Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
PRT543 · 1 trial · 8 indications
Dose limiting toxicities (DLTs) will be evaluated during the first cycle
The maximum tolerated dose (MTD) will be established for further investigation in participants with advanced malignancies who have failed prior treatments.
The recommended phase 2 dose (RP2D) and optimal dosing schedule of PRT543 will be established for further investigation in participants with advanced malignancies who have failed prior treatments.
| Arm | Type | Description |
|---|---|---|
| PRT543 | EXPERIMENTAL | PRT543 will be administered orally |
| Name | Type | Description |
|---|---|---|
| PRT543 | DRUG | PRT543 will be administered orally |
Inclusion Criteria: * Metastatic or advanced solid tumor; or advanced diffuse large B-cell lymphoma; or advanced mantle cell lymphoma; or relapsed myelodysplastic syndrome, acute myeloid leukemia or chronic myelomonocytic leukemia; or relapsed myelofibrosis. All malignancies must be refractory to e...
| 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 |
PRT543 is an investigational small molecule developed by Prelude Therapeutics for relapsed or refractory advanced solid tumors and certain hematologic malignancies. It is a biomarker-selected therapy, meaning trial enrollment was guided by molecular features of the tumor. PRT543 remains in clinical development and is not approved for any indication.
PRT543 was studied in adults with relapsed or refractory advanced solid tumors, including adenoid cystic carcinoma, and in several hematologic malignancies such as diffuse large B-cell lymphoma, mantle cell lymphoma, acute myeloid leukemia, myelodysplasia, myelofibrosis, and chronic myelomonocytic leukemia. It is investigational and not approved for any use.
PRT543 is being developed by Prelude Therapeutics Incorporated, a clinical-stage biopharmaceutical company that trades under the ticker PRLD. Prelude Therapeutics sponsored the Phase 1 study of PRT543 conducted in the United States.
PRT543 is in Phase 1 clinical development. Its single registered trial, NCT03886831, was a Phase 1 study that has since been completed. PRT543 is investigational and has not been approved by the FDA for any indication.
PRT543 has been evaluated in one registered clinical trial, NCT03886831, titled A Study of PRT543 in Participants With Advanced Solid Tumors and Hematologic Malignancies. The Phase 1 trial enrolled 232 participants aged 18 years and older in the United States and is now completed.
No. The Phase 1 trial of PRT543, NCT03886831, was an uncontrolled, open-label study without randomization or double blinding. It enrolled 232 adult participants with relapsed or refractory advanced solid tumors and hematologic malignancies and has been completed.