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

What's the purpose of this trial?

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 atezolizumab and/or daratumumab or rituximab in participants with relapsed or refractory (R/R) multiple myeloma (MM) or R/R non-Hodgkin lymphoma (NHL).

This trial is currently open and accepting patients.

What will happen during the trial?

You may be able to join this trial if you:

The following criteria is a partial list of reasons why patients may be eligible to participate in this clinical trial. Further evaluation with a medical professional is required.

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, C and E (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
    • Arms C and E 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 12 weeks 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 (including SARS-CoV-2), 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, C and E (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

Additional Trial Information

Phase 1

Enrollment: 60 patients (estimated)

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Trial Locations

All Trial Locations

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Colorado

Colorado Blood Cancer Institute Sarah Cannon at Presbyterian/St. Luke's Medical Center (HealthONE)

Denver, CO

Open and Accepting

Georgia

Winship Cancer Institute of Emory University

Atlanta, GA

Open and Accepting

Maryland

University of Maryland Medical Center Marlene and Stewart Greenebaum Comprehensive Cancer Center

Baltimore, MD

Open and Accepting

Ohio

Oncology Hematology Care Inc. (Kenwood)

Cincinnati, OH

Open and Accepting

Pennsylvania

Abramson Cancer Center University of Pennsylvania

Philadelphia, PA

Open and Accepting

Tennessee

Sarah Cannon TriStar Centennial Medical Center

Nashville, TN

Open and Accepting

Virginia

Virginia Cancer Specialists

Fairfax, VA

Open and Accepting
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