A Study Evaluating the Safety, Pharmacokinetics, and Activity of Cevostamab in Participants With Relapsed or Refractory Multiple Myeloma

• Status: Recruiting
• Trial end date: 2023-12-05
• Target enrollment: 0
• Participant gender: All

Summary

This Phase Ib, multicenter, open-label study will evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of cevostamab which will be administered to participants with relapsed or refractory multiple myeloma (R/R MM) via intravenous (IV) infusion using a modified weekly schedule.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Genentech, Inc.
• Collaborator: Hoffmann-La Roche

Criteria

Inclusion Criteria:

• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1

• Life expectancy of at least 12 weeks

• Diagnosis of R/R MM for which no established therapy for MM is appropriate and available, or intolerance to those established therapies

• Agreement to provide bone marrow biopsy and aspirate samples

• Resolution of adverse events from prior anti-cancer therapy to Grade <=1

• Measurable disease

Exclusion Criteria:

• Prior treatment with cevostamab or another agent with the same target

• Pregnant or breastfeeding, or intending to become pregnant during the study or within 3 months after the last dose of study drug

• Prior use of any monoclonal antibody, radioimmunoconjugate, or antibody-drug conjugate as anti-cancer therapy within 4 weeks before first study treatment, except for the use of non-myeloma therapy

• Prior treatment with systemic immunotherapeutic agents, including, but not limited to, cytokine therapy and anti-CTLA4, anti-PD-1, and antiPD-L1 therapeutic antibodies within 12 weeks or 5 half-lives of the drug, whichever is shorter, before first study treatment

• Prior treatment with chimeric antigen receptor T (CAR T)-cell therapy within 12 weeks before first cevostamab infusion

• Prior allogeneic stem cell transplant(ation) (SCT)

• Known treatment-related, immune-mediated adverse events associated with prior checkpoint inhibitors

• Current or past history of central nervous system (CNS) disease, such as stroke, epilepsy, CNS vasculitis, neurodegenerative disease, or CNS involvement by MM

• Significant cardiovascular disease

• Symptomatic active pulmonary disease or requiring supplemental oxygen

• Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection

• Known or suspected chronic active Epstein-Barr virus (EBV) infection

• Recent major surgery within 4 weeks prior to first study treatment

• Positive serologic or PCR test results for acute or chronic hepatitis B virus (HBV) infection

• Acute or chronic hepatitis C virus (HCV) infection

• Known history of HIV seropositivity

• Administration of a live, attenuated vaccine within 4 weeks before first study treatment or anticipation that such a live attenuated vaccine will be required during the study

• Treatment with systemic immunosuppressive medications, with the exception of corticosteroid treatment <=10 mg/day prednisone or equivalent, within 2 weeks prior to first study treatment

• History of illicit drug or alcohol abuse within 12 months prior to screening, in the investigator's judgment