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

Part of paid clinical trials in Denver, Colorado.

Sponsor
Genentech, Inc.
Study ID
NCT04045028
Phase
PHASE1
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Tiragolumab — DRUG
    Administered by IV infusion at a fixed dose of 600 mg on Day 1 of each 21-day cycle (Q3W)
  • Daratumumab/rHuPH20 — DRUG
    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
  • Rituximab — DRUG
    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).
  • Atezolizumab — DRUG
    Administered by IV infusion at a fixed dose of 1200 mg Q3W

Study Details

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).

Key Dates

Start date
Jul 22, 2019
Status verified
Apr 2023
Primary completion
Mar 28, 2023
Completion
Mar 28, 2023

Study Design

Enrollment
41 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A: Tiragolumab R/R MM
    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).
  • Experimental: Arm B: Tiragolumab R/R NHL
    Participants with relapsed or refractory (R/R) non-Hodgkin Lymphoma (NHL) will receive a single dose of 600 mg tiragolumab by IV infusion Q3W.
  • Experimental: Arm C: Tiragolumab + Daratumumab R/R MM
    Participants with R/R MM will receive 600 mg tiragolumab Q3W + daratumumab by subcutaneous (SC) injection.
  • Experimental: Arm D: Tiragolumab + Rituximab R/R NHL
    Participants with R/R NHL will receive 600 mg tiragolumab Q3W + rituximab by IV infusion and SC injection (optional).
  • Experimental: Arm E: Tiragolumab + Atezolizumab + Daratumumab R/R MM
    Participants with R/R MM will receive 600 mg tiragolumab Q3W + atezolizumab by IV infusion Q3W + daratumumab by SC injection.

Primary Outcome Measure

Percentage of Participants With Adverse Events [ Time Frame: Through study completion, an average of 1 year ]

Locations (9)

FacilityCityStateZIPSite coordinators
Colorado Blood Cancer Institute (CBCI) at Presbyterian/ St. Luke's Medical CenterDenverColorado80218-
Emory ClinicAtlantaGeorgia30322-
University of MarylandBaltimoreMaryland21201-
Washington UniversitySt LouisMissouri63128-
Clinical Research AllianceWestburyNew York11590-
Oncology Hematology Care, Inc.CincinnatiOhio45236-
University of Pennsylvania; School of MedicinePhiladelphiaPennsylvania19104-
SCRINashvilleTennessee37203-
Virginia Cancer Specialists (Fairfax) - USORFairfaxVirginia22031-

Find similar trials in Denver, CO

By condition
Multiple myeloma
By specialty
OncologyBlood cancer
By research site
Colorado Blood Cancer Institute (CBCI) at Presbyterian/ St. Luke's Medical Center· Denver, COEmory Clinic· Atlanta, GAUniversity of Maryland· Baltimore, MDWashington University· St Louis, MOClinical Research Alliance· Westbury, NYOncology Hematology Care, Inc.· Cincinnati, OH

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