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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 developed by Prelude Therapeutics Incorporated (ticker PRLD). It is being studied in oncology, specifically for aggressive B-cell non-Hodgkin's lymphoma (NHL) and sarcoma. It is a Phase 1 clinical-stage candidate and has not been approved by the FDA.
PRT2527 targets CDK9, a protein kinase involved in regulating transcription. By inhibiting CDK9, the drug is designed to interfere with processes that support the growth and survival of cancer cells. CDK9 is the molecular target of PRT2527, and it is being evaluated as a small molecule therapeutic in oncology.
PRT2527 is developed by Prelude Therapeutics Incorporated, which trades on the Nasdaq under the ticker symbol PRLD. Prelude Therapeutics is the sponsor of the clinical trials evaluating PRT2527 in hematologic malignancies and advanced solid tumors.
PRT2527 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. Two Phase 1 trials have been completed: one in relapsed or refractory hematologic malignancies and one in advanced solid tumors.
PRT2527 has been evaluated in two completed Phase 1 trials. NCT05665530 studied PRT2527 as monotherapy and in combination with zanubrutinib or venetoclax in participants with relapsed or refractory hematologic malignancies, enrolling 86 participants. NCT05159518 studied PRT2527 in participants with advanced solid tumors, including sarcoma, enrolling 30 participants.
PRT2527 is being investigated for the treatment of aggressive B-cell non-Hodgkin's lymphoma (NHL) and sarcoma. It is an investigational Phase 1 small molecule and is not approved for any indication. Clinical evaluation has included relapsed or refractory hematologic malignancies and advanced solid tumors.