Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 2164 |
| INN | Clivatuzumab tetraxetan |
| Status | Terminated |
| Drug code(s) | IMMU-107, PAM4-DOTA |
| Brand name | PAM4-Cide |
| mAb sequence source | mAb humanized |
| General Molecular Category | Radioimmunotherapy, RIC |
| Format, general category | Full length Ab conjugate |
| Format details | None |
| Isotype (Fc) | IgG1 |
| Light chain isotype | kappa |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | Y-90 |
| Discovery method/technology | None |
| Target(s) | MUC5AC |
| Indications of clinical studies | Pancreatic Cancer |
| Primary therapeutic area | Cancer |
| Most advanced stage of development (global) | Terminated at Phase 3 |
| Status | Inactive |
| Start of clinical phase (IND filing or first Phase 1) | November 15, 2003 |
| Start of Phase 2 | January 15, 2008 |
| Start of Phase 3 | January 15, 2014 |
| 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 | Gilead Sciences Inc |
| Licensee/Partner | None |
| Comments about company or candidate | Oct 2020: Gilead Sciences acquired biotech company Immunomedics in a $21 billion deal March 2016: as a result of an interim futility analysis by the Data and Safety Monitoring Board, IMMU has discontinued the ph 3 PANCRIT-1 trial testing clivatuzumab in metastatic pancreatic cancer. The DSMB conducted an interim analysis on overall survival, which showed that the treatment arm did not demonstrate a sufficient improvement in OS vs. placebo. Fast track, orphan designations in US; Immunomedics seeks to out-license |
| Full address of company | 333 Lakeside Drive Foster City, CA 94404 North America United States of America https://www.gilead.com/our-company/us-locations |
Described in https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4015478/
| Anticipated events | None |
| Factor(s) contributing to discontinuation | Lack of efficacy |