PF-06863135 As Single Agent And In Combination With Immunomodulatory Agents In Relapse/Refractory Multiple Myeloma

MAGNETISMM-1 A PHASE I, OPEN LABEL STUDY TO EVALUATE THE SAFETY, PHARMACOKINETIC, PHARMACODYNAMIC AND CLINICAL ACTIVITY OF ELRANATAMAB (PF-06863135), A B-CELL MATURATION ANTIGEN (BCMA) - CD3 BISPECIFIC ANTIBODY, AS A SINGLE AGENT AND IN COMBINATION WITH IMMUNOMODULATORY AGENTS IN PATIENTS WITH RELAPSED/REFRACTORY ADVANCED MULTIPLE MYELOMA (MM)

To assess the safety and tolerability at increasing dose levels of PF-06863135 in patients with relapse/ refractory multiple myeloma in order to determine the maximum tolerated dose and select the recommended Phase 2 dose.

Study C1071001 is a Phase 1, open label, multi dose, multi center, dose escalation, safety, pharmacokinetic (PK) and pharmacodynamic study of PF-06863135 in adult patients with advanced multiple myeloma who have relapsed from or are refractory to standard therapy. This is a two part study; Part 1 will assess the safety and tolerability of increasing dose levels of PF-06863135 and Part 2 will evaluate safety and anti-myeloma activity of PF-06863135 at the RP2Ds determined in Part 1.

Inclusion Criteria:

• Relapsed/refractory multiple myeloma
• Progressed or are intolerant of established therapies including proteasome inhibitor, immunomodulatory drug, and anti-CD38 antibody
• Performance Status of 0- 1 ( Performance Score 2 is permitted only if due to underlying myeloma)
• Adequate bone marrow, hematological, kidney and liver function
• Resolved acute effects of any prior therapy to baseline severity
• Not pregnant

Exclusion Criteria:

• Recent history of other malignancies
• History of active autoimmune disorders
• Any form of primary immunodeficiency
• Active and clinically significant bacterial, fungal, or viral infection
• Evidence of active mucosal or internal bleeding
• History of severe immune-mediated adverse event with prior immunomodulatory treatment
• Major surgery within 4 weeks of study treatment start
• Radiation therapy within 2 weeks of study treatment start
• History of stem cell transplant (autologous or allogeneic) within 100 days prior to study enrollment
• Donor Lymphocyte Infusion (DLI) within 30 days prior to study entry
• Less than 30 days since last dose of antibody based therapies or less than 5 half-lives since last dose of previous therapy
• Requirement for systemic immune suppressive medication except as permitted in the protocol
• Current requirement for chronic blood product support