Antibody-drug Conjugate Information
General Information of This Antibody-drug Conjugate (ADC)
| ADC ID |
DRG0YNOYQ
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| ADC Name |
HLX42
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| Synonyms |
HLX42; HLXD42; YL221
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| Organization |
Shanghai Henlius Biotech (Originator);MediLink Therapeutics
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| Drug Status |
Phase 1
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| Drug-to-Antibody Ratio |
8
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| Antibody Name |
Anti-EGFR IgG1 mAb
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Antibody Info | ||||
| Antigen Name |
Epidermal growth factor receptor (EGFR)
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Antigen Info | ||||
| 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 |
Undisclosed
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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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| Lung 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 |
Eligible participants (18-75 years) must have confirmed advanced/metastatic solid tumors, measurable lesions per RECIST 1.1, ECOG 0-1, and adequate organ function. Exclusions include recent malignancies, uncontrolled ILD, allergies to study drug components, active infections, poorly managed cardiovascular issues, immunosuppressive therapy, or hepatic dysfunction (except Child-Pugh A in HCC). Pregnant/nursing women or those deemed unsuitable by investigators are excluded.
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| Administration Dosage |
Patients with good tolerability and well controlled disease will receive the treatment once every 3 weeks (Q3W), until progressive disease (PD) without any clinical benefit, initiation of other anti-tumor therapies, death, intolerable toxicity, or withdraw the informed consent (whichever occurs first).
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| Related Clinical Trial | |||||
| NCT Number | NCT06210815 | Clinical Status | PHASE1 | ||
| Clinical Description | A Phase I Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetic Characteristics of HLX42 (Anti-EGFR ADC) in Patients With Advanced/Metastatic Solid Tumors | ||||
| Primary Endpoint |
The study evaluates HLX42's Dose-Limiting Toxicity (DLT) and Maximum Tolerated Dose (MTD) within 21 days post-first administration. DLT includes drug-related AEs impacting dose escalation, while MTD is the highest dose where ≤1 of 6 patients experience DLT.
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| Other Endpoint |
Primary and secondary endpoints include Objective Response Rate (ORR), Duration of Response (DOR), Progression-Free Survival (PFS), and Overall Survival (OS) over approximately 24 months. Pharmacokinetic measures (Cmax, Tmax, T1/2) are assessed within 21 days, alongside immune responses (ADA, Nab incidence/titer). Treatment-emergent adverse events are monitored until 90 days post-last dose.
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