A Study of JNJ-64264681 in Participants With Non-Hodgkin Lymphoma and Chronic Lymphocytic Leukemia

Janssen (J&J Innovative Medicine)

Status and phase: Active, not recruiting; Phase 1

Conditions: Lymphoma, Non-Hodgkin; Leukemia, Lymphocytic, Chronic, B-Cell

Treatments: Drug: JNJ-64264681

Study type: Interventional

Funder types: Industry

Identifiers

NCT04210219

CR108706

2019-003194-25 (EudraCT Number)

64264681LYM1001 (Other Identifier)

Details and patient eligibility

About

The purpose of the study is to determine the recommended Phase 2 dose(s) (RP2D[s]) in B cell non-Hodgkin lymphoma (NHL) and chronic lymphocytic leukemia (CLL) in Part 1 and to evaluate the safety of JNJ-64264681 at the RP2D(s) in Part 2.

Enrollment: 85 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participants must have Eastern Cooperative Oncology Group (ECOG) performance status grade of 0 or 1
• Participants must have cardiac parameters within the following range: corrected QT interval (QTcF) less than or equal to <= 480 milliseconds based on the average of triplicate assessments performed as close as possible in succession (the full set of triplicates should be completed in less than 10 minutes)
• Women of childbearing potential must have a negative highly sensitive serum pregnancy test (example: beta human chorionic gonadotropin [beta-hCG]) at screening, and a negative serum or urine pregnancy test prior to the first dose of study drug
• Women must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for a period of at least 30 days after the last study drug administration
• Participants must be willing and able to adhere to the lifestyle restrictions specified in this protocol

Exclusion criteria

• Participant has known active central nervous system (CNS) involvement
• Participant has received prior solid organ transplantation
• Participant has known allergies, hypersensitivity, or intolerance to JNJ-64264681 or its excipients
• Participant has been treated with an investigational drug (including investigational vaccines) within five half-lives or 2 weeks before the planned first dose of study drug
• Participant is experiencing toxicities from previous anticancer therapies that have not resolved to baseline levels, or to Grade 1 or less (except for alopecia and peripheral neuropathy)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Sequential Assignment

Masking: None (Open label)

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85 participants in 1 patient group

JNJ-64264681: Dose Escalation and Expansion

Experimental group

Description:

Participants will receive oral administration of JNJ-64264681 capsule at a dose assigned by the sponsor Study Evaluation Team (SET), based on the available safety, pharmacokinetics, and pharmacodynamics data in dose escalation treatment group (Part 1); and recommended Phase 2 dose (RP2D) determined in Part 1 in cohort expansion treatment group (Part 2).

Treatment:

Drug: JNJ-64264681