Eligible patients (≥18 years) must have histologically confirmed advanced/metastatic solid tumors refractory to standard therapy, ≥1 measurable lesion (RECIST 1.1), ECOG 0-1, and ≥12-week life expectancy. Key exclusions include prior B7-H3 therapy, recent anticancer treatments (chemotherapy/radiation/monoclonal antibodies within 2-4 weeks), major surgery within 4 weeks, uncontrolled comorbidities, active infections (antibiotics within 2 weeks), pregnancy, or HS-20093 component hypersensitivity. Contraception is mandatory for fertile participants.

This phase I study consists of two stages: the dose-escalation stage (Ia) aims to determine the maximum tolerated dose (MTD) of intravenous HS-20093 in advanced solid tumor patients within the first 21-day cycle; the dose-expansion stage (Ib) evaluates investigator-assessed objective response rate (ORR) by RECIST 1.1 (confirmed CR/PR requiring ≥4-week interval imaging) from first dose until progression or withdrawal (24-month maximum).

Primary safety endpoints include AE incidence/severity (CTCAE v5.0) monitored from first dose to 90 days post-treatment. Pharmacokinetic parameters (Cmax, Tmax, T1/2, AUC0-t) and anti-drug antibodies (up to 90 days post-treatment) will be assessed during Cycle 1. Secondary efficacy measures include ORR (dose-escalation), duration of response (DOR), disease control rate (DCR; requiring ≥5-week SD confirmation), progression-free survival (PFS), and overall survival (OS; dose-expansion only), all evaluated per RECIST 1.1 over 24 months.

Eligible patients (≥18 years) must have histologically confirmed advanced/metastatic solid tumors refractory to standard therapy, ≥1 measurable lesion (RECIST 1.1), ECOG 0-1, and ≥12-week life expectancy. Key exclusions include prior B7-H3 therapy, recent anticancer treatments (chemotherapy/radiation/monoclonal antibodies within 2-4 weeks), major surgery within 4 weeks, uncontrolled comorbidities, active infections (antibiotics within 2 weeks), pregnancy, or HS-20093 component hypersensitivity. Contraception is mandatory for fertile participants.

This phase I study consists of two stages: the dose-escalation stage (Ia) aims to determine the maximum tolerated dose (MTD) of intravenous HS-20093 in advanced solid tumor patients within the first 21-day cycle; the dose-expansion stage (Ib) evaluates investigator-assessed objective response rate (ORR) by RECIST 1.1 (confirmed CR/PR requiring ≥4-week interval imaging) from first dose until progression or withdrawal (24-month maximum).

Primary safety endpoints include AE incidence/severity (CTCAE v5.0) monitored from first dose to 90 days post-treatment. Pharmacokinetic parameters (Cmax, Tmax, T1/2, AUC0-t) and anti-drug antibodies (up to 90 days post-treatment) will be assessed during Cycle 1. Secondary efficacy measures include ORR (dose-escalation), duration of response (DOR), disease control rate (DCR; requiring ≥5-week SD confirmation), progression-free survival (PFS), and overall survival (OS; dose-expansion only), all evaluated per RECIST 1.1 over 24 months.

Eligible patients (≥18 years) must have metastatic sarcomas refractory to first-line therapy, ≥1 measurable lesion (RECIST 1.1), ECOG 0-1, and ≥12-week life expectancy. Key exclusions include prior B7-H3 therapy, recent cancer treatments (chemotherapy/radiotherapy/antibodies within 2-4 weeks), uncontrolled metastases/comorbidities, Grade >2 toxicities (except alopecia/neurotoxicity), active infections (HBV/HCV/HIV), CYP3A4-modifying drugs, or conditions compromising safety. Fertile participants must use contraception; pregnancy is prohibited.

