Antibody-drug Conjugate Information

General Information of This Antibody-drug Conjugate (ADC)

ADC ID	DRG0UIDCY
ADC Name	NJH-395
Synonyms	NJH 395; NJH395; Immune stimulator antibody conjugate Click to Show/Hide
Organization	Novartis Pharma AG
Drug Status	Phase 1
Indication	In total 7 Indication(s) HER2(+) bladder cancer [ICD11:2C94] Phase 1 HER2(+) colorectal cancer [ICD11:2B91] Phase 1 HER2(+) gastroesophageal cancer [ICD11:2B71] Phase 1 HER2(+) nasopharynx cancer [ICD11:2B6B] Phase 1 HER2(+) non-small cell lung cancer [ICD11:2C25] Phase 1 HER2(+) pancreatic cancer [ICD11:2C10] Phase 1 HER2(+) small intestine adenocarcinoma [ICD11:2B80] Phase 1
	3D MOL	2D MOL
Antibody Name	Anti-HER2 NJH395 mAb		Antibody Info
Antigen Name	Receptor tyrosine-protein kinase erbB-2 (ERBB2)		Antigen Info
Payload Name	Tolllike receptor 7 agonist		Payload Info
Therapeutic Target	Toll-like receptor 7 (TLR7)		Target Info
Linker Name	Noncleavable linker		Linker Info
Puchem SID	472421730 , 440234924
ChEBI ID	CHEMBL4594580

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)	NCT03696771	Phase 1	A phase 1, multicenter, open-label dose finding study of NJH395, administered intravenously in patients with non-breast HER2+ advanced malignancies.

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)	0.00%
Patients Enrolled	Patients with nonbreast HER2+ advanced malignancies.
Administration Dosage	5 dose cohorts (0.10-1.60 mg/kg).
*Related Clinical Trial*
NCT Number	NCT03696771	Clinical Status	Phase 1
Clinical Description	A phase 1, multicenter, open-label dose finding study of NJH395, administered intravenously in patients with non-breast HER2+ advanced malignancies.

References

Ref 1	Phase Ia Study of Anti-NaPi2b Antibody-Drug Conjugate Lifastuzumab Vedotin DNIB0600A in Patients with Non-Small Cell Lung Cancer and Platinum-Resistant Ovarian Cancer. Clin Cancer Res. 2020 Jan 15;26(2):364-372. doi: 10.1158/1078-0432.CCR-18-3965.