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
- Conditions
- Chronic Lymphocytic LeukemiaB-cell non-Hodgkin lymphoma & chronic lymphocytic leukemia10025320
- Registration Number
- NL-OMON52350
- Lead Sponsor
- Janssen-Cilag
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 2
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)
<= 480 milliseconds
4. Participants with B cell non-Hodgkin lymphoma (NHL) must have tumor tissue
available at baseline as described in the protocol. This is not required for
participants with chronic lymphocytic leukemia (CLL)
5. Women of childbearing potential must agree to use a barrier method of
contraception; use a highly effective preferably user-independent method of
contraception; not to donate eggs (ova, oocytes) or freeze them for future use
for the purposes of assisted reproduction during the study; not to plan to
become pregnant; and not to breastfeed
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]).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Part A (Dose Escalation) Determine the recommended Phase 2 doses (RP2Ds) of<br /><br>JNJ-64264681 and JNJ-67856633 when administered together in participants with B<br /><br>cell NHL and CLL<br /><br>Part B (Cohort Expansion) Determine the safety of the RP2D(s) for this<br /><br>combination in different histologies/ participant populations</p><br>
- Secondary Outcome Measures
Name Time Method <p>Assess the PK of JNJ-64264681 and JNJ-67856633 when administered together<br /><br>Assess the PD of JNJ-64264681 and JNJ-67856633 when administered together<br /><br>Assess the preliminary clinical activity of JNJ-64264681 and JNJ-67856633 when<br /><br>administered together</p><br>