Safety assessments include AE incidence/severity (CTCAE v5.0) from first dose through 90 days post-treatment. PK parameters (Cmax, Tmax, T1/2, AUC0-t) will be measured during Cycle 1 (21-day cycle). Immunogenicity will assess anti-drug antibodies up to 90 days post-treatment. Secondary efficacy endpoints include IRC-confirmed ORR, duration of response (DOR), disease control rate (DCR), progression-free survival (PFS), 4-month PFS rate, and overall survival (OS) over 24 months.

Eligible patients (≥18 years) must have histologically confirmed advanced/metastatic solid tumors refractory to standard therapy, ≥1 measurable lesion (RECIST 1.1), ECOG 0-1, and ≥12-week life expectancy. Key exclusions include prior B7-H3 therapy, recent anticancer treatments (chemotherapy/radiation/monoclonal antibodies within 2-4 weeks), major surgery within 4 weeks, uncontrolled comorbidities, active infections (antibiotics within 2 weeks), pregnancy, or HS-20093 component hypersensitivity. Contraception is mandatory for fertile participants.

This phase I study consists of two stages: the dose-escalation stage (Ia) aims to determine the maximum tolerated dose (MTD) of intravenous HS-20093 in advanced solid tumor patients within the first 21-day cycle; the dose-expansion stage (Ib) evaluates investigator-assessed objective response rate (ORR) by RECIST 1.1 (confirmed CR/PR requiring ≥4-week interval imaging) from first dose until progression or withdrawal (24-month maximum).

Primary safety endpoints include AE incidence/severity (CTCAE v5.0) monitored from first dose to 90 days post-treatment. Pharmacokinetic parameters (Cmax, Tmax, T1/2, AUC0-t) and anti-drug antibodies (up to 90 days post-treatment) will be assessed during Cycle 1. Secondary efficacy measures include ORR (dose-escalation), duration of response (DOR), disease control rate (DCR; requiring ≥5-week SD confirmation), progression-free survival (PFS), and overall survival (OS; dose-expansion only), all evaluated per RECIST 1.1 over 24 months.

Eligible patients (≥18 years) must have metastatic sarcomas refractory to first-line therapy, ≥1 measurable lesion (RECIST 1.1), ECOG 0-1, and ≥12-week life expectancy. Key exclusions include prior B7-H3 therapy, recent cancer treatments (chemotherapy/radiotherapy/antibodies within 2-4 weeks), uncontrolled metastases/comorbidities, Grade >2 toxicities (except alopecia/neurotoxicity), active infections (HBV/HCV/HIV), CYP3A4-modifying drugs, or conditions compromising safety. Fertile participants must use contraception; pregnancy is prohibited.

Safety assessments include AE incidence/severity (CTCAE v5.0) from first dose through 90 days post-treatment. PK parameters (Cmax, Tmax, T1/2, AUC0-t) will be measured during Cycle 1 (21-day cycle). Immunogenicity will assess anti-drug antibodies up to 90 days post-treatment. Secondary efficacy endpoints include IRC-confirmed ORR, duration of response (DOR), disease control rate (DCR), progression-free survival (PFS), 4-month PFS rate, and overall survival (OS) over 24 months.

Key exclusions include untreated CNS metastases, recent major surgery, strong CYP3A4 modulators, QT-prolonging drugs, uncontrolled comorbidities (diabetes, hypertension), or immunosuppressive conditions. Vaccination within 4 weeks or hypersensitivity to HS-20093 components also disqualify participants. Compliance and investigator-assessed safety risks are additional exclusion factors.

Pharmacokinetic parameters (Cmax, Tmax, T1/2, AUC0-t) and immunogenicity (ADA) are analyzed over 24 months. Patients must have measurable lesions (RECIST 1.1), ECOG 0-1, and life expectancy ≥12 weeks. Prior B7-H3/ADC therapy, recent cytotoxic/radiotherapy, uncontrolled metastases, cardiovascular risks, active infections, or unresolved toxicities (>Grade 2) are exclusions.

