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Also known as Tusamitamab ravtansine
SAR408701 · 1 trial · 1 indication
IMP-related DLTs are defined as adverse events (AE) related to the IMPs in absence of clear evidence to the contrary, after validation by the Study Committee, and if not related to a disease progression, graded using National Cancer Institute common Toxicity Criteria (NCI-CTC) scale v4.03
| Arm | Type | Description |
|---|---|---|
| SAR408701 Monotherapy | EXPERIMENTAL | SAR408701 Dose escalation administered as a single agent intravenously, on Day 1 and once every two weeks, to patients with malignant solid tumors |
| Name | Type | Description |
|---|---|---|
| SAR408701 | DRUG | Pharmaceutical form: solution for infusion Route of administration: intravenous |
| dexamethasone | DRUG | Pharmaceutical form: solution for eye drop Route of administration: eye drop |
| naphazoline | DRUG | Pharmaceutical form: solution for eye drop Route of administration: eye drop |
| diphenhydramine | DRUG | Pharmaceutical form: tablet Route of administration: oral |
Inclusion criteria: * Locally advanced or metastatic solid malignant tumor disease for which, in the judgement of the investigator, no standard alternative therapy is available. * Inclusion is likely to be expressing CEACAM5. * At least 6 x 5 μm slides from formalin-fixed paraffin-embedded (FFPE) a...
SAR408701 is an investigational small molecule developed by Sanofi for the treatment of advanced malignant solid tumors. It is being studied in oncology and is designed to target CEACAM5, a protein expressed on certain tumor cells. It has been evaluated in a Phase 1 clinical trial in Japanese patients with advanced malignant solid tumors.
SAR408701 targets CEACAM5, a protein that is expressed on the surface of certain cancer cells. By binding to CEACAM5, the drug is designed to act against CEACAM5-expressing malignant solid tumors. The Phase 1 study of SAR408701 enrolled patients whose tumors were selected based on this biomarker.
SAR408701 is being developed by Sanofi, which trades under the ticker SNY. Sanofi is the sponsor of the clinical program evaluating SAR408701 in advanced malignant solid tumors. The drug is an investigational small molecule in the oncology therapeutic area.
SAR408701 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. The Phase 1 trial evaluating SAR408701 in Japanese patients with advanced malignant solid tumors has been completed, and no active trials are currently listed for this asset.
SAR408701 has been evaluated in one completed Phase 1 clinical trial, NCT03324113, titled Evaluation of SAR408701 in Japanese Patients With Advanced Malignant Solid Tumors. The trial enrolled 34 patients in Japan, included both sexes, and required a minimum age of 20 years. It was an uncontrolled study.
SAR408701 is being studied for the treatment of advanced malignant solid tumors, also described as malignant neoplasms. The Phase 1 trial NCT03324113 evaluated SAR408701 in Japanese patients with advanced malignant solid tumors. It is an investigational therapy and is not approved for any indication.