Antibody-drug Conjugate Information

General Information of This Antibody-drug Conjugate (ADC)
ADC ID
DRG0RIPVI
ADC Name
MRG-003
Synonyms
MRG 003; MRG003
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Organization
Shanghai Miracogen Inc.; Lepu Biopharma Co., Ltd.
Drug Status
Phase 3
Indication
In total 9 Indication(s)
Head and neck squamous carcinoma [ICD11:2C31]
Phase 3
Biliary cancer [ICD11:2C17]
Phase 2
Biliary tract cancer [ICD11:2C15]
Phase 2
Colorectal cancer [ICD11:2B91]
Phase 2
Gastroesophageal junction cancer [ICD11:2B71]
Phase 2
Intrahepatic bile ducts cancer [ICD11:2C12]
Phase 2
Nasopharyngeal carcinoma [ICD11:2B6B]
Phase 2
Non-small cell lung cancer [ICD11:2C25]
Phase 2
Squamous cell cancer [ICD11:2D60-2D61]
Phase 2
Drug-to-Antibody Ratio
3.8
Structure
Antibody Name
JMT101
  Antibody Info 
Antigen Name
Epidermal growth factor receptor (EGFR)
  Antigen Info 
Payload Name
Monomethyl auristatin E
  Payload Info 
Therapeutic Target
Microtubule (MT)
  Target Info 
Linker Name
Mc-Val-Cit-PABC
  Linker Info 
Conjugate Type
Random conjugation through reduced inter-chain cysteines.
Combination Type
Vedotin
Special Approval(s)
Orphan drug(FDA)
Puchem SID
475550455
Drugbank ID
DB17407
General Information of The Activity Data Related to This ADC
Identified from the Human Clinical Data
Click To Hide/Show 1 Activity Data Related to This Level
Standard Type NCT Number Clinical Status Clinical Trial Description
Objective Response Rate (ORR)  NCT04868344
Phase 1
An open-label, dose-finding, phase 1 study in solid tumors.
Full List of Activity Data of This Antibody-drug Conjugate
Identified from the Human Clinical Data
Click To Hide/Show 1 Activity Data Related to This Level
Experiment 1 Reporting the Activity Date of This ADC [1]
Efficacy Data Objective Response Rate (ORR)
40.00% (SCCHN)
44.00% (NPC)
0.00% (CRC)
Patients Enrolled
Patients with advanced or metastatic solid tumors who had failed outcomes from or were not able to receive standard treatment were enrolled in phase 1a without EGFR prescreening. Phase 1b recruited EGFR-positive patients with refractory advanced squamous cell carcinomas of the head and neck (SCCHN), nasopharyngeal carcinoma (NPC), and colorectal cancer (CRC).

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Administration Dosage
An intravenous dose of 0.10 to 2.50 mg/kg of MRG003 was administered every 3 weeks during phase 1a. During phase 1b, patients were administered the recommended dose identified in phase 1a.
Related Clinical Trial
NCT Number NCT04868344  Clinical Status Phase 1
Clinical Description An open-label, dose-finding, phase 1 study in solid tumors.
Primary Endpoint
The MRG003 recommended dose was 2.50 mg/kg.
Other Endpoint
The objective response rates for SCCHN, NPC, and CRC were 40.00%, 44.00%, and 0.00%, and the disease control rates were 100.00%, 89.00%, and 25.00%, respectively. The median DOR of all patients was 5.60 months (SCCHN: DOR, 5.60 months; 95% CI,2.80-5.60; NPC: not estimable). The median PFS of all patients was 2.80 months (95% CI,1.20-4.10 months), and the PFS of SCCHN, NPC, and CRC was 2.80 (95% CI,0.60-6.80) months, 4.00 (95% CI, 1.20-not reached) months, and 1.20 (95% CI, 0.50-2.80) months, respectively. SCCHN cohort reached the median OS as of the data cutoff date, which was 11.80 (95% CI, 3.40-11.80) months.

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References
Ref 1 Evaluation of Safety of Treatment With Anti-Epidermal Growth Factor Receptor Antibody Drug Conjugate MRG003 in Patients With Advanced Solid Tumors: A Phase 1 Nonrandomized Clinical Trial. JAMA Oncol. 2022 Jul 1;8(7):1042-1046.

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