Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 2308 |
| INN | Dalotuzumab |
| Status | Terminated |
| Drug code(s) | MK-0646, F50035, h7C10 |
| Brand name | None |
| mAb sequence source | mAb humanized |
| General Molecular Category | Naked monospecific |
| Format, general category | Full length Ab |
| Format details | None |
| Isotype (Fc) | IgG1 |
| Light chain isotype | kappa |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | None |
| Discovery method/technology | None |
| Target(s) | IGF-1R |
| Indications of clinical studies | Breast Cancer, Colorectal Cancer, Non-small-cell Lung cancer, Neuroendocrine Tumors, Pancreatic Cancer, Solid Tumor, Multiple Myeloma |
| Primary therapeutic area | Cancer |
| Most advanced stage of development (global) | Terminated at Phase 2/3 |
| Status | Inactive |
| Start of clinical phase (IND filing or first Phase 1) | December 15, 2005 |
| Start of Phase 2 | June 15, 2007 |
| Start of Phase 3 | December 15, 2007 |
| 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 | Pierre Fabre |
| Licensee/Partner | Merck |
| Comments about company or candidate | One Phase 2 study active but not recruiting as of Aug 2017. Total of 20 studies sponsored at least in part by Merck listed on clinicaltrials.gov. Phase 2/3 study done in colorectal patients; results showed that the trial was stopped at the 1st interim analysis with 345 wild-type KRAS patients enrolled as neither dalotuzumab dosing regimen achieved proof-of-concept. Median PFS for all randomized wild-type KRAS status patients was 3.3mth in q 1wk and 5.4 in q 2wk vs 5.6 in the placebo group. Median overall survival (OS) for wild-type KRAS patients was 10.8mth in q 1wk and 11.6 in q 2wk vs 14.0 in the placebo arm. Specific adverse events did not appear to explain the difference in PFS or OS observed. Poor results also observed in Phase 2 studies in breast cancer and prostate cancer. |
| Full address of company | Castres, 1 Avenue d'Albi, France Europe France https://www.pierre-fabre.com/fr-fr |
Jan 2005 publication from Pierre Fabre authors: We have generated a humanized anti-IGF-IR antibody h7C10 that blocks in vitro IGF-I and IGF-II-induced cell proliferation of MCF-7 breast cancer cells. Analysis of the IGF-I transduction cascade demonstrated that the humanized anti-IGF-IR antibody and its murine parental form block IGF-I-induced tyrosine phosphorylation, both its beta-chain and IRS-1 tyrosine phosphorylation. https://pubmed.ncbi.nlm.nih.gov/15386423/
| Anticipated events | None |
| Factor(s) contributing to discontinuation | Lack of efficacy |