Description:
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 daratumumab or rituximab in
participants with relapsed or refractory (R/R) multiple myeloma (MM) or R/R non-Hodgkin
lymphoma (NHL).
Title
- Brief Title: 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
- Official Title: A Phase Ia/Ib Open-Label, Multicenter Study Evaluating The Safety and Pharmacokinetics of Tiragolumab as a Single Agent and In Combination With 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
Clinical Trial IDs
- ORG STUDY ID:
GO41036
- NCT ID:
NCT04045028
Conditions
- Multiple Myeloma
- Non-Hodgkin Lymphoma
- B-Cell Lymphoma
Interventions
Drug | Synonyms | Arms |
---|
Tiragolumab | | Arm A (Phase Ia) |
Daratumumab/rHuPH20 | | Arm C (Phase Ib) |
Rituximab | | Arm D (Phase Ib) |
Purpose
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 daratumumab or rituximab in
participants with relapsed or refractory (R/R) multiple myeloma (MM) or R/R non-Hodgkin
lymphoma (NHL).
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 with
daratumumab in participants with R/R MM or with rituximab in participants with R/R NHL for
whom combination therapy is considered an acceptable treatment option.
Trial Arms
Name | Type | Description | Interventions |
---|
Arm A (Phase Ia) | Experimental | Participants with relapsed or refractory (R/R) Multiple Myeloma (MM) will receive a single dose of 600 mg Tiragolumab by intravenous (IV) infusion on Day 1 of each 21-day cycle (Q3W). | |
Arm B (Phase Ia) | Experimental | Participants with relapsed or refractory (R/R) non-Hodgkin Lymphoma (NHL) will receive a single dose of 600 mg Tiragolumab by IV infusion Q3W. | |
Arm C (Phase Ib) | Experimental | Participants with R/R MM will receive 600 mg Tiragolumab Q3W + Daratumumab by subcutaneous (SC) injection. | - Tiragolumab
- Daratumumab/rHuPH20
|
Arm D (Phase Ib) | Experimental | Participants with R/R NHL will receive 600 mg Tiragolumab Q3W + Rituximab by IV infusion and SC injection (optional). | |
Eligibility Criteria
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 and C (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
- Arm C 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 30 days 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, 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 and C (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
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Percentage of Participants With Adverse Events |
Time Frame: | Through study completion, an average of 1 year |
Safety Issue: | |
Description: | Determined according to the NCI CTCAE Version 5.0 |
Secondary Outcome Measures
Measure: | Serum Concentration of Tiragolumab |
Time Frame: | Cycles 1, 2, 3, 4, 8, 16, 17 and then every 8 cycles (each cycle is 21 days) and at Treatment Discontinuation Visit (up to 2 years) |
Safety Issue: | |
Description: | |
Measure: | Objective Response Rate (ORR) for R/R MM |
Time Frame: | Through study completion, an average of 1 year |
Safety Issue: | |
Description: | 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 |
Measure: | ORR for R/R NHL |
Time Frame: | Through study completion, an average of 1 year |
Safety Issue: | |
Description: | Proportion of participants with a CR or PR on two consecutive occasions >/= 4 weeks apart, according to the Lugano classification |
Measure: | Percentage of Participants With Anti-Drug Antibodies (ADA) to Tiragolumab |
Time Frame: | Cycles 1, 2, 4, 8, 16, 17 and then every 8 cycles (each cycle is 21 days) and at Treatment Discontinuation Visit (up to 2 years) |
Safety Issue: | |
Description: | |
Details
Phase: | Phase 1 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Genentech, Inc. |
Last Updated
August 17, 2021