Antibody-drug Conjugate Information

General Information of This Antibody-drug Conjugate (ADC)

ADC ID	DRG0CKSWS
ADC Name	CMG-901
Synonyms	CMG 901; CMG901 Click to Show/Hide
Organization	Keymed Biosciences, Inc.; Shanghai Miracogen Inc.; Lepu Biopharma Co., Ltd.; AstraZeneca PLC
Drug Status	Phase 1
Indication	In total 3 Indication(s) Gastric cancer [ICD11:2B72] Phase 1 Gastroesophageal junction cancer [ICD11:2B71] Phase 1 Pancreatic cancer [ICD11:2C10] Phase 1
	3D MOL	2D MOL
Antibody Name	Undisclosed
Antigen Name	Claudin-18.2 (CLDN18.2)		Antigen Info
Payload Name	Undisclosed
Linker Name	Undisclosed
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. Click to Show/Hide

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.