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RecruitingLast updated:30 May 2023

NP30179: 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 drugA 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

Clinical summary

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**.

Age

People18+

Phase

I

Trial Acronym

NP30179

More information

Trial Identifiers

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Commercial Sponsor

Hoffmann-La Roche

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

Eligibility

Inclusion

  • You have certain types of non-cancer medical conditions.
  • You have been diagnosed with a prior or secondary type of cancer.
  • You have had certain treatments, surgical procedures or drugs.

Exclusion

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

Clinical trials have complex eligibility criteria.

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