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Also known as Ningetinib
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 | 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 |
CT053PTSA, also known as ningetinib, is an investigational small molecule being studied for the treatment of advanced solid tumors and non-small cell lung cancer. It is currently in Phase 1 clinical development and is not yet approved by regulatory authorities.
CT053PTSA is a small molecule tyrosine kinase inhibitor. It is being studied in combination with gefitinib in patients with EGFR-mutated non-small cell lung cancer who are T790M negative, suggesting it targets pathways involved in tumor growth and resistance.
CT053PTSA is being developed by Sunshine Biopharma Inc., a biopharmaceutical company. The company is conducting clinical trials for this investigational drug in oncology indications.
CT053PTSA is in Phase 1 clinical development. Two Phase 1 trials have been completed, one in advanced solid tumors and one in non-small cell lung cancer. The drug remains investigational and has not received regulatory approval.
CT053PTSA has been studied in two completed Phase 1 trials: NCT03758287, which evaluated ningetinib plus gefitinib in stage IIIB or IV non-small cell lung cancer patients with EGFR mutation and T790M negative status, and NCT04577703, a first-in-human trial in patients with advanced solid tumors.
Yes, CT053PTSA is also known as ningetinib. Both names refer to the same investigational small molecule drug being developed by Sunshine Biopharma Inc. for the treatment of advanced solid tumors and non-small cell lung cancer.