General Information of This Antibody-drug Conjugate (ADC)
ADC ID
DRG0CKSWS
ADC Name
CMG-901
Synonyms
CMG 901; CMG-901; CMG901; MRG005; Sonesitatug vedotin; AZD0901
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Organization
Keymed Biosciences, Inc.; Shanghai Miracogen Inc.; Lepu Biopharma Co., Ltd.; AstraZeneca PLC
Drug Status
Phase 3
Indication
In total 5 Indication(s)
Gastric cancer
Phase 3
Clinical Trial
Biliary tract cancer
Phase 2
Clinical Trial
Oesophageal cancer
Phase 2
Clinical Trial
Pancreatic cancer
Phase 2
Clinical Trial
Solid tumor
Phase 1
Clinical Trial
Drug-to-Antibody Ratio
Undisclosed
Antibody Name
Sonesitatug
 Antibody Info 
Antigen Name
Claudin-18.2 (CLDN18.2)
 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 Cysteines
Combination Type
vedotin
Special Approval(s)
Breakthrough therapy(FDA); Breakthrough therapy(NMPA); Fast track(FDA); Orphan drug(FDA)
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)  NCT04805307
Phase 1
An open-label, phase 1, dose escalation and dose expansion study to evaluate the safety, tolerability, pharmacokinetics and antitumor activities of CMG901 in subjects with advanced unresectable or metastatic solid tumor.

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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)
75.00% (Gastric/GEJ Cancer)
Patients Enrolled
Patients with advanced malignant tumors.
Administration Dosage
Day 1 in 3-week (Q3W) cycle 3.40 mg/kg.
Related Clinical Trial
NCT Number NCT04805307  Clinical Status Phase 1
Clinical Description An open-label, phase 1, dose escalation and dose expansion study to evaluate the safety, tolerability, pharmacokinetics and antitumor activities of CMG901 in subjects with advanced unresectable or metastatic solid tumor.
References
Ref 1 A phase 1a dose-escalation, multicenter trial of anti-claudin 18.2 antibody drug conjugate CMG901 in patients with resistant/refractory solid tumors. J Clin Oncol. 2023 41:4_suppl, 352-352.