A Phase 1 clinical study of nemtabrutinib in Japanese participants with hematological malignancies

JRCT ID: jRCT2031220583

Registered date:22/01/2023

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: mature B-cell neoplasms
• Date of first enrollment: 13/02/2023
• Target sample size: 12
• Study type: Interventional
• Intervention(s): This study performs dose escalation of nemtabrutinibat each predetermined dose levels (45 mg QD or 65 mg QD).

Outcome(s)

Primary Outcome

- Dose limiting toxicities
- Adverse events(AEs)
- Discontinuing study treatment due to AEs

Secondary Outcome

- PK parameters including AUC, Cmax, Tmax and Cmin in plasma
- Objective response
- Duration of response

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

- Histologically confirmed B-cell malignancy:
*Chronic lymphocytic leukemia (CLL)
*Small lymphocytic lymphoma (SLL)
*Waldenstrom's macroglobulinemia (WM)
*Lymphoplasmacytic lymphoma (LPL)
*Other B-cell neoplasm
- Failed or intolerant to either at least 2 prior regimens given in combination or sequentially OR have received 1 prior Bruton's tyrosine kinase (BTK)-containing regimen when a BTK inhibitor is approved as first line therapy
- Have the ability to swallow and retain oral medication
- Is Japanese

Exclude criteria

- Active Hepatitis B virus (HBV)/Hepatitis C virus (HCV) infection at study entry
- History of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 3 years
- Known history of human immunodeficiency virus (HIV) infection
- Clinically significant gastrointestinal abnormalities that might alter absorption (eg, gastric bypass surgery,gastrectomy)
- Underlying history of severe bleeding disorders
- History or concurrent condition of pneumonitis/interstitial lung disease

Related Information

• Primary Sponsor: Koh Yasuhiro