HS-10502 is a PARP1-specific selective inhibitor. The purpose if this study is to assess the safety, tolerability, pharmacokinetics (PK), and efficacy of HS-10502 Combination Treatment in subjects with advanced solid tumors.
Males or females aged 18 years or older (≥18 years).
Patients diagnosed with pathologically confirmed advanced solid tumors.
Subjects have at least one target lesion as assessed per the RECIST 1.1.
Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 to 1 and no deterioration within 2 weeks before the first dose.
Have received or is currently receiving the following treatment: PARPi/B7-H4/B7-H3-targeted therapies;
Have received or is currently receiving the following treatment: PARPi/B7-H4/B7-H3-targeted therapies;
Have received any of cytotoxic chemotherapy drugs, investigational drugs, anti-tumor traditional Chinese medicines or other anti-tumor drugs within 14 days prior to the first dose of study drug; or need to continue these drugs during the study.
Presence of Grade ≥ 2 toxicities as per Common Terminology Criteria for Adverse Events due to prior anti-tumor therapy.
Single group
HS-10502 + NHA
DrugHS-10502 + NHA
HS-10502 + HS-20093
DrugHS-10502 + HS-20093
HS-10502+ Apatinib
DrugHS-10502+ Apatinib
HS-10502 + HS-20089
DrugHS-10502 + HS-20089
HS-10502 + Platinum + Bevacizumab
DrugHS-10502 + Platinum + Bevacizumab
HS-10502 + nab-paclitaxel or Docetaxel or Irinotecan
DrugHS-10502 + nab-paclitaxel or Docetaxel or Irinotecan
HS-10502 + Bevacizumab
DrugHS-10502 + Bevacizumab
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Treatment groupsSee each treatment group below.
Maximum tolerated dose (MTD) of HS-10502（Stage 1：Dose escalating stage）
MTD is defined as the previous dose level at which 2 or more out of 2-6 subjects experienced a DLT.
Maximum applicable dose (MAD) of HS-10502（Stage 1：Dose escalating stage）
MAD is defined as follows: a) based on PK data, it is anticipated that at this dose level, the dose-exposure plateau has been reached, b) based on existing safety data, it is judged that dose escalation following this dose level will have a large safety risk or subject intolerance, or c) based on the PK-PD model, it suggested that the optimal target concentration of safety and efficacy has been explored.
Efficacy of HS-10502: Objective response rate (ORR)（Stage 2： Dose expansion stage）
ORR is defined as the proportion of participants with BOR of confirmed CR or confirmed PR per RECIST v1.1 (applicable for all solid tumors except prostate cancer) or per RECIST v1.1 and PCWG3 (for prostate cancer only).
Incidence and severity of treatment-emergent adverse events
Assessed by number and severity of adverse events as evaluated according to NCI CTCAE v5.0.
PK parameters: The maximum observed concentration (Cmax) of HS-10502
Defines as the maximum plasma drug concentration of HS-10502
PK parameters: time to Cmax (Tmax) of HS-10502
Time of maximum observed concentration of HS-10502.
PK parameters: area under the concentration-time curve from time 0 to time t of last measurable concentration (AUC0-t) of HS-10502.
Area under the curve from the time of dosing to the time of the last measurable (positive) concentration.
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