Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03324113 | Evaluation of SAR408701 in Japanese Patients With Advanced Malignant Solid Tumors | PHASE1 | COMPLETED | 34 | — | — | Oct 17, 2017 | Dec 26, 2022 | Aug 5, 2025 | 3 | Japan |
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...