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
18 Years and older, Male and Female
GO41036 (primary)
NCI-2019-06145
Summary
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).
Objectives
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
atezolizumab and/or daratumumab in participants with R/R MM or with rituximab in participants
with R/R NHL.
Eligibility
- 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
Treatment Sites in Georgia
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