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).
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
41
Administered by IV infusion at a fixed dose of 600 mg on Day 1 of each 21-day cycle (Q3W)
Administered by SC injection 1800 mg/30,000 U rHuPH20 weekly for a total of 6 doses, then every 3 weeks for a total of 16 doses (first dose given at Week 7), then every 4 weeks from Week 55 onward until disease progression
Administered for a total of 8 doses. Rituximab will be administered by IV infusion for the first dose at a dose of 375 mg/m\^2. After administration of at least one full infusion of IV rituximab, the SC formulation of rituximab (rituximab and rHuPH20) may be used for the remaining doses per institutional guidelines. SC rituximab will be administered at a dose of 1400 mg rituximab/23400 U rHuPH20 once weekly (QW).
Administered by IV infusion at a fixed dose of 1200 mg Q3W
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
...and 4 more locations
Percentage of Participants With Adverse Events
Determined according to the NCI CTCAE Version 5.0
Time frame: Through study completion, an average of 1 year
Serum Concentration of Tiragolumab
Time frame: Cycles 1, 2, 3, 4, 8, 12, 16, 17 and then every 8 cycles (each cycle is 21 days) and at Treatment Discontinuation Visit (up to 2 years)
Serum Concentration of Atezolizumab
Time frame: Cycles 1, 2, 3, 4, 8, 12, 16, 17 and then every 8 cycles (each cycle is 21 days) and at Treatment Discontinuation Visit (up to 2 years)
Objective Response Rate (ORR) for R/R MM
Proportion of participants with a best overall response of stringent complete response (sCR), complete response (CR), very good partial response (VGPR) or partial response (PR), as defined by the International Myeloma Working Group (IMWG) criteria
Time frame: Through study completion, an average of 1 year
ORR for R/R NHL
Proportion of participants with a CR or PR on two consecutive occasions \>/= 4 weeks apart, according to the Lugano classification
Time frame: Through study completion, an average of 1 year
Percentage of Participants With Anti-Drug Antibodies (ADAs) to Tiragolumab
Time frame: Cycles 1, 2, 4, 8, 12, 16, 17 and then every 8 cycles (each cycle is 21 days) and at Treatment Discontinuation Visit (up to 2 years)
Percentage of Participants With ADAs to Atezolizumab
Time frame: Cycles 1, 2, 4, 8, 12, 16, 17 and then every 8 cycles (each cycle is 21 days) and at Treatment Discontinuation Visit (up to 2 years)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.