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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04349436 | Study to Investigate the Efficacy and Safety of RP1 in Adult Patients With Organ Transplants and Advanced Skin Malignancies | PHASE1 | ACTIVE NOT_RECRUITING | 69 | — | — | May 15, 2020 | Nov 1, 2029 | Apr 22, 2026 | 24 | United States |
The effect of RP1 on objective response rate (ORR) as assessed by Independnet Central Review (ICR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1)
The effect of RP1 on ORR as assessed by investigator review per modified RECIST 1.1 (mRECIST 1.1)
The safety and tolerability of single-agent RP1 in solid organ transplant patients with other skin cancers as assessed by incidence of patients with treatment-emergent adverse events (TEAEs) and by incidence of patients with biopsy-proven allograft rejection.
| Arm | Type | Description |
|---|---|---|
| RP1, intra-tumoral injection, oncolytic virus | EXPERIMENTAL | RP1 administered as an intra-tumoral injection every 2 weeks. |
| Name | Type | Description |
|---|---|---|
| RP1, intra-tumoral injection, oncolytic virus | BIOLOGICAL | Genetically modified herpes simplex type 1 virus |
Key Inclusion Criteria: 1. Voluntary agreement to provide written informed consent prior to any study procedures and the willingness and ability to comply with all aspects of the protocol and understand the risk to their organ allograft. 2. Male or female at birth and at least 18 years of age prior...