Antibody Information
General Information of This Antibody (ID: ANTI0VPGYS)
| Antibody Name | Anti-HER3/TROP2 bsAb |
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| Antigen Name | HER3; TROP2 |
Antigen Info | ||||
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Each Antibody-drug Conjugate Related to This Antibody
Full Information of The Activity Data of The ADC(s) Related to This Antibody
JSKN-016 [Phase 3]
Identified from the Human Clinical Data
| Experiment 1 Reporting the Activity Date of This ADC | [1] | ||||
| Patients Enrolled |
Key inclusion criteria: signed consent; age ≥18; ECOG 0-1; life expectancy ≥3 months; histologically confirmed advanced NSCLC (EGFRmut/negative) refractory to standard therapies; ≥1 measurable lesion (RECIST 1.1); available tumor tissue; adequate organ function; contraception agreement.
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| Related Clinical Trial | |||||
| NCT Number | NCT06775483 | Clinical Status | PHASE2 | ||
| Clinical Description |
Evaluation of JSKN016 in the Treatment of Advanced Non-small Cell Lung Cance: a Phase II Clinical Study
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| Primary Endpoint |
Primary endpoints include investigator-assessed ORR (CR+PR per RECIST v1.1) and AE incidence for safety evaluation, both measured over 24 months.
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| Other Endpoint |
Secondary endpoints comprise DOR, DCR, TTR, PFS (per RECIST v1.1), OS, PK parameters (Cmax, AUC, Tmax of JSKN016), and ADA incidence, all evaluated within 24 months.
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| Experiment 2 Reporting the Activity Date of This ADC | [2] | ||||
| Patients Enrolled |
Key inclusion criteria: signed consent; age 18-75; ECOG 0-1; life expectancy ≥3 months; histologically confirmed advanced NSCLC ineligible for curative treatment; ≥1 measurable lesion (RECIST 1.1); available tumor tissue; adequate organ function; contraception agreement.
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| Related Clinical Trial | |||||
| NCT Number | NCT06868732 | Clinical Status | PHASE1 | ||
| Clinical Description |
Evaluation of JSKN016 Combination Therapy in Subjects with Advanced Non-Small Cell Lung Cancer: a Phase Ib Study
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| Primary Endpoint |
Primary endpoints include investigator-assessed ORR (CR+PR per RECIST v1.1) and AE incidence for safety evaluation, both measured over 24 months.
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| Other Endpoint |
Secondary endpoints comprise efficacy measures (DOR, DCR, TTR, PFS, OS per RECIST v1.1), PK parameters (Cmax, Cmin of ADC components), and ADA assessment, all evaluated within 24 months.
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| Experiment 3 Reporting the Activity Date of This ADC | [3] | ||||
| Patients Enrolled |
Key inclusion criteria: signed consent; age ≥18; advanced/metastatic epithelial malignancies (AGA+ NSCLC/HER2 IHC0 BC) refractory to standard therapy; ≥1 measurable lesion (RECIST 1.1); ECOG 0-1; life expectancy ≥3 months; adequate organ function; LVEF ≥50%; contraception compliance; biomarker requirements (e.g., EGFR/ALK mutations for NSCLC).
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| Related Clinical Trial | |||||
| NCT Number | NCT06592417 | Clinical Status | PHASE1 | ||
| Clinical Description |
To Evaluate the Phase I Clinical Study of JSKN016 in Chinese Patients With Advanced Malignant Solid Tumors
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| Primary Endpoint |
Primary endpoints include DLT incidence (21-day post-first dose), safety profile (TEAE/TRAE/SAE incidence up to 30 days post-last dose), lab abnormalities, MTD/RP2D determination, and ORR assessment (RECIST v1.1) within 1 year post-last dose.
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| Other Endpoint |
Secondary endpoints comprise CBR (CR+PR+SD≥6 months), PK parameters (Cmax, Tmax, AUC, t1/2), and DOR evaluation, all measured within 1 year post-last dose or 90 days post-treatment.
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References