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PRT2527 · 2 trials · 17 indications
Dose limiting toxicities will be evaluated during Cycle 1 depending on the treatment arm and intrapatient ramp-up.
Safety and tolerability will be evaluated by incidence of DLTs, dose interruption, modification, and discontinuation due to adverse events (AEs) according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)
The MTD/RP2D will be established for further investigation in participants with relapsed or refractory hematologic malignancies
Dose limiting toxicities will be evaluated over the 21-day observation period
The MTD will be established for further investigation in participants with advanced solid tumors
The RP2D will be established for further investigation in participants with advanced solid tumors
| Arm | Type | Description |
|---|---|---|
| PRT2527 Monotherapy in Lymphoid Malignancies | EXPERIMENTAL | PRT2527 will be administered by intravenous infusion once weekly at the dose level assigned during the dose escalation phase and at the defined RP2D dose for indication-specific cohorts during the dose confirmation phase. |
| PRT2527/Zanubrutinib Combination in Lymphoid Malignancies | EXPERIMENTAL | PRT2527 will be administered by intravenous infusion once weekly at the dose level assigned during the dose escalation phase and at the defined RP2D dose for indication specific cohort during the dose confirmation phase. Zanubrutinib will be administered orally as combination therapy once or twice daily. |
| PRT2527 Monotherapy in Myeloid Malignancies | EXPERIMENTAL | PRT2527 will be administered by intravenous infusion once weekly at the dose level assigned during the dose escalation phase and at the defined RP2D dose for indication-specific cohorts during the dose confirmation phase. |
| PRT2527/Venetoclax Combination in Myeloid Malignancies | EXPERIMENTAL | PRT2527 will be administered by intravenous infusion once weekly at the dose level assigned during the dose escalation phase and at the defined RP2D dose for indication specific cohort during the dose confirmation phase. Venetoclax will be administered orally as a combination therapy once daily. |
| PRT2527 | EXPERIMENTAL | PRT2527 will be administered by intravenous infusion |
| Name | Type | Description |
|---|---|---|
| PRT2527 | DRUG | PRT2527 will be administered by intravenous infusion once weekly. |
| Zanubrutinib | DRUG | Zanubrutinib will be provided in capsules for oral administration once or twice daily. |
| Venetoclax | DRUG | Venetoclax will be provided in tablet for oral administration once daily |
Inclusion Criteria: * Willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures * Histologically or cytologically confirmed diagnosis of aggressive B-cell lymphoma subtypes, MCL, MZL, or CLL/SLL (including Richter's ...
PRT2527 is an investigational small molecule being studied for aggressive B-Cell Non-Hodgkin's Lymphoma (NHL) and sarcoma. It has also been evaluated in other advanced solid tumors and hematologic malignancies, including chronic lymphocytic leukemia, mantle cell lymphoma, and acute myeloid leukemia, though these are not the primary focus.
PRT2527 is a small molecule oncology drug. The specific molecular target has not been disclosed in available clinical trial information. It is being studied across multiple tumor types, suggesting a potentially broad mechanism of action relevant to cancer cell biology.
PRT2527 is being developed by Prelude Therapeutics Incorporated, a biopharmaceutical company traded on NASDAQ under the ticker PRLD. The company is conducting clinical trials of PRT2527 in oncology indications.
PRT2527 is in Phase 1 clinical development. Two Phase 1 trials have been completed, one in advanced solid tumors and one in hematologic malignancies. The drug remains investigational and has not been approved by regulatory authorities.
PRT2527 has been studied in two completed Phase 1 trials. NCT05159518 evaluated PRT2527 in participants with advanced solid tumors including sarcoma. NCT05665530 studied PRT2527 as monotherapy and in combination with zanubrutinib or venetoclax in participants with relapsed or refractory hematologic malignancies.
PRT2527 is the sole name used for this investigational drug in clinical trial registrations. No alternative names or aliases have been identified in the available information, so it is not known to be the same as any other marketed or investigational compound.