Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
PTC596 · 1 trial · 1 indication
Determine the RP2D based on occurrence of DLTs and/or biological efficacy as determined by biomarker changes.
| Arm | Type | Description |
|---|---|---|
| Cohort 1 | EXPERIMENTAL | PTC 596 administered twice daily- Dose level 0.65mg/kg |
| Cohort 2 | EXPERIMENTAL | PTC 596 administered twice daily-Dose level 1.3mg/kg |
| Cohort 3 | EXPERIMENTAL | PTC 596 administered twice daily-2.6mg/kg |
| Cohort 4 | EXPERIMENTAL | PTC 596 administered twice daily-Dose level 5.2mg/kg |
| Cohort 5 | EXPERIMENTAL | PTC 596 administered twice daily-Dose level 10mg/kg |
| Cohort 6 | EXPERIMENTAL | PTC 596 administered twice daily-Dose level 7mg/kg |
| Cohort 7 (Bio Marker cohort) | EXPERIMENTAL | PTC 596 administered twice daily-Dose level 5.2mg/kg |
| Name | Type | Description |
|---|---|---|
| PTC596 | DRUG | PTC 596 will be administered orally twice a day until unmanageable toxicity, disease progression, or withdrawal of consent is noted |
Inclusion Criteria: * Patients must have histologically or cytologically confirmed solid malignancy that is metastatic or unresectable, for which standard curative measures do not exist, that has progressed on at least one line of standard therapy or for which no standard therapies exists * Discont...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| GE Healthcare Technologies Inc. | GEHC | 1 | PHASE1 | GEH200520/ GEH200521- Part A |
| Zimmer Biomet Holdings, Inc. | ZBH | 1 | - | Undisclosed |
| Ascentage Pharma Group International Unsponsored ADR | AAPG | 1 | PHASE1 | Olverembatinib |
PTC596 is an investigational small molecule being developed for the treatment of cancer. It is being studied in patients with advanced solid tumors. The drug is currently in clinical development and has not been approved by regulatory authorities.
PTC596 is being developed by PTC Therapeutics, Inc., a biopharmaceutical company. The company's stock is traded under the ticker symbol PTCT. PTC Therapeutics is conducting clinical trials to evaluate the safety and efficacy of PTC596 in cancer patients.
PTC596 is in Phase 1 clinical development. A Phase 1 trial has been completed, which involved 31 patients with advanced solid tumors. The drug is still investigational and has not received regulatory approval for any indication.
PTC596 has been studied in one clinical trial with the identifier NCT02404480, titled 'PTC596 in Patients With Advanced Solid Tumors'. This Phase 1 study was completed and enrolled 31 participants in the United States and Canada. The trial included adult patients aged 18 years and older.
PTC596 is not FDA approved. It is an investigational drug that has completed a Phase 1 clinical trial for advanced solid tumors. The drug remains in clinical development, and its safety and efficacy have not been established for regulatory approval.