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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06960395 | Safety and Preliminary Efficacy of VIR-5525 and VIR-5525 + Pembrolizumab in Participants With Locally Advanced or Metastatic Solid Tumors | PHASE1 | RECRUITING | 450 | — | — | Jul 22, 2025 | Aug 1, 2029 | Apr 13, 2026 | 4 | United States, Australia |
Objective: To evaluate the safety and tolerability of escalating doses of VIR-5525 as monotherapy (Part 1) and in combination with pembrolizumab (Part 3). Endpoint: Incidence and severity of AEs, including DLTs, with severity determined according to NCI CTCAE v5.0, ASTCT CRS, or ASTCT ICANS Consensus Grading, as appropriate.
Objective: To evaluate the preliminary anti-tumor activity of VIR-5525 as monotherapy (Part 2) and in combination with pembrolizumab (Part 4) at the recommended dose(s) for expansion cohorts. Endpoint: Objective response, defined as a CR or PR per RECIST v1.1.
| Arm | Type | Description |
|---|---|---|
| Part 1: VIR-5525 Monotherapy Dose Escalation | EXPERIMENTAL | Screening Period: Up to 28 days Treatment Period: Once successfully screened, enrolled participants may receive study intervention of VIR-5525 in monotherapy. |
| Part 2: VIR-5525 Monotherapy Dose Expansion | EXPERIMENTAL | Screening Period: Up to 28 days Treatment Period: Once successfully screened, enrolled participants may receive study intervention of VIR-5525 in monotherapy. |
| Part 3: VIR-5525 Combination Dose Escalation | EXPERIMENTAL | Screening Period: Up to 28 days Treatment Period: Once successfully screened, enrolled participants may receive study intervention of VIR-5525 in combination with pembrolizumab. |
| Part 4: VIR-5525 Combination Dose Expansion | EXPERIMENTAL | Screening Period: Up to 28 days Treatment Period: Once successfully screened, enrolled participants may receive study intervention of VIR-5525 in combination with pembrolizumab. |
| Name | Type | Description |
|---|---|---|
| VIR-5525 | DRUG | Pharmaceutical Form: Solution for Infusion Route of Administration: Intravenous (IV) infusion |
| Pembrolizumab | DRUG | Pharmaceutical Form: Solution for Infusion Route of Administration: Intravenous (IV) infusion |
Inclusion Criteria: I 01. Are ≥ 18 years of age, or at the country's legal age of majority of the legal adult age is \>18 years, at the time of signing the ICF. I 02. Have an ECOG performance status of 0 to 1. I 03. Have a life expectancy of at least 12 weeks. I 04. Have histological, pathologic...