Antibody-drug Conjugate Information

General Information of This Antibody-drug Conjugate (ADC)

ADC ID	DRG0KYHQN
ADC Name	CMB-401
Synonyms	CMB-401; CDP-671; hCTMO1-calicheamicin Click to Show/Hide
Organization	Celltech (Originator);Pfizer (Top20 MNC)
Drug Status	Phase 2 (discontinued)
Drug-to-Antibody Ratio	2 to 3
Structure
	3D MOL	2D MOL
Antibody Name	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 Lysines

The indication landscape of This ADC(2027 Update)

The clinical trial pipeline of This ADC(2027 Update)

Indication

Phase 1

Phase 1/2

Phase 2

Phase 2/3

Phase 3

New Drug Application

Approved

Ovarian cancer

1 Trials

Trial ID
https://pubmed.ncbi.nlm.nih.gov/10942064/

ADC-specific functional property(2027 Update)

Binding Affinity

Click To Hide/Show 1 ADC-specific functional property Data

Dissocation Constant (Kd)	Binding Target	Description	Reference
0.81 ug/mL	Mucin-1 (MUC1)	The binding data follow a normal curve and show that hCTM01 has ~30% increased affinity with respect to the murine antibody.	[1]

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			[2]
Efficacy Data	Objective Response Rate (ORR)	0%
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			[3]
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 calicheamicin conjugate with a fully humanized anti-MUC1 antibody shows potent antitumor effects in breast and ovarian tumor xenografts
Ref 2	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 3	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.