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

Overview

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).

SparkCures ID 1063
Trial Phase Phase 1
Enrollment 52 Patients
Treatments
Trial Sponsors
  • Genentech
NCT Identifier

NCT04045028

Am I Eligible?

The following criteria is a partial list of reasons why patients may or may not be eligible to participate in this clinical trial. Further evaluation with a medical professional will be required to determine full eligibility.

The following criteria is provided for health care professionals.

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

US Trial Locations

Accepting Patients

The following is a listing of trial locations that are open and accepting patients.

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Oncology Hematology Care Inc. (Kenwood)

Deer Park, OH

Colorado
Georgia
Verified Winship Cancer Institute of Emory University

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Missouri
Verified Alvin J. Siteman Cancer Center Washington University Medical Campus

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Ohio
Oncology Hematology Care Inc. (Kenwood)

Deer Park, OH

Pennsylvania
Tennessee
Virginia

Resources

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