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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 being studied for the treatment of breast cancer. It is also being evaluated in other advanced or metastatic solid tumors, including glioblastoma, head and neck squamous cell carcinoma, malignant mesothelioma, non-small cell lung cancer, sarcoma, and endometrial cancer.
PRT3645 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 or metastatic solid tumors.
PRT3645 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still undergoing clinical trials to assess its safety and effectiveness in patients with select advanced or metastatic solid tumors, including breast cancer.
PRT3645 has been studied in a Phase 1 clinical trial with the identifier NCT05538572. This trial, titled 'A Study of PRT3645 in Participants With Select Advanced or Metastatic Solid Tumors,' enrolled 22 participants and has been completed. The study was conducted in the United States and Singapore.
PRT3645 is a distinct investigational small molecule developed by Prelude Therapeutics. No alternative names for PRT3645 have been disclosed in the clinical trial information. It is being studied as a monotherapy in an uncontrolled, non-randomized Phase 1 trial for advanced or metastatic solid tumors.