A Study of Voruciclib Alone or in Combination With Venetoclax in Subjects With B-Cell Malignancies or AML

Summary

This is a Phase 1, open-label, dose escalation study to determine the safety and preliminary efficacy of voruciclib monotherapy in subjects with relapsed/refractory B cell malignancies or AML after failure of standard therapies or voruciclib in combination with venetoclax in subjects with relapsed or refractory AML

Timeline

Start

2018-05-31

Primary completion

2024-07-24

Completion

2024-07-24

Outcome

Outcome not reported

Stopped (Business): “Business reasons, not related to safety or efficacy results.”

Publications

• Results Alvarado-Valero Y, Cook RJ, Dinner SN, Keng M, Begna KH, Javidi-Sharifi N, Abedin S, Al Malki MM, Bhatt VR, Rajagopalan P, Tang M, Wiley SE, Ghalie RG, Davids MS. The oral CDK9 inhibitor voruciclib combined with venetoclax for patients with relapsed/refractory acute myeloid leukemia. Blood Neoplasia. 2025 Apr 25;2(3):100108. doi: 10.1016/j.bneo.2025.100108. eCollection 2025 Aug.
• Results Davids MS, Brander DM, Alvarado-Valero Y, Diefenbach CS, Egan DN, Dinner SN, Javidi-Sharifi N, Al Malki MM, Begna KH, Bhatt VR, Abedin S, Cook RJ, Collins MC, Roleder C, Dominguez EC, Rajagopalan P, Wiley SE, Ghalie RG, Danilov AV. A phase 1 study of the CDK9 inhibitor voruciclib in relapsed/refractory acute myeloid leukemia and B-cell malignancies. Blood Adv. 2025 Feb 25;9(4):820-832. doi: 10.1182/bloodadvances.2024014633.

Drugs

Indications