Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as RP1, intra-tumoral injection, oncolytic virus, RP1
RP1, intra-tumoral, oncolytic virus · 1 trial · 4 indications
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...
RP1 is an investigational oncolytic virus being developed for the treatment of Non-Small Cell Lung Cancer (NSCLC) and Merkel Cell Carcinoma. It is administered via intra-tumoral injection and is currently in Phase 2 clinical development for these indications.
RP1 is being developed by Replimune Group, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol REPL. The company is conducting clinical trials to evaluate RP1 as a monotherapy and in combination with other agents.
RP1 is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA. The drug has received FDA designations including Accelerated Approval, Breakthrough Therapy, and Priority Review, indicating its potential significance in oncology.
RP1 is being studied in two active clinical trials. NCT03767348 is a Phase 2 trial evaluating RP1 monotherapy and RP1 in combination with nivolumab in patients with NSCLC and other cancers. NCT04349436 is a Phase 1 trial investigating RP1 in organ transplant patients with advanced skin malignancies.
Yes, RP1 is also known as RP1, intra-tumoral injection, oncolytic virus. These alternative names describe the drug's administration route and mechanism as an oncolytic virus delivered directly into tumors.