A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of RO7443904 in Combination With Glofitamab in Participants With Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma

Part of paid clinical trials in New York, New York.

Sponsor
Hoffmann-La Roche
Study ID
NCT05219513
Phase
PHASE1
Status
Terminated

Conditions

  • Lymphoma, Non-Hodgkin

Eligibility Criteria

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

Interventions

  • RO7443904 — DRUG
    RO7443904 will be administered by subcutaneous (SC) or IV infusion on Cycle (C) 1 Day (D) 10, C2D3, and C2D8. From C3 onward, RO7443904 will be given every 3 weeks (Q3W), for up to 12 cycles (C = 21 days).
  • Glofitamab — DRUG
    Glofitamab will be administered through IV infusion starting with step-up dosing (2.5 mg/10 mg/30 mg) on C1D1, C1D8, and C2D1. Starting in Cycle 3, glofitamab will be given in 30 mg doses every three weeks (Q3W) with RO7443904, for up to 12 cycles (Cycle = 21 days).
  • Obinutuzumab — DRUG
    Obinutuzumab will be administered once through IV infusion, at a 1 g dose in Cycle 1, on either Day -7, -4, or -3 (C1D-7, C1D-4, C1D-3).
  • Tocilizumab — DRUG
    Tocilizumab will be administered as necessary to treat cytokine release syndrome (CRS).

Study Details

This is a first-in human, open-label, Phase 1 dose-escalation study in order to determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) for intravenous (IV) and/or subcutaneous (SC) dosing schemes of this combination treatment, and to evaluate the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of this combination treatment in participants with relapsed/refractory B-cell non Hodgkin lymphoma (r/r NHL).

Key Dates

First listed
Feb 2, 2022
Start date
Feb 18, 2022
Status verified
Aug 2024
Primary completion
Jul 17, 2024
Completion
Jul 17, 2024

Study Design

Enrollment
53 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Parts I-III: Dose-escalation of RO7443904
    The dose-escalation of RO7443904 and glofitamab will take place every three weeks (Q3W) with obinutuzumab pre-treatment.
  • Experimental: Part IV: Dose-expansion of RO7443904
    Part IV of this study will evaluate selected dose levels of RO7443904 in combination with glofitamab from Parts I-III in a Q3W regimen with obinutuzumab pre-treatment.

Primary Outcome Measure

Nature and frequency of dose-limiting toxicities (DLTs) [ Time Frame: From 3 weeks (21 days) from the first administration of RO7443904 (Cycle 2 Day 8) to 1 week after the second administration of RO7443904 (Cycle 3 Day 8) ]

Locations (3)

FacilityCityStateZIPSite coordinators
MSKCCNew YorkNew York10065-
Cleveland Clinic Foundation; Hematology and OncologyClevelandOhio44195-
University of PennsylvaniaPhiladelphiaPennsylvania19104-

Find similar trials in New York, NY

By research site
MSKCC· New York, NYCleveland Clinic Foundation; Hematology and Oncology· Cleveland, OHUniversity of Pennsylvania· Philadelphia, PA

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