Antibody-drug Conjugate Information
General Information of This Antibody-drug Conjugate (ID: DRG0YNOYQ)
| 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 | ||||
| Payload 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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2027 Update
The disease landscape of This ADC
2027 Update
The clinical trial pipelines of This ADC
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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