Phase 1b study, JNJ-64052781 with Ibrutinib in B-Cell Malignancies
Research type
Research Study
Full title
A Phase 1b Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of the Combination of JNJ-64052781 with Ibrutinib in Subjects with B-Cell Malignancies
IRAS ID
205977
Contact name
Frank De Beukelaar
Contact email
Sponsor organisation
Janssen Cilag International NV
Eudract number
2016-000721-39
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 7 months, 16 days
Research summary
This research is an open-label, multicenter, Phase 1b study to evaluate the safety, establish an recommended dose, and evaluate the antitumor activity of JNJ-64052781 in combination with ibrutinib in adult subjects with relapsed or refractory B-cell malignancies.
This study will be conducted in 2 parts:
Part 1: Dose Optimization to identify the recommended dose of JNJ-64052781 in combination with ibrutinib. JNJ-64052781 will be administered intravenously (IV); doses from 5 ng/kg up to the maximum tolerated dose (MTD) may be explored. Ibrutinib will be orally administered once daily. Approximately 24 adult subjects with relapsed or refractory diffuse-large B cell lymphoma (DLBCL), follicular cell lymphoma (F), or mantle cell lymphoma (MCL) are anticipated to be enrolled in Part 1.
Part 2: Dose Expansion to further assess the safety, pharmacokinetics, pharmacodynamic, and antitumor activity of JNJ-64052781 in combination with ibrutinib. Approximately 40 subjects will be enrolled according to tumor type into 4 cohorts (10 subjects each) of DLBCL, FL, MCL, and CLL (chronic lymphocytic leukemia ). The dose of JNJ-64052781 will be based on the recommended dose defined in Part 1 as well as emerging safety data from the First In Human Study 64052781LYM1001.The study consists of a Screening Phase, Treatment Phase, End-of-Treatment Visit, and Post-treatment Follow-up Phase. Part 2 of the study will also include a 7-day Run-in Period of ibrutinib.
The end of the study will be defined as 12 months after the last subject has received the first dose of study treatment.REC name
East of England - Cambridge East Research Ethics Committee
REC reference
16/EE/0219
Date of REC Opinion
30 Jun 2016
REC opinion
Further Information Favourable Opinion