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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03192345 | A First-in-human Study of the Safety, Pharmacokinetics, Pharmacodynamics and Anti-tumor Activity of SAR439459 Monotherapy and Combination of SAR439459 and Cemiplimab in Patients With Advanced Solid Tumors | PHASE1 | COMPLETED | 161 | — | — | Jun 9, 2017 | Jan 17, 2022 | Aug 7, 2024 | 34 | United States, Australia +11 |
Incidence of DLTs at Cycle 1 and/or 2 in Parts 1A and 1B.
Efficacy as documented by ORR will be assessed by evaluation of antitumor response information according to RECIST 1.1 (Part 2B).
| Arm | Type | Description |
|---|---|---|
| Dose Escalation SAR439459 monotherapy | EXPERIMENTAL | SAR439459 administered intravenously every 2 weeks in a 14-day cycle with escalating doses |
| Dose Expansion SAR439459 monotherapy | EXPERIMENTAL | SAR439459 administered intravenously every 3 weeks in a 21-day cycle with the previously determined recommended doses as the patients will be randomized to 2 different doses |
| Dose Escalation SAR439459 + cemiplimab combination | EXPERIMENTAL | SAR439459 + cemiplimab combination administered intravenously every 2 weeks in a 14-day cycle or every 3 weeks in a 21-day cycle with escalating SAR439459 doses and cemiplimab |
| Dose Expansion SAR439459 + cemiplimab combination | EXPERIMENTAL | SAR439459 + cemiplimab combination administered intravenously every 3 weeks in a 21-day cycle with previously determined SAR439459 doses and cemiplimab |
| Name | Type | Description |
|---|---|---|
| SAR439459 | BIOLOGICAL | Pharmaceutical form: powder for solution for infusion Route of administration: intravenous infusion |
| Cemiplimab REGN2810 | DRUG | Pharmaceutical form: solution for infusion Route of administration: intravenous infusion |
Inclusion criteria: Dose escalation (Part 1A and Part 1B) * Patients with histologically confirmed, advanced unresectable or metastatic solid tumor whom in the opinion of the Investigator does not have a suitable alternative therapy. Dose expansion (Part 2A) * Patients with histologically confir...