Date: 2015-09-24
Type of information: Initiation of the trial
phase: 2
Announcement: initiation of the trial
Company: Janssen Biotech, a J&J company (USA - NJ)
Product: talacotuzumab (JNJ-56022473)
Action
mechanism: monoclonal antibody. Talacotuzumab (JNJ-56022473) is an anti CD123 monoclonal antibody
Disease: acute myeloid leukemia (AML)
Therapeutic area: Cancer - Oncology
Country: Australia, Belgium, Germany, Israel, Republic of Korea, Poland, Russian Federation, Spain, Sweden, Taiwan, Turkey, UK, USA
Trial
details: The primary objective of study Part A is to assess the safety of talacotuzumab (formerly CSL362) monotherapy and confirm the recommended Phase 2 dose (RP2D) in participants with acute myeloid leukemia (AML) for whom experimental therapy is appropriate. The primary objective of study Part B are to assess complete response (CR) rate and overall survival (OS) in participants with AML who are not eligible for intense induction chemotherapy and who are randomly assigned to receive decitabine plus talacotuzumab at the RP2D or decitabine alone. ( NCT02472145)
Latest
news: * On September 24, 2015, Xencor announced that its partner CSL has initiated, through its licensee Janssen Biotech, a Phase 2 clinical trial for CSL362 (now called JNJ-56022473), which uses Xencor's XmAb® Cytotoxic Fc Domain. Xencor will receive an undisclosed milestone payment for the initiation of Phase 2 testing. Under the terms of the agreement signed in February 2009, Xencor granted CSL a non-exclusive license to Xencor Cytotoxic Fc Domains for use in CSL programs, including CSL362. Xencor is also eligible to receive additional milestone payments and royalties on sales. In 2013, CSL licensed CSL362 to Janssen Biotech.
