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PRT3789 · 1 trial · 4 indications
Dose limiting toxicities will be evaluated over the 21-day observation period
Safety and tolerability will be evaluated by incidence of DLTs, laboratory measurements, 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 advanced solid tumors
| Arm | Type | Description |
|---|---|---|
| PRT3789 Monotherapy | EXPERIMENTAL | PRT3789 will be administered by intravenous infusion |
| PRT3789/Docetaxel Combination | EXPERIMENTAL | PRT3789 and Docetaxel will be administered by intravenous infusions |
| Name | Type | Description |
|---|---|---|
| PRT3789 | DRUG | PRT3789 will be administered by intravenous infusion |
| Docetaxel | DRUG | Docetaxel will be administered by intravenous infusion |
Inclusion Criteria: * Willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations (including contraception requirements), and other study procedures * Histologically confirmed advanced, recurrent, or metastatic solid tumor malignancy with any mut...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Merck & Co., Inc. | MRK | 2 | PHASE2 | Pembrolizumab, Gardasil 9 |
| Incyte Corporation | INCY | 1 | PHASE2 | Retifanlimab |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | Aldesleukin |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115 |
| AstraZeneca PLC | AZN | 1 | - | Trastuzumab deruxtecan |
PRT3789 is an investigational small molecule being studied for advanced or metastatic solid tumors, including non-small cell lung cancers, in participants whose tumors carry a SMARCA4 gene mutation. It is being developed by Prelude Therapeutics and is not yet approved for any indication.
PRT3789 targets SMARCA2, a protein in the SWI/SNF chromatin remodeling complex. By acting on SMARCA2, the drug is designed to exploit the dependency created when SMARCA4 is mutated, a concept known as synthetic lethality in SMARCA4-mutant cancers.
PRT3789 is being developed by Prelude Therapeutics Incorporated, which trades on the Nasdaq under the ticker PRLD. Prelude Therapeutics is a clinical-stage biopharmaceutical company focused on precision oncology therapies.
PRT3789 is in Phase 1 clinical development. It is an investigational agent and has not been approved by the FDA or any other regulatory authority. The Phase 1 trial has been completed, and the drug remains in early-stage clinical evaluation.
PRT3789 has been evaluated in a single Phase 1 trial, NCT05639751, titled "PRT3789 Monotherapy and in Combo w/Docetaxel in Participants w/Advanced or Metastatic Solid Tumors w/SMARCA4 Mutation." The trial enrolled 135 participants across the United States, France, Netherlands, Singapore, and Spain, and is now completed.