Antibody-drug Conjugate Information
General Information of This Antibody-drug Conjugate (ADC)
| ADC ID |
DRG0YMRIE
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| ADC Name |
JSKN-016
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| Synonyms |
JSKN-016; JSKN016
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| Organization |
Alphamab Oncology (Originator)
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| Drug Status |
Phase 3
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| Drug-to-Antibody Ratio |
4
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| Antibody Name |
Anti-HER3/TROP2 bsAb
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Antibody Info | Antigen Name | |||
| Payload Name |
TOP1 inhibitor
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Payload Info | ||||
| Therapeutic Target |
DNA topoisomerase 1 (TOP1)
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Target Info | ||||
| Linker Name |
A cleavable linker
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Linker Info | ||||
| Conjugate Type |
Enzymatic Catalysis
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The indication landscape of This ADC(2027 Update)
The clinical trial pipeline of This ADC(2027 Update)
| Indication | Phase 1 | Phase 1/2 | Phase 2 | Phase 2/3 | Phase 3 | New Drug Application | Approved | ||||
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| Breast cancer |
1 Trials
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1 Trials
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| Gastric cancer |
1 Trials
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| Gastroesophageal junction adenocarcinoma |
1 Trials
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| Lung cancer |
1 Trials
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1 Trials
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| Oesophageal cancer |
1 Trials
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| Unspecific solid tumor |
1 Trials
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General Information of The Activity Data Related to This ADC
Identified from the Human Clinical Data
Full List of Activity Data of This Antibody-drug Conjugate
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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| Administration Dosage |
.
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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 | ||||
| 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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| Administration Dosage |
.
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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 | ||||
| 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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| Administration Dosage |
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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 | ||||
| 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