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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04401020 | First-in-human Single Agent Study of SAR442257 in RRMM and RR-NHL | PHASE1 | COMPLETED | 47 | — | — | Jul 24, 2020 | May 11, 2026 | May 29, 2026 | 16 | United States, Czechia +3 |
MTD: defined as the highest dose level (DL) with highest probability of Investigational Medicinal Product (IMP)-related dose limiting toxicity (DLT) rate within the target range (16 to 33%) among dose levels with less than 0.25 probability of DLT rate above target (\>33%)
RP2D: defined as the dose selected for the further single agent testing in the future study
| Arm | Type | Description |
|---|---|---|
| Dose escalation | EXPERIMENTAL | SAR442257 will be given intravenously with lead-in doses (LID) in the first-week, followed by once weekly until week 4 (Cycle 1) and once weekly for each subsequent cycle(s). |
| Name | Type | Description |
|---|---|---|
| SAR442257 | DRUG | Pharmaceutical form: Sterile powder for reconstitution Route of administration: Intravenous infusion |
Inclusion criteria : Participant must be at least 18 years of age or of the country's legal age of majority if the legal age is \>18 years old, at the time of signing the informed consent. Life expectancy of at least 12 weeks. Eastern Cooperative Oncology Group (ECOG) performance status ≤2. RRMM ...