Kintuximab, gentuximab, cintuximab (not WHO assigned INN) Clinical Naked monospecific

Antibody Information

Entry ID	891
INN	None
Status	Clinical
Drug code(s)	Kintuximab, gentuximab, cintuximab (not WHO assigned INN)
Brand name	None
mAb sequence source	mAb chimeric
General Molecular Category	Naked monospecific
Format, general category	Full length Ab
Format details	None
Isotype (Fc)	TBD
Light chain isotype	TBD
Linker	None
Ave. DAR	None
Conjugated/fused moiety	None
Discovery method/technology	None

Therapeutic information

Target(s)	VEGFR2
Indications of clinical studies	Gastric cancer, Non-Small Cell Lung Cancer, Solid tumors
Primary therapeutic area	Cancer

Development stage information

Phase lengths*

*The graph represents early-stage clinical development phase lengths. For molecules approved or under evaluation for marketing authorization in the US is provided a complete overview of all clinical development phase lengths. Phase lengths are calculated from the start of the first in human (FIH) study (Start of clinical phase). “Start of Phase 2” bar represents Phase 1 length (Start of clinical phase to start of Phase 2); “Start of Phase 3” bar represents Phase 1+2 length (Start of clinical phase to start of Phase 3); “Date BLA/NDA submitted” bar represents Phase 1+2+3 length (Start of clinical phase to Date BLA/NDA submitted); and “Date of first US approval” bar represents Phase 1 to first US approval length (Start of clinical phase to Date of first US approval).

Most advanced stage of development (global)	Phase 3
Status	Active
Start of clinical phase (IND filing or first Phase 1)	October 11, 2017
Start of Phase 2
Start of Phase 3	May 30, 2022
Date BLA/NDA submitted to FDA
Year of first approval (global)	None
Date of first US approval
INN, US product name	None
US or EU approved indications	None

Company information

Company	GeneScience Pharmaceuticals Co. Ltd.
Licensee/Partner	Changchun Jinsai Pharmaceutical Co. Ltd.
Comments about company or candidate	NCT05919381 / CTR20220815 Phase 3 study of cintuximab injection combined with paclitaxel injection versus placebo combined with paclitaxel injection for advanced gastric or gastroesophageal junction adenocarcinoma after failure of first-line standard therapy started in May 2022; contact email is fengshaohua@gensci-china.com; protocol number is Gensci043-GC-Ⅲ01. CTR20210189 Phase 1 in NSCLC started in April 2021 active not recruiting. NCT05223595 Phase 1 in NSCLC started in April 2021 recruiting as of last update in Feb 2022. NCT04053205 Phase 1/2 study in Advanced Gastric or Gastroesophageal Junction Cancer not yet recruiting as last update in Aug 2019; est start date is Aug 2019. Phase 1 NCT03313219 study started in Oct 2017 has unknown status; last updated in Dec 2017 CTR20171077 Phase 1 study started in Oct 2017 completed in Nov 2019.
Full address of company	No. 72 Tianhe Street, Changchun High-Tech Industrial Development Zone, Changchun, Jilin Province, China, Postal code: 130012 Asia China https://en.gensci-china.com/contactus.html

Description/comment

Anti-VEGFR2 Human-mouse Chimeric Monoclonal Antibody; Kintuximab Injection (Recombinant Anti-VEGFR2 Human-Mouse Chimeric Monoclonal Antibody Injection)

Additional information

Anticipated events	None
Factor(s) contributing to discontinuation	None