Database for
Therapeutic Antibodies
Therapeutic Antibodies
| 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 |
| Target(s) | VEGFR2 |
| Indications of clinical studies | Gastric cancer, Non-Small Cell Lung Cancer, Solid tumors |
| Primary therapeutic area | Cancer |
| 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 | 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 |
Anti-VEGFR2 Human-mouse Chimeric Monoclonal Antibody; Kintuximab Injection (Recombinant Anti-VEGFR2 Human-Mouse Chimeric Monoclonal Antibody Injection)
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |