Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
TKM-080301 · 2 trials · 9 indications
Laboratory assessments
| Arm | Type | Description |
|---|---|---|
| Phase 1 Escalation / Phase 2 Expansion | EXPERIMENTAL | Phase 1 - dose escalation with intravenous infusion of TKM-080301 to determine MTD. Phase 2 - dose expansion at the MTD. |
| TKM-080301 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| TKM-080301 | DRUG | TKM-080301 intravenous infusion |
Key Inclusion Criteria: * Child-Pugh class of A * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤5.0 × ULN * Total bilirubin ≤3.0 mg/dL * Platelets ≥75,000 /mL * International Normalized Ratio (INR) ≤1.7 ...
Top 2 of 3 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 |
TKM-080301 is an investigational therapy that has been studied in cancer, including hepatocellular carcinoma, neuroendocrine tumors, and adrenocortical carcinoma. It was evaluated in Phase 1 clinical trials in adults with advanced solid tumors. It is not an approved treatment and remains in clinical development.
TKM-080301 targets PLK1, a protein involved in cell division. PLK1 is a serine/threonine kinase that regulates mitosis, and blocking it is intended to interfere with tumor cell proliferation. This mechanism underlies its investigation in oncology indications such as hepatocellular carcinoma.
TKM-080301 is being developed by Arbutus Biopharma Corporation, which trades under the ticker ABUS. The company has sponsored the clinical trials evaluating the agent in cancer indications, including hepatocellular carcinoma and neuroendocrine tumors.
TKM-080301 is in Phase 1 clinical development. It has completed Phase 1 trials in advanced hepatocellular carcinoma and in neuroendocrine tumors and adrenocortical carcinoma. It is an investigational agent and has not been approved for any indication.
TKM-080301 has been studied in two completed Phase 1 trials. NCT02191878 evaluated intravenous TKM-080301 in advanced hepatocellular carcinoma across the United States, Canada, China, Singapore, South Korea, and Taiwan. NCT01262235 was a dose-finding study in neuroendocrine tumors and adrenocortical carcinoma conducted in the United States.
No. TKM-080301 is an investigational drug and is not FDA approved. It has completed Phase 1 clinical testing in cancer indications, including hepatocellular carcinoma and neuroendocrine tumors, and remains in clinical development under Arbutus Biopharma Corporation.