Antibody-drug Conjugate Information
General Information of This Antibody-drug Conjugate (ID: DRG0LCOWD)
| ADC Name |
MRG-004A
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| Synonyms |
MRG 004A; MRG-004A; MRG004A
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| Organization |
Shanghai Miracogen Inc.; Lepu Biopharma Co., Ltd.
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| Drug Status |
Phase 1/2
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| Drug-to-Antibody Ratio |
3.8
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| Antibody Name |
Undisclosed
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| Antigen Name |
Tissue factor (F3)
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Antigen Info | ||||
| Payload Name |
Monomethyl auristatin E
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Payload Info | ||||
| Payload Target |
Microtubule (MT)
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Target Info | ||||
| Linker Name |
Valine-Citrulline (BCN-valyl-citrulline; Protease-cleavable linker)
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Linker Info | ||||
| Conjugate Type |
Site-specific conjugation through the glycan remodeling and click chemistry at Asn297.
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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 |
Inclusion criteria include: age ≥18, life expectancy ≥6 months, informed consent, measurable disease by RECIST v1.1, ECOG 0-1, and adequate organ function. Part B requires Tissue Factor (TF)-positive tumors via IHC. Exclusions involve: TF-negative tumors (Part B), unresolved toxicities (>Grade 1), active CNS metastases, recent anticancer therapy (≤21 days), bleeding/cardiac risks, uncontrolled infections, pregnancy, HIV/hepatitis, strong CYP3A4 modifiers use, or conditions deemed unsafe by investigators. Prior radiotherapy toxicities must resolve to Grade ≤1.
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| Administration Dosage |
All patients in Part A (dose escalation) and Part B (dose expansion) will be administrated MRG004A on Day 1 of every 3 weeks (21-day cycle).
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| Related Clinical Trial | |||||
| NCT Number | NCT04843709 | Clinical Status | PHASE1|||PHASE2 | ||
| Clinical Description | An Open-Label, Multi-center, Phase I/II Dose Escalation and Expansion Study to Assess the Safety, Tolerability, Anti-Tumor Activity and Pharmacokinetics of MRG004A in Patients With Tissue Factor Positive Advanced or Metastatic Solid Tumors | ||||
| Primary Endpoint |
The primary endpoints for this study include determining the Maximum Tolerated Dose (MTD) (assessed within the first 21-day treatment cycle) as the highest dose where <33% of patients experience Dose-Limiting Toxicity (DLT), and establishing the Recommended Phase II Dose (RP2D) based on safety, efficacy, and PK data (evaluated over 24 months). Additional metrics are Objective Response Rate (ORR) (CR+PR rate by Independent Central Review) and Adverse Events (AEs) (recorded from informed consent until 45 days post-last dose), covering all trial-related side effects regardless of causality.
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| Other Endpoint |
Key secondary outcomes encompass efficacy measures: Duration of Response (DoR) (time from initial response to progression/death), Disease Control Rate (DCR) (CR+PR+SD≥6 weeks), Progression-Free Survival (PFS) (time to progression/death), and Overall Survival (OS) (time to death from any cause), all tracked for up to 24 months. Pharmacokinetic parameters (Cmax, Tmax, AUClast) and Anti-Drug Antibody (ADA) incidence are evaluated from baseline to 30 days post-treatment.
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References