Antibody-drug Conjugate Information
General Information of This Antibody-drug Conjugate (ADC)
| ADC ID |
DRG0JSPJR
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| ADC Name |
ZL-1310
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| Synonyms |
YL 212; YL-212; YL212; ZL-1310; ZL 1310; ZL1310
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| Organization |
Suzhou Medilink Therapeutics Ltd.; Zai Lab Ltd.
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| Drug Status |
Phase 1
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| Drug-to-Antibody Ratio |
8
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| Antibody Name |
Undisclosed
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| Antigen Name |
Delta-like protein 3 (DLL3)
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Antigen Info | ||||
| Payload Name |
YL0010014
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Payload Info | ||||
| Therapeutic Target |
DNA topoisomerase 1 (TOP1)
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Target Info | ||||
| Linker Name |
Tumor microenviroment activable tripeptide linker
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Linker Info | ||||
| Combination Type |
B81
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General Information of The Activity Data Related to This ADC
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 |
Eligible participants must provide informed consent, have histologically confirmed extensive-stage SCLC progressing after platinum therapy (≤3 prior metastatic regimens), be ≥18 years with ECOG 0-1, possess ≥1 RECIST-measurable lesion, provide tumor tissue (fresh or archived), and demonstrate >3 month life expectancy. Prior therapies must meet specified washout periods before enrollment.
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| Administration Dosage |
Dose level 1 of ZL-1310 established from single-agent dose-escalation
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| Related Clinical Trial | |||||
| NCT Number | NCT06179069 | Clinical Status | PHASE1 | ||
| Clinical Description | An Open-label, Multicenter Study of ZL-1310 to Evaluate the Safety, Tolerability, and Pharmacokinetics in Subjects With Small Cell Lung Cancer | ||||
| Primary Endpoint |
Safety endpoints include incidence of Dose Limiting Toxicities (DLTs), Treatment-Emergent Adverse Events (TEAEs), and Serious Adverse Events (SAEs) for ZL-1310 as monotherapy and in combination with atezolizumab ± carboplatin, all assessed over 24 months. DLTs will be evaluated separately for each treatment regimen (monotherapy, doublet, and triplet combinations), with corresponding counts of affected subjects recorded for each safety parameter.
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| Other Endpoint |
Efficacy measures comprise ORR, DOR, PFS, DCR (all per RECIST 1.1), and OS for all three treatment regimens (monotherapy, doublet, triplet), evaluated over 24 months. Pharmacokinetic analyses include total antibody and unconjugated payload measurements for each treatment combination, with assessments continuing through the 24-month study period.
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