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 | 2 | PHASE2 | pembrolizumab |
| Incyte Corporation | INCY | 1 | PHASE2 | Chemotherapy, Retifanlimab |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | E7 TCR-T cells, Aldesleukin |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115, pembrolizumab |
| AstraZeneca PLC | AZN | 1 | - | Trastuzumab deruxtecan |
PRT543 is an investigational small molecule being studied for the treatment of relapsed or refractory advanced solid tumors. It is also being evaluated in hematologic malignancies including diffuse large B-cell lymphoma, myelodysplasia, myelofibrosis, adenoid cystic carcinoma, mantle cell lymphoma, acute myeloid leukemia, and chronic myelomonocytic leukemia.
PRT543 is being developed by Prelude Therapeutics Incorporated, a biopharmaceutical company traded on the NASDAQ under the ticker symbol PRLD. The company is conducting clinical research to evaluate the safety and efficacy of this investigational drug in patients with advanced cancers.
PRT543 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. The Phase 1 study has been completed, and the drug remains under clinical investigation for the treatment of advanced solid tumors and certain hematologic malignancies.
PRT543 has been studied in one clinical trial, identified as NCT03886831. This Phase 1 study, titled 'A Study of PRT543 in Participants With Advanced Solid Tumors and Hematologic Malignancies,' was conducted in the United States and has been completed. The trial enrolled 232 participants aged 18 years and older.
PRT543 is a distinct investigational small molecule developed by Prelude Therapeutics. No alternative names for PRT543 have been reported in the clinical trial data. It is being studied as a monotherapy in an uncontrolled, non-randomized Phase 1 trial for advanced cancers.