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Also known as ZIO-301
indibulin · 4 trials · 3 indications
| Arm | Type | Description |
|---|---|---|
| Single Arm | EXPERIMENTAL | Once Maximum Tolerated Dose (MTD) is determined an expanded cohort will be enrolled to evaluate efficacy. |
| Name | Type | Description |
|---|---|---|
| indibulin | DRUG | indibulin, dose escalation, 200 mg - 600 mg. Taken twice every day. |
| erlotinib | DRUG | erlotinib taken at 150 mg every morning with food. |
Inclusion Criteria: 1. Subjects with advanced, histologically confirmed solid tumors for which no standard therapy exists and for whom treatment with erlotinib is considered medically acceptable. 2. ≥18 years of age 3. ECOG performance score ≤2 4. Eligible subjects MUST have at least one measurable...
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 |
Indibulin is an investigational small molecule being studied for the treatment of advanced cancer, advanced solid tumors, and solid tumors. It has been evaluated in Phase 1 clinical trials in adults with these conditions. It is not an approved therapy and remains in clinical development.
Indibulin is a tubulin inhibitor that targets tubulin proteins, specifically TUBB4B, TUBB1, TUBA3C, TUBA4A, TUBB3, and TUBA1A. By binding these targets, it interferes with microtubule function in cancer cells. This mechanism underlies its investigation as an oncology therapeutic.
Indibulin is being developed by Alaunos Therapeutics, Inc., which trades under the ticker TCRT. The company is the sponsor associated with the clinical development of this small molecule oncology candidate.
Indibulin is in Phase 1 clinical development. It is investigational and has not been approved by the FDA. All reported trials of indibulin were Phase 1 studies, and no active trials are currently listed.
Indibulin has been studied in Phase 1 trials including NCT00591890, which used PET scans in advanced cancer; NCT00591383, combining indibulin with erlotinib in advanced solid tumors; NCT00591292 in advanced solid tumors; and NCT00591136 in patients with solid tumors. All are completed.
Across the reported indibulin clinical trials, total enrollment is 69 patients. The studies were Phase 1, uncontrolled, and non-randomized, conducted in the United States and the Netherlands in adults with advanced cancer or solid tumors.