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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 | 3 | PHASE2 | Pembrolizumab, Gardasil 9 |
| Incyte Corporation | INCY | 1 | PHASE2 | Retifanlimab |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115 |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | Aldesleukin |
| 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 cancer, in patients whose tumors carry a SMARCA4 gene mutation. It is being developed as a biomarker-selected therapy, meaning treatment is directed at tumors with this specific genetic alteration.
PRT3789 targets SMARCA2, a protein in the SWI/SNF chromatin remodeling complex. In tumors with SMARCA4 mutations, cancer cells depend on SMARCA2 for survival, so inhibiting this target is intended to exploit that vulnerability. SMARCA2 is a protein target and PRT3789 is a small molecule.
PRT3789 is being developed by Prelude Therapeutics Incorporated, which trades under the ticker PRLD. Prelude is the sponsor of the clinical program evaluating PRT3789 in biomarker-selected advanced solid tumors.
PRT3789 is in Phase 1 clinical development. It is investigational and has not been approved by the FDA. The Phase 1 study has been completed, and the program has evaluated PRT3789 as a monotherapy and in combination with docetaxel.
PRT3789 has been studied in one 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 has been completed.
Yes, PRT3789 has been evaluated both as a monotherapy and in combination with docetaxel. The Phase 1 trial NCT05639751 studied these approaches in participants with advanced or metastatic solid tumors carrying a SMARCA4 mutation, including non-small cell lung cancers.