Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
indibulin · 2 trials · 2 indications
| Arm | Type | Description |
|---|---|---|
| Single Arm | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| indibulin | DRUG | dose escalation of indibulin given twice daily for 21 days, to be repeated every 28 days. |
Inclusion Criteria: 1. Histological or cytological confirmation of advanced cancer, refractory to standard therapies. 2. Received at least one prior therapy and requires additional treatment. 3. ≥18 years of age. 4. ECOG performance score ≤ 2 (see Appendix 3). 5. At least one measurable lesion as d...
| 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 |
Indibulin is an investigational small molecule being studied for the treatment of solid tumors and advanced cancer. It is in Phase 1 clinical development and has not been approved by the FDA. Two Phase 1 trials have been completed, one in patients with solid tumors and another in patients with advanced cancer.
Indibulin is being developed by Alaunos Therapeutics, Inc., a biopharmaceutical company traded on the stock exchange under the ticker symbol TCRT. The company is conducting clinical research to evaluate the safety and efficacy of indibulin in oncology indications.
Indibulin is in Phase 1 clinical development. Two Phase 1 studies have been completed, one in patients with solid tumors and another in patients with advanced cancer. The drug remains investigational and is not yet approved for any use.
Indibulin has been studied in two completed Phase 1 clinical trials. The first, NCT00591136, enrolled 47 patients with solid tumors in the Netherlands. The second, NCT00591890, enrolled 20 patients with advanced cancer in the United States and used PET scans to evaluate the drug.
No, indibulin is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. Clinical trials have been completed to evaluate its safety and potential efficacy in patients with solid tumors and advanced cancer, but it has not received regulatory approval.