Eligible patients (18-75 years) must have histologically confirmed metastatic solid tumors, ≥1 measurable lesion (RECIST v1.1), ECOG 0-1, and life expectancy >12 weeks. Exclusions include prior MET/EGFR-targeted therapy, recent anticancer treatments (cytotoxics/TKIs within 2 weeks; investigational drugs/ADCs within 4 weeks), uncontrolled metastases, cardiovascular diseases, Grade ≥2 unresolved toxicities, or active infections.

The safety and tolerability of HS-20117 combination therapy are evaluated by monitoring treatment-emergent AEs (graded per NCI CTCAE v5.0) from the first dose to 90 days post-treatment. The MTD/MAD is determined within 21 days, with MTD defined as the highest dose where ≤1/6 patients experience DLT and MAD based on PK/PD, safety, or exposure plateau.

Eligible patients (≥18 years) have recurrent/metastatic HNSCC or solid tumors refractory to standard therapy, ≥1 measurable lesion (RECIST 1.1), ECOG 0-1, and life expectancy ≥12 weeks. Key exclusions include prior B7-H3 therapy, recent anticancer treatments (cytotoxics within 14 days; macromolecular agents within 28 days), uncontrolled metastases, Grade ≥2 toxicities, active infections (HBV/HCV/HIV), cardiovascular risks, or steroid dependence. Vaccination within 4 weeks or HS-20093 hypersensitivity also preclude enrollment.

Eligible patients (≥18 years) must have untreated ES-SCLC with ≥1 measurable lesion (RECIST 1.1), ECOG 0-1, and life expectancy ≥12 weeks. Key exclusions include prior B7-H3 therapy, recent radiotherapy/surgery (within 4 weeks), uncontrolled effusions, symptomatic CNS metastases, Grade ≥2 unresolved toxicities, active infections (HBV/HCV/HIV), cardiovascular risks, or concurrent CYP3A4/QT-prolonging drugs. Conditions compromising safety or protocol compliance per investigator judgement also disqualify participants.

The primary efficacy endpoint is ORR (confirmed CR/PR requiring ≥4-week confirmation per RECIST 1.1), assessed by investigators over 18 months. Secondary endpoints include DCR (CR+PR+SD), DoR (time from initial response to progression/death), PFS (time to progression/death), and OS (time to death), all evaluated through imaging comparison to baseline tumor burden during the 18-month study period.

Safety assessments monitor AEs (graded by CTCAE v5.0) until 90 days post-treatment. PK analysis includes Cmax, Tmax, T1/2 and AUC0-t measured during Cycle 1 (21 days), alongside immunogenicity (ADA detection). Objective tumor responses are tracked via serial imaging relative to baseline measurements, with SD requiring ≥5 weeks of stability after treatment initiation.

Eligible patients (≥18 years) must have confirmed SCLC that progressed after first-line platinum therapy, ≥1 measurable lesion (RECIST 1.1), ECOG 0-1, and >12-week life expectancy. Critical exclusions include: combined SCLC history, ≤30-day chemotherapy-free interval, prior B7-H3/topotecan treatment, untreated brain metastases, unresolved toxicities (>CTCAE grade 1), significant cardiorespiratory diseases, active infections, or conditions compromising protocol compliance. Fertile patients must use contraception, with pregnancy/breastfeeding excluded.

The primary efficacy endpoint is overall survival (OS), measured from randomization to death from any cause over approximately 4.5 years. Key secondary endpoints include confirmed objective response rate (ORR, CR+PR), disease control rate (DCR, CR+PR+SD), duration of response (DoR), and progression-free survival (PFS), all assessed by blinded independent central review and investigators per RECIST v1.1 through the same 4.5-year timeframe.

Safety evaluations focus on treatment-emergent adverse events (TEAEs) graded by NCI CTCAE v5.0, monitored from first dose through safety follow-up (approximately 4.5 years). Tumor response assessments include: ORR requiring confirmation (CR/PR), DCR (including SD/non-CR/non-PD), DoR (first response until progression/death), and PFS (randomization to progression/death), with imaging conducted at protocol-specified intervals.

