Date: 2017-02-07
Type of information: Initiation of the trial
phase: 1
Announcement: initiation of the trial
Company: Actinium Pharmaceuticals (USA - NJ) Baylor Research Institute,
Product: Actimab-A - Lintuzumab-Ac225
Action
mechanism: monoclonal antibody/radioimmunotherapy. Actimab-A is a radiolabeled antibody being developed for newly diagnosed AML in patients over 60, and is currently in a multicenter Phase 1/2 clinical trial. Actimab-A consists of the monoclonal antibody, HuM195, and the radioisotope, actinium-225. Actinium-225 decays by giving off high-energy alpha particles, which kill cancer cells. When actinium decays, it produces a series of daughter atoms, each of which gives off its own alpha particle, increasing the chances that the cancer cell will be destroyed. HuM195 is the humanized version of M195 and is a monoclonal antibody that targets CD33, which is abundantly found on myeloid leukemia cells. Both the alpha particle technology and HuM195 were initially developed at Memorial Sloan Kettering Cancer Center.
Disease: refractory multiple myeloma
Therapeutic area: Cancer - Oncology
Country: USA
Trial
details: This phase I study of 225Ac-lintuzumab in patients with multiple myeloma progressing after 3 prior Anti-MM regimens or rfractory to QUAD (Carfilzomib, Lenalidomide, Pomalidomide, and Dexamethasone) aims to establish the MTD of fractionated doses of Lintuzumab-Ac225 as monotherapy. 2. Establish overall response rate (ORR) where ORR = CR + sCR+ VGPR+PR) 3. Confirm the safety profile of the treatment regimen 4. Determine changes in plasmocyte, T-cell and MDSC cell populations 5. Estimate progression-free survival (PFS) and overall survival. (NCT02998047)
Latest
news: * On February 7, 2017, Actinium Pharmaceuticals announced that a Phase 1 clinical trial studying Actimab-M in multiple myeloma has been initiated. Actimab-M is comprised of the CD-33 targeting monoclonal antibody HuM-195 coupled to the alpha-particle emitter actinium 225. CD33 is an antigen found on hematopoietic cells in myeloid malignancies including AML, but recent research has shown that CD33 can also be found on malignant cells of approximately 25%-35% of all multiple myeloma patients. Furthermore, the expression of this marker increases in relapsed and refractory myeloma. In addition, it predicts for a very aggressive course of disease. This makes CD33 a potential target for the treatment of this usually fatal disease. In this new trial, Actimab-M will be used in patients who have progressing disease after 3 prior multiple myeloma treatment regimens or are refractory to QUAD (Carflizomib, Lenalidomide, Pomalidomide, Dexamethasone).
