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PRT3645 · 1 trial · 7 indications
Dose limiting toxicity will be evaluated over the 28-day observation period
Safety and tolerability will be evaluated by incidence of DLTs, laboratory measurements, severity of adverse events (AEs) according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
The MTD/RP2D will be established for further investigation in participants with advanced solid tumors
| Arm | Type | Description |
|---|---|---|
| PRT3645 | EXPERIMENTAL | PRT3645 capsules will be self-administered once daily, continuously, at the dose-level assigned |
| Name | Type | Description |
|---|---|---|
| PRT3645 | DRUG | PRT3645 capsules will be self-administered once daily, continuously, at the dose-level assigned |
Inclusion Criteria: * Histologically confirmed advanced, recurrent, or metastatic solid tumor malignancy that have either progress or ineligible for standard of care therapy: 1. HR+ and HER2- or HR+ and HER2+ breast cancer 2. Recurrent GBM (IDH wild type) or CDKN2A/B homozygous deleted IDH-mut...
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PRT3645 is an investigational small molecule developed by Prelude Therapeutics Incorporated for the treatment of advanced or metastatic solid tumors, including breast cancer. It is a Phase 1 clinical-stage candidate and has not been approved by the FDA. It was studied in a biomarker-selected patient population.
PRT3645 is being studied for the treatment of select advanced or metastatic solid tumors, including breast cancer. It is an investigational therapy in Phase 1 development and is not approved for any indication. Its clinical program enrolled patients with biomarker-selected tumors.
PRT3645 targets CDK4, a kinase involved in cell cycle regulation. CDK4 is part of the cyclin-dependent kinase family, and PRT3645 is a small molecule designed to inhibit this target. Targeting CDK4 is intended to interfere with tumor cell proliferation in advanced solid tumors.
PRT3645 is being developed by Prelude Therapeutics Incorporated, a clinical-stage biopharmaceutical company. Prelude Therapeutics trades on the Nasdaq under the ticker symbol PRLD. The company is the sponsor of the Phase 1 study evaluating PRT3645 in advanced solid tumors.
PRT3645 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA for any indication. The Phase 1 trial evaluating PRT3645 has been completed, and the program enrolled 22 participants.
PRT3645 was evaluated in the Phase 1 trial NCT05538572, titled A Study of PRT3645 in Participants With Select Advanced or Metastatic Solid Tumors. The trial enrolled 22 participants across the United States and Singapore and studied breast cancer along with several other solid tumor types. The study is completed.