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A Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), Pharmacodynamics (PD), and Preliminary Activity of Tiragolumab in Participants With Relapsed or Refractory Multiple Myeloma or With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma

Trial Status: Active

This is a Phase I open-label, multicenter study designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary activity of tiragolumab administered as a single agent or in combination with daratumumab or rituximab in participants with relapsed or refractory (R / R) multiple myeloma (MM) or R / R non-Hodgkin lymphoma (NHL).

Inclusion Criteria

  • Inclusion Criteria: General Inclusion Criteria (All Participants): - Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 - Life expectancy of >/= 12 weeks Inclusion Criteria Specific to Arms A and C (R/R MM) - Arm A only: Must have R/R MM for which no established therapy for MM is appropriate and available or be intolerant to those established therapies - Arm C only: Participants with R/R MM who have received at least 3 prior lines of therapy. - Measurable disease defined by laboratory test results. Inclusion Criteria Specific to Arms B and D (R/R NHL) - Participants with histologically confirmed B-cell NHL who have relapsed or failed to respond to at least two prior systemic treatment regimens and for which no suitable therapy of curative intent or higher priority exists. - Must have at least one bi-dimensionally measurable lesion. Exclusion Criteria: General Exclusion Criteria (All Participants) - Any anti-cancer therapy, whether investigational or approved, including chemotherapy, monoclonal antibody, radioimmunoconjugate, antibody-drug conjugate, hormonal therapy, and/or radiotherapy, within 4 weeks or 5 half-lives of the drug, whichever is shorter, prior to initiation of study treatment - Prior treatment with any anti-TIGIT agent - Prior treatment with chimeric antigen receptor-T (CAR-T) therapy within 30 days before first study drug administration - Autologous Stem-Cell Transplantation (ASCT) within 100 days prior to first study drug administration - Active or history of autoimmune disease or immune deficiency - Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection at study enrollment, or any major episode of infection within 4 weeks prior to first study drug administration Exclusion Criteria Specific to Arms A and C (R/R MM) - Primary or secondary plasma cell leukemia - Current or history of CNS involvement by MM Exclusion Criteria Specific to Arms B and D (R/R NHL) - Uncontrolled hypercalcemia or symptomatic hypercalcemia requiring continued use of bisphosphonate therapy or denosumab - Current or history of CNS lymphoma - Current eligibility for ASCT Other protocol defined inclusion/exclusion criteria could apply

Georgia

Atlanta
Emory University Hospital / Winship Cancer Institute
Status: ACTIVE
Emory University Hospital Midtown
Status: ACTIVE

Missouri

Saint Louis
Siteman Cancer Center at Washington University
Status: ACTIVE

Pennsylvania

Philadelphia
University of Pennsylvania / Abramson Cancer Center
Status: ACTIVE

In the Phase Ia part of the study, tiragolumab is administered as a single agent in participants with R/R MM or R/R NHL. In the Phase Ib part of the study, tiragolumab is administered in combination with daratumumab in participants with R/R MM or with rituximab in participants with R/R NHL for whom combination therapy is considered an acceptable treatment option.

Trial Phase Phase I

Trial Type Treatment

Lead Organization
Genentech Inc.

  • Primary ID GO41036
  • Secondary IDs NCI-2019-06145
  • Clinicaltrials.gov ID NCT04045028