Eligible patients (≥18 years) must have non-progressed limited-stage SCLC after chemoradiotherapy, ECOG 0-1, and >12-week life expectancy. Key exclusions include: mixed histology/extensive-stage disease, progression during CRT, prior B7-H3 therapy, major surgery within 4 weeks, active ILD/pneumonitis, uncontrolled comorbidities (cardiovascular/diabetic/hypertensive disorders), recent thrombosis/serious bleeding/infections, or conditions compromising safety per investigator assessment. Fertility requirements and pregnancy restrictions apply.

The primary endpoints assess the efficacy of HS-20093 versus active surveillance, with progression-free survival (PFS) measured from randomization to disease progression or death (whichever occurs first) by Independent Review Committee (IRC) per RECIST v1.1 over approximately 6 years. Overall survival (OS), the second primary endpoint, is defined as time from randomization to death from any cause during the same 6-year period.

Secondary efficacy assessments include PFS at 12/18 months (PFS12/PFS18), objective response rate (ORR, CR+PR), disease control rate (DCR, CR+PR+SD), and duration of response (DoR) - all evaluated by both IRC and investigators per RECIST v1.1 through 6 years. Additional measures include 24/36-month survival rates (OS24/OS36) and treatment-emergent adverse events (graded by NCI CTCAE v5.0) monitored until 90 days post-treatment.

Eligible patients (≥18 years) must have advanced solid tumors, ≥1 measurable lesion (RECIST 1.1), ECOG 0-1, and ≥12-week life expectancy. Key exclusions include prior PARPi/B7-H4/B7-H3 therapy, uncontrolled comorbidities (cardiovascular, diabetic, hypertensive), active infections (HBV/HCV/HIV), Grade ≥2 toxicities, pleural/abdominal effusion requiring intervention, brain metastasis, or conditions affecting safety/compliance. Fertile participants must use contraception; pregnancy/breastfeeding is prohibited. Live vaccines within 4 weeks or active autoimmune diseases are exclusionary.

The study aims to determine the maximum tolerated dose (MTD) and maximum applicable dose (MAD) of HS-10502 during dose escalation (Stage 1), with MTD defined as the dose where ≥2/2-6 subjects experience dose-limiting toxicities (DLTs) in Cycle 1 (21 days). MAD considers PK exposure plateau, safety risks, and optimal PK-PD target concentration. In Stage 2 (dose expansion), primary efficacy is measured by objective response rate (ORR), assessing confirmed CR/PR per RECIST v1.1 (solid tumors) or RECIST v1.1+PCWG3 (prostate cancer) over ~2 years.

Safety is evaluated via treatment-emergent adverse events (NCI CTCAE v5.0) from Cycle 1 Day 1 to 28 days post-treatment. PK parameters include Cmax, Tmax, AUC0-t (Cycle 1), and steady-state metrics (Css,max, Tss,max, Css,min, AUCss; Cycle 2). Secondary efficacy endpoints span ORR, disease control rate (DCR: CR+PR+SD≥5 weeks), duration of response (DoR), PFS (all solid tumors except prostate), rPFS (prostate, RECIST v1.1+PCWG3), OS (~4 years), and tumor-specific measures: CA-125 reduction ≥50% (ovarian) and PSA50 response/time to PSA progression (prostate

Eligible subjects (≥18 years) must have histologically confirmed advanced solid tumors, ≥1 measurable lesion (RECIST 1.1), ECOG 0-1, and ≥12-week life expectancy. Key exclusions: prior B7-H3 therapy, recent chemotherapy/radiotherapy (within 2-4 weeks), untreated metastases/effusions, major surgery within 4 weeks, Grade >2 toxicities, uncontrolled comorbidities (cardiovascular/diabetes/hypertension), active infections (HBV/HCV/HIV), or CYP3A4/CYP2D6-modifying drugs. Fertile participants require contraception; pregnancy/breastfeeding is prohibited. Conditions compromising safety or compliance per investigator judgment are exclusionary.

