A Phase 1b, Open-Label Study of the Safety, Pharmacokinetics, and Pharmacodynamics of JNJ-64264681 in Combination with JNJ-67856633 in Participants with Non-Hodgkin Lymphoma and Chronic Lymphocytic Leukemia

A Phase 1b, Open-Label Study of the Safety, Pharmacokinetics, and Pharmacodynamics of JNJ-64264681 in Combination with JNJ-67856633 in Participants with Non-Hodgkin Lymphoma and Chronic Lymphocytic Leukemia - Phase 1b study with JNJ64264681 and JNJ67856633 in patients with NHL en CLL

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON52350

Enrollment

Registered

2021-03-22

Start date

2022-03-30

Completion date

Unknown

Last updated

2024-04-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Lymphocytic Leukemia B-cell non-Hodgkin lymphoma & chronic lymphocytic leukemia

Interventions

Participants receive the combination JNJ-64264681 (capsule) and JNJ-67856633 (capsule or tablet) daily or twice daily. The dosage will be determined based on the available data.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. >=18 years of age 2. Eastern Cooperative Oncology Group (ECOG) performance status grade of 0 or 1 3. Cardiac parameters within the following range: corrected QT interval (QTcF)

Exclusion criteria

Exclusion criteria: 1. Part A and select cohorts in Part B: Prior treatment with JNJ-64264681 or JNJ-67856633. Previously discontinued treatment with a BTK or MALT inhibitor other than JNJ-64264681 or JNJ-67856633 due to participant or doctor choice without evidence of progression or intolerable class-related toxicity will be eligible. 2. Known (active) CNS involvement for dose escalation and specific expansion cohorts as determined by the SET. 3. Received prior solid organ transplantation. 4. Participant has known allergies, hypersensitivity, or intolerance to JNJ-64264681 or JNJ-6785566 or excipients (refer to the respective IBs). 5. Toxicities from previous anti-cancer therapies that have not resolved to baseline levels, or to Grade <2 (except for alopecia [>=Grade 2], vitiligo [Grade 2] and peripheral neuropathy [Grade 1]).

Design outcomes

Primary

Measure	Time frame
Part A (Dose Escalation) Determine the recommended Phase 2 doses (RP2Ds) of JNJ-64264681 and JNJ-67856633 when administered together in participants with B cell NHL and CLL Part B (Cohort Expansion) Determine the safety of the RP2D(s) for this combination in different histologies/ participant populations	—

Secondary

Measure	Time frame
Assess the PK of JNJ-64264681 and JNJ-67856633 when administered together Assess the PD of JNJ-64264681 and JNJ-67856633 when administered together Assess the preliminary clinical activity of JNJ-64264681 and JNJ-67856633 when administered together	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)