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

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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