A Study of ONO-7475 in Patients With Acute Leukemias

Recruiting at16 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Ono Pharmaceutical Co. Ltd

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This trial is testing the safety and effectiveness of a new drug, ONO-7475, alone and with another drug, venetoclax, in patients with certain blood cancers that have not responded to other treatments. The drugs work by trying to stop cancer cells from growing and making them die. Venetoclax is used in treating lymphomas and leukemias, but it is known for its severe side effects.

Research Team

Project Leader

Principal Investigator

Ono Pharmaceutical Co. Ltd

Eligibility Criteria

Inclusion Criteria

Patients aged ≥18 years at time of screening.

Written informed consent by the patient (or their legal representative) prior to admission to this study. In addition, any locally required authorization (Health Insurance Portability and Accountability Act in the US), must be obtained from the patient prior to performing any protocol-related procedures, including screening evaluations.

Eastern Cooperative Oncology Group (ECOG) performance status 0-2 as assessed during the screening period and then again anytime during the 2-day period immediately preceding the start of dosing in Parts A and D.

Exclusion Criteria

QT interval corrected according to Fredericia's formula (QTcF) prolongation defined as a QTcF interval >470 msec or other significant ECG abnormalities including second degree (type II) or third degree atrioventricular block or bradycardia (ventricular rate <50 beats/min).

Clinically significant liver disease, including active viral or other hepatitis, current alcohol abuse, or severe cirrhosis.

Human immunodeficiency virus (HIV), active hepatitis B (HBV) or C (HCV) infection.

Treatment Details

Interventions

• ONO-7475 (Other)
• ONO-7475 + venetoclax (Other)

Participant Groups

Group I: ONO-7475 6mg once daily Experimental Treatment 1 Intervention

Part A 2nd dose level

Group II: ONO-7475 6mg + Venetoclax (70-400mg) Experimental Treatment 1 Intervention

Part D ONO-7475 + Venetoclax combination

Group III: ONO-7475 3mg once daily Experimental Treatment 1 Intervention

Part A Initial dose level

Group IV: ONO-7475 10mg once daily Experimental Treatment 1 Intervention

Part A 3rd dose level

Who Is Running the Clinical Trial?

Ono Pharmaceutical Co. Ltd

Lead Sponsor

Trials

182

Recruited

97,100+

Shinji Takai

Ono Pharmaceutical Co. Ltd

Chief Medical Officer since 2023

MD from an unspecified institution

Gyo Sagara

Ono Pharmaceutical Co. Ltd

Chief Executive Officer since 2024

PhD in Pharmaceutical Sciences from Kyoto University