Clinical trials are an important way to improve treatment for people with cancer. While most are continuing during the COVID-19 pandemic, the period of time that clinical trials are available and recruiting may change quickly. If you would like to get involved in a clinical trial, speak to your treatment team or the health service where the clinical trial is being undertaken, to confirm it is open and appropriate for you. For cancer information and support, call Cancer Council's experienced cancer nurses on 13 11 20 Monday to Friday from 9am-5pm.

NCT05219513 : An Open-Label, Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of RO7443904 in Combination With Glofitamab in Participants With Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma

Male or<br/>FemaleGender Male or
Female

RecruitingStatus Recruiting

Systemic<br/>Therapy TrialTypeSystemic
Therapy Trial

OnePhase One

18+Age Over 18

Blood<br/>CancersCancer LocationBlood
Cancers

Systemic therapy | Blood / Myeloma / LymphomaB-Cell Non Hodgkin Lymphoma,Lymphoma

Trial Overview Read MoreRead more

This phase I dose escalation study is seeking to determine the best dose level, safety and effectiveness of intravenous (IV) and/or subcutaneous (SC) dosing schemes of combination treatment (RO7443904, Glofitamab, Obinutuzumab and/or Tocilizumab) in people with relapsed or refractory B-cell non Hodgkin lymphoma.
 

This trial is treating patients with B-Cell Non-Hodgkin's Lymphoma.

This is a systemic therapy trial.

You may be able to join this trial if:

  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • You have had treatment, but your cancer has come back.

You may be excluded from this trial if:

  • You have a certain disease or psychological condition.
  • You have been diagnosed with a prior or secondary type of cancer.
  • You have had certain treatments, surgical procedures or drugs.

Clinical trials have complex eligibility criteria - talk to your doctor about your interest in this trial.

Clinical Summary Read MoreRead more

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Scientific Title

An Open-Label, Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of RO7443904 in Combination With Glofitamab in Participants With Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma

Commercial Sponsor

Hoffmann-La Roche

Summary

This study has two stages: dose escalation and dose expansion. The Dose Escalation stage (Parts I-III) consists of RO7443904 and glofitamab will take place every three weeks (Q3W) with obinutuzumab pre-treatment. RO7443904 will be administered by subcutaneous (SC) or IV infusion on Cycle 2, Day 8. From Cycle 3 onward, RO7443904 will be given every 3 weeks (Q3W) for up to 12 cycles. Glofitamab will be administered through IV infusion starting with step-up dosing (2.5mg/10mg/30mg) on C1D1, C1D8, and C2D1. Starting in Cycle 3, glofitamab will be given in 30mg doses Q3W. with RO7443904 for up to 12 cycles. Obinutuzumab will be administered once through IV infusion at a dose of 1g dose in Cycle 1, on either Day -7, -4, or -3. Tocilizumab will be administered as necessary to treat cytokine release syndrome. The Dose Expansion stage (Part IV) will evaluate selected dose levels of RO7443904 in combination with glofitamab from Parts 1-III in a Q3W regimen with obinutuzumab pre-treatment.

Recruiting Hospitals Read MoreRead more

PCCTU (Parkville Cancer Clinical Trials Unit) *
Parkville
Felicity McLeay
PCCTU.HaemB@petermac.org

Trial Overview: General information about a clinical trial. This section provides an overview of who might be able to join this trial and what type of treatment is involved.

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