Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Unesbulin
PTC596 · 3 trials · 3 indications
To determine the maximum tolerated dose (MTD) and dose limiting toxicities (DLTs) of Unesbulin in combination with and following conventional chemotherapy and as maintenance as a capsule (weight-based dosing) and a tablet (fixed dosing). Standard chemotherapy will be comprised of carboplatin and weekly paclitaxel. The DLTs will be based on adverse events that occur during administration of the first 2 cycles of combination Unesbulin and chemotherapy (a cycle = 21 days).
To examine the tolerability of the combination at the MTD of Unesbulinassessed in combination with standard neoadjuvant chemotherapy.
To determine the recommended phase II dose (RP2D) of Unesbulin in combination with standard neoadjuvant chemotherapy.
MTD will be determined using the TITE-CRM for dose-finding. MTD is defined as the dose associated with a target probability of DLT of 0.25.
Determine the RP2D based on occurrence of DLTs and/or biological efficacy as determined by biomarker changes.
| Arm | Type | Description |
|---|---|---|
| Carboplatin/Paclitaxel + PTC596 | EXPERIMENTAL | Carboplatin AUC 6mg/L IV on day 1; Paclitaxel 175mg/m2 IV on day 1; Unesbulin PO, twice a week, on day 1, 4, 8, 11, 15 and 18 per 21-day cycle for the first 3 cycles. |
| Unesbulin and Dacarbazine | EXPERIMENTAL | Participants will receive unesbulin orally twice weekly in combination with dacarbazine IV once every 21 days. The first participant will receive dacarbazine 1000 mg/m\^2 IV every 21 days in combination with unesbulin 200 mg tablet orally twice weekly. For subsequent participants, the dose level at which treatment is initiated will be selected based on the TITE-CRM using the most up to date dose DLT information from all participants previously treated. Participants will receive unesbulin 300 mg twice weekly in combination with dacarbazine in the expansion cohort. Treatment will continue for each participant until evidence of unacceptable toxicity, disease progression, or treatment discontinuation for another reason. |
| 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 |
|---|---|---|
| Unesbulin | DRUG | Unesbulin will be given in combination with carboplatin and paclitaxel for up to 7 cycles depending on which cohort the patient is in. |
| Dacarbazine | DRUG | Dacarbazine will be administered as per the dose and schedule specified in the arm. |
| PTC596 | DRUG | PTC 596 will be administered orally twice a day until unmanageable toxicity, disease progression, or withdrawal of consent is noted |
Inclusion Criteria: * Histologically documented epithelial ovarian, primary peritoneal or fallopian tube carcinoma or high grade serous adenocarcinoma, endometrioid adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma,or adenocarcinoma not otherwise spec...
Top 2 of 4 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| GE Healthcare Technologies Inc. | GEHC | 1 | PHASE1 | GEH200520/GEH200521 |
| 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.