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

Stopped early · Phase 1

Conditions studied: Multiple Myeloma, Non-Hodgkin Lymphoma, B-Cell Lymphoma

In brief

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).

Key facts

Study ID

NCT04045028

Run by

Genentech, Inc.

People needed

41

Starts

2019-07-22

Expected to finish

2023-03-28

Last updated by the study team

2023-04-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Colorado Blood Cancer Institute (CBCI) at Presbyterian/ St. Luke's Medical Center — Denver, Colorado, United States
• Emory Clinic — Atlanta, Georgia, United States
• University of Maryland — Baltimore, Maryland, United States
• Washington University — St Louis, Missouri, United States
• Clinical Research Alliance — Westbury, New York, United States
• Oncology Hematology Care, Inc. — Cincinnati, Ohio, United States
• University of Pennsylvania; School of Medicine — Philadelphia, Pennsylvania, United States
• SCRI — Nashville, Tennessee, United States
• Virginia Cancer Specialists (Fairfax) - USOR — Fairfax, Virginia, United States
• Samsung Medical Center; Nephrology Department — Seoul, South Korea
• Seoul National University Hospital — Seoul, South Korea
• Yonsei Cancer Center; Yonsei Uni Coll. Med. — Seoul, South Korea
• Seoul St.Mary's Hospital; Medical Oncology — Seoul, South Korea
• Asan Medical Center; Internal Dept / Gastorenterology — Seoul, South Korea

Full record on ClinicalTrials.gov

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