Status:
TERMINATED
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
Lead Sponsor:
Genentech, Inc.
Conditions:
Multiple Myeloma
Non-Hodgkin Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 agen...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 22 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 28 2023
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT04045028
Start Date
July 22 2019
End Date
March 28 2023
Last Update
April 7 2023
Active Locations (14)
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1
Colorado Blood Cancer Institute (CBCI) at Presbyterian/ St. Luke's Medical Center
Denver, Colorado, United States, 80218
2
Emory Clinic
Atlanta, Georgia, United States, 30322
3
University of Maryland
Baltimore, Maryland, United States, 21201
4
Washington University
St Louis, Missouri, United States, 63128