A Study of Safety, Pharmacokinetics and Pharmacodynamics of JNJ-64457107 in Participants With Advanced Stage Tumors

Summary

The primary purpose of the study is to determine the recommended Phase 2 dose (RP2D) and schedule of JNJ-64457107 when administered intravenously (IV) to participants with advanced stage solid tumors in Part 1 and to further characterize the safety of JNJ-64457107 when administered IV to participants with non-small cell lung cancer (NSCLC), pancreatic cancer and cutaneous melanoma in Part 2.

Timeline

Start

2016-09-21

Primary completion

2021-07-01

Completion

2021-07-29

Publications

• Andersson H, Sobti A, Jimenez DG, de Coana YP, Ambarkhane SV, Hagerbrand K, Smith KE, Lindstedt M, Ellmark P. Early Pharmacodynamic Changes Measured Using RNA Sequencing of Peripheral Blood from Patients in a Phase I Study with Mitazalimab, a Potent CD40 Agonistic Monoclonal Antibody. Cells. 2023 Sep 27;12(19):2365. doi: 10.3390/cells12192365.
• Moreno V, Perets R, Peretz-Yablonski T, Fourneau N, Girgis S, Guo Y, Hellemans P, Verona R, Pendas N, Xia Q, Geva R, Calvo E. A phase 1 study of intravenous mitazalimab, a CD40 agonistic monoclonal antibody, in patients with advanced solid tumors. Invest New Drugs. 2023 Feb;41(1):93-104. doi: 10.1007/s10637-022-01319-2. Epub 2022 Dec 20.

Drugs

Indications