Antibody-drug Conjugate Information
General Information of This Antibody-drug Conjugate (ADC)
| ADC ID |
DRG0LCOWD
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| 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 | ||||
| Therapeutic Target |
Microtubule (MT)
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Target Info | ||||
| Linker Name |
Valine-Citrulline (BCN-valyl-citrulline
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Linker Info | ||||
| Conjugate Type |
Site-specific conjugation through the glycan remodeling and click chemistry at Asn297.
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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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| 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 |
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