Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
REGN7508 · 11 trials · 7 indications
Cohort 1
Cohort 1 and 2
Part 1
Part 1
Part 2
Part 2
Defined as the composite of International Society on Thrombosis and Haemostasis (ISTH) major bleeding, ISTH Clinically Relevant Non-Major (CRNM) bleeding, or minor bleeding
Composite endpoint that includes asymptomatic deep DVT (deep venous thrombosis) detected by unilateral venography of the operated leg; confirmed symptomatic DVT of either leg; confirmed fatal or nonfatal pulmonary embolism (PE) including unexplained death for which PE cannot be ruled out.
Treatment-emergent adverse events are defined as those that are not present at baseline or represent the exacerbation of a pre-existing condition during the on-treatment period.
Treatment-emergent adverse events are defined as those that are not present at baseline or represent the exacerbation of a pre-existing condition during the on-treatment period.
| Arm | Type | Description |
|---|---|---|
| REGN7508 | EXPERIMENTAL | - |
| REGN9933 | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| REGN7508 + Placebo | EXPERIMENTAL | - |
| Apixaban + Placebo | ACTIVE_COMPARATOR | - |
| Cohort 1 | EXPERIMENTAL | - |
| Cohort 2 | EXPERIMENTAL | - |
| Apixaban | ACTIVE_COMPARATOR | - |
| REGN7508 and Placebo | EXPERIMENTAL | - |
| Placebo and ASA | ACTIVE_COMPARATOR | - |
| IV REGN7508 | EXPERIMENTAL | - |
| IV Placebo, SC REGN7508 | EXPERIMENTAL | - |
| IV Placebo, apixaban | ACTIVE_COMPARATOR | - |
| IV Placebo, enoxaparin | ACTIVE_COMPARATOR | - |
| Enoxaparin | ACTIVE_COMPARATOR | - |
| Cohort 1 Lowest IV Dose | EXPERIMENTAL | Randomized 3:1 |
| Cohort 2 Low IV Dose | EXPERIMENTAL | Randomized 3:1 |
| Cohort 3 Mid IV Dose | EXPERIMENTAL | Randomized 3:1 |
| Cohort 4 High IV Dose | EXPERIMENTAL | Randomized 3:1 |
| Cohort 5 Higher IV Dose | EXPERIMENTAL | Randomized 3:1 |
| Cohort 6 High SC Dose | EXPERIMENTAL | Randomized 3:1 |
| Cohort 7 Higher SC Dose | EXPERIMENTAL | Randomized 3:1 |
| Optional: Cohort 8 Highest IV or SC Dose | EXPERIMENTAL | Randomized 3:1 |
| Cohort 9 High SC Dose | EXPERIMENTAL | Randomized 3:1 |
| Optional: Cohort 10 Highest SC Dose | EXPERIMENTAL | Randomized 3:1 |
| Name | Type | Description |
|---|---|---|
| REGN7508 | DRUG | Administered per the protocol |
| REGN9933 | DRUG | Administered per the protocol |
| Placebo | DRUG | Administered per the protocol |
| Apixaban | DRUG | Administered per the protocol |
| Rivaroxaban | DRUG | Administered per the protocol |
| Acetylsalicylic Acid (ASA) | DRUG | Administered per the protocol |
| Enoxaparin | DRUG | Administered per the protocol |
| REGN7508 (IV) | DRUG | Administered sequential, ascending single intravenous (IV) dose |
| REGN7508 (SC) | DRUG | Administered sequential, ascending single subcutaneous (SC) dose |
| Matching Placebo (IV) | DRUG | Administered sequential, ascending single intravenous (IV) dose |
| Matching Placebo (SC) | DRUG | Administered sequential, ascending single subcutaneous (SC) dose |
Key Inclusion Criteria: 1. Is undergoing PICC placement for Intravenous (IV) administration of clinically indicated medications, including chemotherapy, antibiotics, TPN, and/or other indications as described in the protocol 2. Has Eastern Cooperative Oncology Group Performance (ECOG) Status ≤3 or ...