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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

Status
Active
Cancer Type
Multiple Myeloma
Trial Phase
Phase I
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCT ID
NCT04045028
Protocol IDs
GO41036 (primary)
NCI-2019-06145
Study Sponsor
Genentech Inc.

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

  1. 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

Emory Clinic


1365 Clifton Road NE
Atlanta, GA 30322
www.emoryhealthcare.org

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.
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