BP 42169 : An Open-Label, Multicenter, Phase 1 Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7293583, A TYRP1-Targeting CD3 T-Cell Engager, in Participants With Metastatic Melanoma

Male or<br/>FemaleGender Male or
Female

RecruitingStatus Recruiting

Systemic<br/>Therapy TrialTypeSystemic
Therapy Trial

OnePhase One

18+Age Over 18

Skin<br/>CancersCancer LocationSkin
Cancers

Systemic therapy | SkinMelanoma (Skin)

Trial Overview Read MoreRead more

This phase I trial is trying to understand the safety and appropriate dose level of a new immunotherapy treatment (RO7293583) in people with metastatic melanoma..
 

This trial is treating patients with unresectable, metastatic TYRP1-positive melanoma.

This is a systemic therapy trial.

You may be able to join this trial if:

  • You have been diagnosed with cancer, but have not received any treatment.
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • Your cancer has not spread to other parts of the body.
  • Your cancer has spread to other parts of the body.

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

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Scientific Title

An Open-Label, Multicenter, Phase 1 Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7293583, A TYRP1-Targeting CD3 T-Cell Engager, in Participants With Metastatic Melanoma

Commercial Sponsor

Hoffmann-La Roche

Summary

This is a non-randomised trial with two experimental parts. Part 1 focusses on dose escalation in single participant cohorts. Participants will receive RO7293583 (administered intravenously) every three weeks (Q3W). The starting dose will be 0.045mg and the maximum dose explored will be 1.5mg. Tocilizumab will be administered as required for the management of severe cytokine release syndrome (CRS). Part 2 focuses on multiple ascending dose-escalation of RO7293583 in multiple participant cohorts. The starting-dose for the initiation of the IV dose-escalation will be determined by Part I and RO7293583 will be administered intravenously or subcutaneously every three weeks. Dose-escalation will be undertaken based on safety until determination of the MTD or the highest safe dose if MTD is not reached. Fractionated, step up or subcutaneous dosing may be implemented. The maximum dose explored will be 600mg IV and 160mg SC.Tocilizumab will be administered as required for the management of severe cytokine release syndrome (CRS). Drug: Obinutuzumab If implemented, it will be given either on D-7 or D-7 and D-6. Drug: Adalimumab If implemented, it will be given as a single dose approximately 6 days prior to the first dose of RO7293583.

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.

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