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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06413680 | A First-In Human (FIH) Study to Find Out How Well REGN10597 Medicine Given Alone or in Combination With Cemiplimab Works in Adult Participants Who Have Cancer With Tumors That Have Spread in Their Body | PHASE1 | RECRUITING | 240 | — | — | Sep 23, 2024 | Feb 3, 2030 | Apr 28, 2026 | 11 | United States |
Dose escalation
Dose escalation
Dose escalation
Dose escalation
Dose escalation
Dose escalation Grade 3 or higher per Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Dose expansion
| Arm | Type | Description |
|---|---|---|
| Phase 1: Monotherapy Dose Escalation | EXPERIMENTAL | Multiple Dose Level (DL) Cohorts to identify the Recommended Phase 2 Dose (RP2D) |
| Phase 2: Monotherapy Dose Expansion | EXPERIMENTAL | Cohort 1: Melanoma participants Cohort 2: Clear-cell Renal-Cell Carcinoma (ccRCC) participants |
| Phase 1: Combination Dose Escalation | EXPERIMENTAL | Multiple DL Cohorts to identify the RP2D |
| Phase 2: Combination Dose Expansion | EXPERIMENTAL | Cohort 1: Melanoma participants |
| Name | Type | Description |
|---|---|---|
| REGN10597 | DRUG | Administered per the protocol |
| Cemiplimab | DRUG | Administered per the protocol |
Key Inclusion Criteria: Dose escalation cohorts: 1\. Histologically or cytologically confirmed diagnosis of solid malignancy (locally advanced or metastatic) with confirmed progression on standard-of-care therapy. Participants are required to submit archival tissue if it is available Dose expansi...