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
- Multiple Myeloma
- South Korea
- United States
The source of the below information is the publicly available website ClinicalTrials.gov. It has been summarised and edited into simpler language.
The below information is taken directly from the publicly available website ClinicalTrials.gov within a week of any updates, and has not been edited.
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).
A Phase Ia/Ib Open-Label, Multicenter Study Evaluating the Safety and Pharmacokinetics of Tiragolumab as a Single Agent and in Combination With Atezolizumab and/or Daratumumab in Patients With Relapsed or Refractory Multiple Myeloma, and as a Single Agent and in Combination With Rituximab in Patients With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma
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.
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
For the latest version of this information please go to www.forpatients.roche.com