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.

NP30179 : A Multicenter, Open-Label, Phase I Study to Evaluate the Safety, Efficacy, Tolerability and Pharmacokinetics of Escalating Doses of Glofitamab (RO7082859) as a Single Agent and in Combination With Obinutuzumab Administered After a Fixed, Single Dose Pre-Treatment of Obinutuzumab (GazyvaÂ/Gazyvaroâ) in Patients 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 trial is trying to understand how safe and tolerable a new targeted cancer drug is for patients with B-Cell Non-Hodgkin's Lymphoma, and whether it is better given alone or in combination with another targeted cancer drug.
 

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 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

A Multicenter, Open-Label, Phase I Study to Evaluate the Safety, Efficacy, Tolerability and Pharmacokinetics of Escalating Doses of Glofitamab (RO7082859) as a Single Agent and in Combination With Obinutuzumab Administered After a Fixed, Single Dose Pre-Treatment of Obinutuzumab (GazyvaÂ/Gazyvaroâ) in Patients With Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma

Commercial Sponsor

Hoffmann-La Roche

Summary

This trial has three parts, to which eligible patients will be assigned: dose escalation (Parts 1 and 2) and dose expansion (Part 3). In Part 1, single participant cohorts will receive pre-treatment obinutuzumab, followed by a starting dose (Cycle 1) and then an ascending dose (from Cycle 2 onwards) of glofitamab for 12 Cycles or until the participant experiences unacceptable toxicity or disease progression. Part 2 will include multiple participant dose-escalation cohorts, in which patients will receive glofitamab as a single-agent, in combination with a fixed dose of obinutuzumab or as an initial low dose, followed by a higher dose on Cycle 1 Day 8 (step-up dosing). Part 3 (dose expansion) will commence once a maximum tolerated dose has been identified. In this part, patients will receive pre-treatment with obinituzumab, followed by glofitamab at a fixed dose regimen or step-up dose regimen as determined by Part 2 of the study and administered over 12 cycles. **PCCTU currently has limited spots available, please contact the study team regarding availability**.

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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