ELVN-001-105 = ELVN-001 for the Treatment of Chronic Myeloid Leukemia With and Without T315I Mutation in Japanese patients [Japan]

What is the purpose of the study

This is a study to evaluate the safety, tolerability and determine the recommended dose for further clinical evaluation of ELVN-001 in Japanese patients with CML in chronic phase with or without T315I mutations in patients who have failed or are intolerant to at least 2 prior tyrosine kinase inhibitors (TKIs) or who are not eligible to receive TKI treatment.

What will happen during the study

This is the first trial to investigate ELVN-001 in humans.

ELVN-001 is a new drug under investigation for the treatment of CML. ELVN-001 will be given orally (by mouth) once daily. The dose will be escalated to determine the recommended dose for further evaluation in patients with chronic phase CML with and without T315I mutations.

This is a study to assess the safety and tolerability of ELVN-001 in Japanese patients with CML. Changes in BCR-ABL1 transcript will be evaluated. The study also assesses how the body interacts with ELVN-001. In scientific terms, this is called pharmacokinetics.

Key inclusion criteria

This study includes patients of all sexes who:

• are aged 18 years or older
• have been diagnosed with BCR-ABL1 positive CML in chronic phase (CP), with or without T315I mutation
• who have failed or are intolerant to previous treatment with at least 2 tyrosine kinase inhibitors (TKIs) or are not a candidate for TKI treatment.
• have an Eastern Co-Operative Group (ECOG) status of 0, 1 or 2
• were born in Japan and both parents and grandparents are Japanese
• have adequate hematologic, liver and kidney function.

Further criteria may apply. Please discuss these with your doctor or study staff.

Key exclusion criteria

This study does not include patients who:

• have been treated with anti-cancer or anti-CML therapy within 7 days or 5 half-lives, whichever is longer
• have had acute TKI-related pancreatitis within 6 months of study entry, or have active pancreatitis or pancreatic disease due to any cause.

Further criteria may apply. Please discuss these with your doctor or study staff.

Estimated primary completion date

Where can I find additional information

You can find a study description in the US register ClinicalTrials.gov. This is a database provided by the U. S. National Institutes of Health.

Study centers / principal investigators

Japan

Akita-ken
Akita-shi, Akita-ken
Akita University Hospital

Hokkaido
Sapporo, Hokkaido
Aiiku Hospital

Osaka
Suita-shi, Osaka
Osaka University Hospital

Tokyo (not yet recruiting)
Shinjuku-ku, Tokyo
Tokyo Medical University Hospital