In short
Tambiciclib is an investigational cancer drug with no marketing authorisation in these records. It is a small-molecule cyclin-dependent kinase 9 (CDK9) inhibitor given by intravenous infusion. One Phase 2 trial is authorised to study tambiciclib in 40 adults with newly diagnosed acute myeloid leukemia (AML) who did not achieve at least a morphologic leukemia-free state after two cycles of venetoclax and azacitidine.
Tambiciclib is an investigational substance with no marketing authorisation in the product records. It is a chemically synthesised small molecule that blocks cyclin-dependent kinase 9 (CDK9), a protein involved in driving the growth of cancer cells. The trial sponsor is IRST IRCCS, and the substance is given as a solution for intravenous infusion.
Key points
- Tambiciclib is an investigational small-molecule CDK9 inhibitor with no marketing authorisation.
- It is being studied in acute myeloid leukemia in one authorised Phase 2 trial.
- The trial plans to enrol 40 participants whose AML did not respond well enough to initial venetoclax plus azacitidine.
- Tambiciclib is given as an intravenous infusion at 30 mg in the trial.
- The main measure is the overall response rate after two courses of treatment.
- The trial is run by IRST IRCCS and is currently authorised but not yet recruiting.
What is tambiciclib?
Tambiciclib is an investigational cancer drug that belongs to the class of antineoplastics and small molecules. It is also known by the development codes GFH-009 and SLS-009. The product records list two formulations: TAMBICICLIB 100 mg/10 mL solution for injection and TAMBICICLIB 100 mg/20 mL solution for injection. Tambiciclib has no marketing authorisation in these records, meaning it is not yet approved as a medicine. The developer is listed as GenFleet Therapeutics, with Sellas Life Sciences Group also involved in its development.
How does tambiciclib work?
Tambiciclib is a cyclin-dependent kinase 9 (CDK9) inhibitor. CDK9 is a protein that helps cancer cells keep growing and survive. By blocking CDK9, tambiciclib aims to interrupt the signals that allow leukemia cells to multiply. This mechanism of action places it among targeted cancer therapies.
Which conditions is tambiciclib being studied for?
- Acute myeloid leukemia (AML) — a fast-growing cancer of the blood and bone marrow. The authorised Phase 2 trial studies tambiciclib in people with newly diagnosed AML who did not achieve at least a morphologic leukemia-free state after their first two cycles of venetoclax and azacitidine.
How is tambiciclib given?
Tambiciclib is prepared as a solution for injection or infusion and is given by intravenous infusion. In the authorised trial, the planned dose is 30 mg given intravenously.
What do the clinical trials show?
One Phase 2 trial of tambiciclib is authorised in the EU Clinical Trials Information System. The trial is open-label and randomised, meaning participants know which treatment they receive and are assigned to a treatment arm by chance. It plans to enrol 40 participants.
Which conditions are studied in the trial?
The trial focuses on newly diagnosed acute myeloid leukemia in people who did not achieve at least a morphologic leukemia-free state after two cycles of venetoclax and azacitidine alone. Tambiciclib is being tested as an add-on to the standard combination of venetoclax and azacitidine.
What is the trial measuring?
The primary outcome is the overall response rate (ORR) after two courses of treatment. ORR combines complete response, complete hematological response, complete response with incomplete hematologic recovery, and morphologic leukemia-free state, assessed according to the ELN 2022 criteria.
Who can take part in the trial?
The trial enrols adults with newly diagnosed AML who have already received two cycles of venetoclax and azacitidine and did not achieve at least a morphologic leukemia-free state. The trial status is authorised, meaning it has received regulatory approval but is not yet recruiting.
What side effects are known?
The supplementary source does not provide a list of side effects for tambiciclib. The trial registry record does not report adverse events for this substance.