Safety analysis includes AE incidence/severity (NCI CTCAE v5.0) from first dose to 90 days post-treatment. PK parameters (Cmax, Tmax, T1/2, AUC0-t) are evaluated during Cycle 1 (21-day cycles). Immunogenicity assesses anti-drug antibodies (ADAs) up to 90 days post-treatment. Secondary efficacy measures include IRC-confirmed ORR, duration of response (DoR), disease control rate (DCR: CR+PR+SD≥5 weeks), progression-free survival (PFS), radiographic PFS (rPFS for mCRPC), and overall survival (OS) over 24 months. Prostate cancer cohorts add PSA-specific endpoints: response rate (≥50% decline) and time to PSA progression.

Eligible patients (≥18 years) must have confirmed metastatic sarcoma (Cohort 1: soft tissue; Cohort 2: osteosarcoma) with ≥1 measurable lesion (RECIST 1.1), ECOG 0-1, and ≥12-week life expectancy. Key exclusions include prior B7-H3/TOP1i treatment (cohort-specific), recent anticancer therapies (chemotherapy/radiotherapy/antibodies within 2-4 weeks), major surgery within 4 weeks, uncontrolled comorbidities, active infections, or pregnancy. Fertile participants must use contraception throughout the study.

Key efficacy outcomes include investigator-assessed objective response rate (ORR), disease control rate (DCR), duration of response (DoR), progression-free survival (PFS), and overall survival (OS) over 24 months. Pharmacokinetic parameters (Cmax, Tmax, T1/2, AUC0-t) and anti-drug antibody (ADA) levels will be monitored from first dose through study completion. Confirmed tumor responses require ≥1 repeat imaging (≥4 weeks for CR/PR, ≥5 weeks for SD).

Eligible patients (≥18 years) must have histologically confirmed advanced/metastatic solid tumors (including esophageal carcinoma) with ≥1 measurable lesion (RECIST 1.1), ECOG 0-1, and >12-week life expectancy. Key exclusions: prior B7-H3 therapy; recent anticancer treatments (chemotherapy/radiation/MAbs within 2-4 weeks); major surgery within 4 weeks; significant esophageal tumor invasion (aorta/trachea); active infections (e.g., hepatitis B/C); pregnancy; or HS-20093 hypersensitivity. Contraception is mandatory.

Secondary endpoints include duration of response (DOR), disease control rate (DCR; CR/PR/SD requiring ≥5-week assessment), progression-free survival (PFS), and overall survival (OS). Safety evaluates AE incidence/severity (CTCAE v5.0) from first dose to 90 days post-treatment, while pharmacokinetics and anti-drug antibody (ADA) incidence are monitored from Cycle 1 Day 1 through 90 days post-treatment.

Eligible patients (≥18 years) must have confirmed advanced/metastatic solid tumors, ECOG 0-1, ≥1 measurable lesion (RECIST 1.1), and ≥12-week life expectancy. Dose escalation includes treatment-refractory cases; dose expansion prioritizes treatment-naïve patients. Exclusions: prior B7-H3 therapy; intolerance to PD-L1 inhibitors/cisplatin/enzalutamide/cetuximab; recent anticancer treatments (chemotherapy/radiation/MAbs/surgery within 2-4 weeks); uncontrolled comorbidities; active infections; or pregnancy. Contraception is mandatory.

Key endpoints include safety (AE incidence/severity per CTCAE v5.0 through 90 days post-treatment) and efficacy measures: ORR, DCR, DOR, PFS, and OS per RECIST 1.1 (PCWG3 for prostate cancer). Prostate-specific endpoints include rPFS, TTPP, PSA response rate (≥50% decline), and TFST. Pharmacokinetics (Cmax, Tmax, T1/2, AUC0-t) and ADA incidence are monitored from first dose to study completion (24 months).