Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
CT053PTSA · 2 trials · 2 indications
The maximum tolerated dose (MTD) of the CT053PTSA and gefitinib combination will be determined according to incidence of dose-limiting toxicity (DLT) assessed by NCI CTCAE v4.03
Overall response rate (ORR), defined as a partial response (PR) or complete response (CR) occurring at any point post-treatment according to Response Evaluation Criteria in Solid Tumors as assessed by RECIST v1.1
The maximum tolerated dose (MTD) of the CT053PTSA will be determined according to incidence of dose-limiting toxicity (DLT) assessed by NCI CTCAE v4.0
| Arm | Type | Description |
|---|---|---|
| CT053PTSA +Gefitinib | EXPERIMENTAL | Patients will receive CT053PTSA and gefitinib over a 28-day cycle until progressive disease, intolerable toxicity or subject's withdrawal from treatment. CT053PTSA will be administered daily, at a dose of 30 mg/40mg/60mg orally . Gefitinib will be administered daily, at a dose of 250 mg orally . |
| CT053PTSA (dose escalation) | EXPERIMENTAL | Patients were treated in 5 dose cohorts of 15 mg, 30 mg, 60 mg, 100 mg, and 150 mg QD capsules. Patients receive treatment with CT053PTSA once on Cycle 0 Day 1 following a 7-day treatment-free withdrawal period to observe the safety and pharmacokinetic of CT053PTSA. After that, Patients receive treatment with CT053PTSA per orally, beginning on Cycle 1 Day 1 for 28 day following a 7-day treatment-free withdrawal period to observe efficacy of CT053PTSA and determine to continue taking medicine or not. Each cycle had 28 days. |
| Name | Type | Description |
|---|---|---|
| CT053PTSA | DRUG | - |
| Gefitinib | DRUG | - |
Inclusion Criteria: * Histologically or cytologically confirmed Stage IIIB or IV NSCLC * Resistance to EGFR TKI (1st, 2nd or 3rd generation) * Histological or cytological evidence of EGFR mutation and T790M negative after progression on last EGFR TKI therapy * c-Met GCN ≥ 6 or cluster amplification...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Merck & Co., Inc. | MRK | 2 | PHASE2 | pembrolizumab |
| Incyte Corporation | INCY | 1 | PHASE2 | Chemotherapy, Retifanlimab |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | E7 TCR-T cells, Aldesleukin |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115, pembrolizumab |
| AstraZeneca PLC | AZN | 1 | - | Trastuzumab deruxtecan |
CT053PTSA, also known as Ningetinib, is an investigational small molecule being studied for the treatment of Non-small Cell Lung Cancer and Advanced Solid Tumors. It is currently in Phase 1 clinical development.
CT053PTSA is a small molecule, but its specific molecular target has not been disclosed in the available information. It is being investigated for its potential anti-cancer activity in Non-small Cell Lung Cancer and Advanced Solid Tumors.
CT053PTSA is being developed by Sunshine Biopharma Inc., a company listed on the stock exchange under the ticker symbol SBFM.
CT053PTSA is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Two Phase 1 trials have been completed.
CT053PTSA has been studied in two completed Phase 1 trials. NCT03758287 evaluated Ningetinib plus Gefitinib in stage IIIB or IV NSCLC patients with EGFR mutation and T790M negative, enrolling 108 participants. NCT04577703 was a first-in-human trial in patients with advanced solid tumors, enrolling 20 participants.
Yes, CT053PTSA is also known as Ningetinib. Both names refer to the same investigational drug being developed by Sunshine Biopharma Inc.