NCT04551352 : 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

Advanced CancersCancer LocationMulti-Cancer
Trial

Systemic therapy,Treatment | Head and neck,SkinMelanoma (Ocular)

Trial Overview Read MoreRead more

This phase I trial will assess how safe and well tolerated a new cancer drug is on its' own or following pre-treatment in patients with TYRP1-positive melanomas who have progressed on (or are not eligible for) standard of care.
 

This trial is treating patients with melanoma.

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

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 trial contains two dose escalation cohorts: single participant and multiple participant. In Part I (single participant cohorts), RO7293583 will be administered intravenously (IV) every three weeks (Q3W) at a starting dose of 0.045mg. The maximum dose explored in this part of the trial will be 1.5mg. In Part II (multiple participant cohorts), RO7293583 will be administered IV or SC every 3 weeks at a starting dose determined by Part I of the trial. Dose-escalation will be undertaken based on safety until determination of the maximum tolerated dose is reached. Fractionated, step up or subcutaneous (SC) dosing may be implemented. The maximum dose explored in Part II of the trial will be 600mg IV and 160mg SC.

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