Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
PRT811 · 1 trial · 2 indications
Dose limiting toxicities will be evaluated through the first cycle
The MTD will be established for further investigation in participants with solid tumors and gliomas
The RP2D will be established for further investigation in participants with solid tumors and gliomas
| Arm | Type | Description |
|---|---|---|
| PRT811 | EXPERIMENTAL | PRT811 will be administered orally |
| Name | Type | Description |
|---|---|---|
| PRT811 | DRUG | PRT811 will be administered orally |
Inclusion Criteria: * Malignancies that are refractory to or intolerant of established therapies known to provide clinical benefit for the malignancy in question, or in the opinion of the Investigator, not be a candidate for such therapies * Subjects must have recovered from the effects of any prio...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Merck & Co., Inc. | MRK | 3 | PHASE2 | Pembrolizumab, Gardasil 9 |
| Incyte Corporation | INCY | 1 | PHASE2 | Retifanlimab |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115 |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | Aldesleukin |
| AstraZeneca PLC | AZN | 1 | - | Trastuzumab deruxtecan |
PRT811 is an investigational small molecule being studied in adults with advanced solid tumors, including recurrent glioma and central nervous system lymphoma. It is a biomarker-selected oncology candidate, meaning trial enrollment is guided by a molecular biomarker. It is not approved for any indication and remains in clinical development.
PRT811 is being developed by Prelude Therapeutics Incorporated, a clinical-stage biopharmaceutical company that trades under the ticker symbol PRLD. Prelude Therapeutics is the sponsor of the PRT811 clinical program in oncology.
PRT811 is in Phase 1 clinical development. Its single registered trial, NCT04089449, was a Phase 1 study that has been completed. The program enrolled 86 participants and has no active trials at this time. PRT811 is investigational and has not been approved by the FDA.
PRT811 has been evaluated in one clinical trial, NCT04089449, titled A Study of PRT811 in Participants With Advanced Solid Tumors, CNS Lymphoma and Gliomas. The Phase 1 trial enrolled 86 participants aged 18 years and older in the United States and is now completed. It was an uncontrolled, non-randomized study.
No. PRT811 is an investigational drug and has not been approved by the FDA. It has completed a single Phase 1 trial, NCT04089449, in advanced solid tumors, CNS lymphoma and gliomas, and remains in clinical development under Prelude Therapeutics.