Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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 being studied for the treatment of malignant neoplasms, which are cancerous tumors. It is currently in clinical development for oncology indications, specifically targeting advanced malignant solid tumors. The drug is being evaluated in a clinical trial setting to assess its potential effects in patients with these conditions.
SAR408701 is being developed by Sanofi, a global biopharmaceutical company listed on the stock exchange under the ticker symbol SNY. Sanofi is conducting clinical research on this investigational oncology drug, which is currently in Phase 1 development for the treatment of malignant neoplasms.
SAR408701 is in Phase 1 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. The Phase 1 trial for SAR408701 has been completed, and the drug remains under investigation for its safety and potential efficacy in treating malignant solid tumors.
SAR408701 has been studied in a completed Phase 1 clinical trial identified as NCT03324113. This trial evaluated SAR408701 in Japanese patients with advanced malignant solid tumors. The study enrolled 34 participants and was conducted in Japan, with participants aged 20 years and older.
SAR408701 is a distinct investigational drug candidate developed by Sanofi. It is not known to be the same as any other marketed or investigational drug. The drug is being studied under its own unique identifier, SAR408701, and is currently in Phase 1 clinical development for oncology indications.