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AZD8055 · 3 trials · 4 indications
| Arm | Type | Description |
|---|---|---|
| AZD8055 | EXPERIMENTAL | Dose escalation |
| 1 | EXPERIMENTAL | The study will start with AZD8055 formulated in a liquid solution prior to the tablet formulation becoming available. The tablet formulation will be introduced in Part A at the beginning of a new cohort at an appropriate dose, no higher than the dose of the liquid formulation in the last completed evaluated cohort. Oral solution or tablet, single dose on Day 1 Part A, twice daily ascending dosing from day 8 onwards (until maximum tolerated dose is reached), cycles of 28 days treatment. |
| Name | Type | Description |
|---|---|---|
| AZD8055 | DRUG | Dose escalation phase: Tablet taken orally, a single dose of AZD8055 on Day 1, followed by twice daily continuous dosing from Day 3 onwards, till discontinuation or withdrawal.Expansion phase: twice daily continuous dosing from Day 1 onwards till discontinuation or withdrawal. |
Inclusion Criteria: * Advanced stage Hepatocellular Carcinoma (HCC) confirmed by cytology or histology * Advanced stage Hepatocellular Carcinoma (HCC) or metastatic Hepatocellular Carcinoma (HCC) which is inoperable and incurable with standard available treatments * Relatively good overall health o...
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 |
AZD8055 is an investigational small molecule being studied for the treatment of cancer, including advanced solid tumors and advanced hepatocellular carcinoma (liver cancer). It is not an approved therapy and remains in clinical development. All reported studies of AZD8055 have been Phase 1 trials in patients with advanced malignancies.
AZD8055 targets MTOR, the mechanistic target of rapamycin. It is an MTOR inhibitor, meaning it acts on this kinase to interfere with signaling pathways that drive tumor cell growth and proliferation. This mechanism underlies its investigation as an anticancer agent in solid tumors and liver cancer.
AZD8055 is developed by AstraZeneca PLC, which trades under the ticker AZN. The company sponsored the Phase 1 clinical studies of the compound in patients with advanced solid tumors and hepatocellular carcinoma across sites in the United States, Europe, and Asia.
AZD8055 is in Phase 1 clinical development. It is investigational and has not been approved by the FDA or any other regulatory agency. All three recorded trials were Phase 1 studies, and each has been completed, with no active trials currently listed for the compound.
AZD8055 has been evaluated in three completed Phase 1 trials: NCT00731263 in advanced solid tumors across the United States, France, and the United Kingdom; NCT00999882 in advanced hepatocellular carcinoma in Hong Kong and South Korea; and NCT00973076 in advanced solid malignancies in Japan. All three studies are now completed.
The AZD8055 clinical program enrolled patients across three completed Phase 1 studies. NCT00731263 enrolled 64 patients with solid tumors, NCT00999882 enrolled 26 patients with advanced hepatocellular carcinoma, and NCT00973076 enrolled 19 patients with advanced solid malignancies in Japan. All trials were uncontrolled and non-randomized.