced solid tumors
Maximum concentration (Cmax).
Time frame: Predose and postdose up to end of treatment, approximately 2 years
Pharmacokinetics (PK) profile of HS-10587 in patients with advanced solid tumors
Time of maximum concentration (Tmax).
Time frame: Predose and postdose up to end of treatment, approximately 2 years.
Pharmacokinetics (PK) profile of HS-10587 in patients with advanced solid tumors
area under the plasma concentration-time curve from time 0 to time t of the last measurable concentration (AUC0-t)
Time frame: Predose and postdose up to end of treatment, approximately 2 years.
Pharmacokinetics (PK) profile of HS-10587 in patients with advanced solid tumors
Area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUC0-∞)
Time frame: Predose and postdose up to end of treatment, approximately 2 years
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Efficacy of HS-10587 in patients with advanced solid tumors
Objective response rate (ORR) evaluated as per RECIST v1.1
Time frame: Predose and post dose up to end of treatment, approximately 2 years
Efficacy of HS-10587 in patients with advanced solid tumors.
Duration of response (DOR) evaluated as per RECIST v1.1
Time frame: Predose and post dose up to end of treatment, approximately 2 years.
Efficacy of HS-10587 in patients with advanced solid tumors.
Disease control rate (DCR) evaluated as per RECIST v1.1
Time frame: Predose and post dose up to end of treatment, approximately 2 years
Efficacy of HS-10587 in patients with advanced solid tumors.
Time to response (TTR) evaluated as per RECIST v1.1
Time frame: Predose and post dose up to end of treatment, approximately 2 years.
Efficacy of HS-10587 in patients with advanced solid tumors.
Progression-free survival (PFS) evaluated as per RECIST v1.1
Time frame: Predose and post dose up to end of treatment, approximately 2 years.
Efficacy of HS-10587 in patients with advanced solid tumors.
Overall survival (OS) evaluated as per RECIST v1.1
Time frame: Predose and post dose up to end of treatment, approximately 2 years