Antibody-drug Conjugate Information

General Information of This Antibody-drug Conjugate (ID: DRG0HSRYV)
ADC Name
DM005
Synonyms
DM005; YH013
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Organization
Biocytogen (Originator);Duoma Biopharma
Drug Status
Phase 1
Drug-to-Antibody Ratio
4
Structure
Antibody Name
Anti-EGFR/c-Met bsAb
  Antibody Info 
Antigen Name
Hepatocyte growth factor receptor (MET); Epidermal growth factor receptor (EGFR)
  Antigen Info 
Payload Name
BCPT02
  Payload Info 
Payload Target
DNA topoisomerase 1 (TOP1)
  Target Info 
Linker Name
Hydrophilic, protease-cleavable linker
  Linker Info 
Conjugate Type
Undisclosed
Combination Type
BLD1102
2027 Update
The disease landscape of This ADC
2027 Update
The clinical trial pipelines of This ADC
Disease Name Phase 1 Phase 2 Phase 3 Approved
Gastroesophageal junction adenocarcinoma
1 Trials
Clinical trial identifier
NCT06515990; CTR20244842; ChiCTR2500095720
Lung cancer
1 Trials
Clinical trial identifier
NCT06515990; CTR20244842; ChiCTR2500095720
Unspecific solid tumor
1 Trials
Clinical trial identifier
NCT06515990; CTR20244842; ChiCTR2500095720
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
Undisclosed  NCT06515990
PHASE1
A Phase 1, Multicenter, Open-label, First-in-human, Dose Escalation and Expansion Study of DM005 in Patients With Advanced 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]
Patients Enrolled
Key inclusion criteria: signed consent; age ≥18; advanced/metastatic solid tumors (NSCLC, gastroesophageal/colorectal/HCC/pancreatic/HNSCC) refractory to standard therapy; ECOG 0-2; life expectancy ≥3 months; measurable disease (RECIST 1.1).
Administration Dosage
An IV infusion of DM005 will be administrated approximately 30-60 min on D1 once Q3W, 0.5, 1, 2, 4, 6, 8 mg/kg.
Related Clinical Trial
NCT Number NCT06515990  Clinical Status PHASE1
Clinical Description A Phase 1, Multicenter, Open-label, First-in-human, Dose Escalation and Expansion Study of DM005 in Patients With Advanced Solid Tumors
Primary Endpoint
Primary endpoints include DLT incidence (grade 3 neurological/grade 4 toxicities) and MTD determination (0/3 or 1/6 DLT rate) for DM005 over 12 months.
Other Endpoint
Secondary endpoints comprise PK parameters (AUC, Cmax, Tmax, Ctrough) and ORR assessment (RECIST v1.1) within 12 months.
References
Ref 1 A Study of DM005 in Patients With Advanced Solid Tumors