Antibody-drug Conjugate Information

General Information of This Antibody-drug Conjugate (ADC)

ADC ID	DRG0KYHQN
ADC Name	CMB-401
Synonyms	Anti-PEM monoclonal antibody calicheamicin; hcT.MO1 calicheamicin; hCTMO1-calicheamicin; CDP-671; LLE 33288; CMB 401; CDP 671 Click to Show/Hide
Organization	Celltech Oy
Drug Status	Terminated in phase 2
Indication	In total 2 Indication(s) Non-small cell lung cancer [ICD11:2C25] Terminated in phase 2 Ovarian cancer [ICD11:2C73] Terminated in phase 2
Drug-to-Antibody Ratio	2-3
Structure
	3D MOL	2D MOL
Antibody Name	Anti-MUC1 mAb hCTM01		Antibody Info
Antigen Name	Mucin-1 (MUC1)		Antigen Info
Payload Name	N-acetyl-gamma-calicheamicin		Payload Info
Therapeutic Target	Human Deoxyribonucleic acid (hDNA)		Target Info
Linker Name	Amide-based linker		Linker Info
Conjugate Type	Random conjugation through nucleophilic lysines.
Puchem SID	160687710
TTD ID	D07UAJ
ChEBI ID	CHEMBL2109284

General Information of The Activity Data Related to This ADC

Identified from the Human Clinical Data

Click To Hide/Show 2 Activity Data Related to This Level

Standard Type	NCT Number	Clinical Status	Clinical Trial Description
Objective Response Rate (ORR)	Undisclosed	Phase 2	This was an open-label, single-arm, multicycle,multinational,multicenter outpatient study to evaluate the efficacy of CMB-401 in terms of numbers of patients with platinum-sensitive recurrent EOC having a complete response (CR) or a partial response (PR), as assessed by change tumor size and in CA125 levels after treatment with CMB-401. Click to Show/Hide
Undisclosed	Undisclosed	Phase 1	A phase 1 study of the cytotoxic immunoconjugate CMB-401 in women with epithelial ovarian cancer (EOC).

Full List of Activity Data of This Antibody-drug Conjugate

Identified from the Human Clinical Data

Click To Hide/Show 2 Activity Data Related to This Level

Experiment 1 Reporting the Activity Date of This ADC			[1]
Efficacy Data	Objective Response Rate (ORR)	0.00%
Patients Enrolled	Platinum-sensitive EOC (recurrence >6 months after completion of an initial platinumcontaining chemotherapy regimen).
Administration Dosage	Initial infusion of 35 mg/m² of hCTM01 (anti-PEM antibody not conjugated to calicheamicin) over a period of 15 min, followed 45 min later (60 min from the start of the initial infusion) by an infusion of 16 mg/m² of CMB-401 over an additional 60 min, up to 7 cycles, with 4 weeks between cycles.
Experiment 2 Reporting the Activity Date of This ADC			[2]
Patients Enrolled	EOC refractory to or unsuitable for platinum/standard therapy; with a WHO performance status of 0-2; life expectancy of more than three months and fulfilling other standard eligibility criteria.
Administration Dosage	Up to four cycles of a dual infusion of 35.00 mg/m² hCTMO1 'predose' followed by doses of CMB-401 which were increased for each cohort, CMB-401 dosing commenced at 2 mg/m² and progressed via seven cohorts to 16.00 mg/m².

References

Ref 1	A phase 2 study of the cytotoxic immunoconjugate CMB-401 (hCTM01-calicheamicin) in patients with platinum-sensitive recurrent epithelial ovarian carcinoma. Cancer Immunol Immunother. 2003 Apr;52(4):243-8.
Ref 2	Phase I open study of the effects of ascending doses of the cytotoxic immunoconjugate CMB-401 (hCTMO1-calicheamicin) in patients with epithelial ovarian cancer. Ann Oncol. 2000 Jun;11(6):735-41.