Key inclusion: Adults ≥18 with histologically/cytologically confirmed advanced solid tumors (≥1 RECIST 1.1 measurable lesion: ≥10mm for non-nodal/≥15mm for nodal lesions), ECOG 0-1, life expectancy >12 weeks, contraception compliance, and signed informed consent. Standard treatment must be ineffective/unavailable/intolerable.

HS-20089 for IV infusion of various dose strengths administered in 21 day dosing cycles.

A Phase I, Open-label, Multicenter Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Efficacy of HS-20089 in Patients With Advanced Solid Tumors

Primary endpoint is MTD determination of HS-20089 in advanced solid tumor patients within 3 weeks of treatment initiation, with safety monitoring through CTCAE criteria until 90 days post-last dose.

Secondary endpoints include PK profiling (Cmax/t1/2/AUC0-24/AUC0-t/AUC0-∞ post-single dose; Cmax ss in 21-day cycles), immunogenicity (ADA development), and efficacy evaluation (confirmed ORR per RECIST 1.1 with ≥4-week validation, tracked up to 2 years).

Key inclusion: Adults ≥18 with recurrent/metastatic solid tumors (ovarian/endometrial focus), ≥1 measurable lesion (non-CNS/bone-only), mandatory tumor tissue, ECOG 0-1, ≥12-week life expectancy, contraception until 6mo post-treatment, and protocol compliance.

Patients in cohort 1 of phase 2a will be randomly assigned to receive HS-20089 at 4.8 mg/kg or 5.8 mg/kg; Patients in cohort 2/3/4 of phase 2a will receive HS-20089 at 5.8 mg/kg; Patients of phase 2b will receive HS-20089 at recommended dose..

A Phase 2 Study of HS-20089 for Injection in Patients With Recurrent or Metastatic Ovarian Cancer and Endometrial Cancer

Primary endpoints include investigator-assessed ORR per RECIST 1.1 (confirmed CR/PR) and GCIG CA-125 criteria for ovarian cancer, with safety monitoring of AEs (CTCAE v5.0) until 90 days post-treatment.

Secondary endpoints cover IRC-confirmed efficacy (ORR/DCR/DoR/PFS/OS), PK parameters (Cmax/Tmax/AUC), ADA development, and ovarian cancer-specific CA-125 response in evaluable patients (baseline ≥2×ULN).

Key inclusion: Women ≥18 with platinum-resistant epithelial ovarian/primary peritoneal/fallopian tube cancer, ≥1 measurable lesion (RECIST 1.1), ECOG 0-1, life expectancy >12 weeks, tumor tissue availability, adequate organ function, and contraception compliance.

A Multi-center, Randomized, Open-label, Controlled, Phase III Clinical Study Evaluating HS-20089 vs. Investigator's Choice of Chemotherapy in the Treatment of Platinum-resistant Recurrent Epithelial Ovarian Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer

Primary endpoint is BIRC-assessed PFS per RECIST 1.1 from screening to study completion (average 1 year).

Secondary endpoints include OS, investigator/BIRC-assessed ORR/DoR/DCR per RECIST 1.1, and AE monitoring, all evaluated from screening to study completion (average 1 year).

Key inclusion: Adults ≥18 with advanced solid tumors (RECIST 1.1 measurable lesions), ECOG 0-1, life expectancy ≥12 weeks, contraception compliance, negative pregnancy test (HCG-confirmed if needed), and voluntary informed consent.

A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of HS-10502 Combination Treatment in Subjects with Advanced Solid Tumors

Primary endpoints include MTD/MAD determination in dose escalation (Cycle 1, 21 days) and ORR assessment in dose expansion (RECIST v1.1/PCWG3 for prostate cancer, RECIST v1.1+GCIG CA-125 for ovarian cancer) over 2 years.

Secondary endpoints cover safety (CTCAE v5.0), PK parameters (Cmax/Tmax/AUC0-t in Cycle 1; Css,max/Tss,max/Css,min/AUCss in Cycle 2), and efficacy measures (DCR/DoR/PFS/rPFS/OS over 2-4 years) with tumor-specific assessments (CA-50% reduction for ovarian cancer, PSA50/time-to-PSA-progression for prostate cancer).

Key inclusion: Adults ≥18 with histologically-confirmed advanced solid tumors (≥1 RECIST 1.1 measurable non-CNS/bone lesion), mandatory tumor tissue submission, ECOG 0-1, life expectancy ≥12 weeks, contraception compliance, negative pregnancy test (HCG-confirmed if needed), and voluntary informed consent.

A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of HS-20089 Combination Treatment in Subjects With Advanced Solid Tumors

Primary objective is to determine MTD/MAD of HS-20089 combination therapy within 21 days of first dose, with safety monitoring via CTCAE v5.0 until 90 days post-treatment.

Secondary objectives include PK analysis (Cmax/Tmax/AUC0-t/AUC0-∞ in Cycle 1), immunogenicity (ADA detection), and efficacy evaluation (investigator-assessed ORR/DCR/DoR/PFS per RECIST 1.1 and OS, all tracked up to 24 months).

A phase 1, open-label, multicenter study to evaluate safety, tolerability, pharmacokinetics, and efficacy of HS-20089 in patients with advanced solid tumors.