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 (Gazyva®/Gazyvaro™) 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 (Gazyva®/Gazyvaro™) 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.

Recruiting Hospitals Read MoreRead more

PCCTU (Parkville Cancer Clinical Trials Unit) *
Parkville
Enquiries Line Coordinator
clinicaltrials.enquiries@petermac.org
03 8559 7456 (9am-2pm, Mon-Fri)

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.

Next