A Study of RO7293583 in Participants With Unresectable Metastatic Tyrosinase Related Protein 1 (TYRP1)-Positive Melanomas

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Hoffmann-La Roche
Study ID
NCT04551352
Phase
PHASE1
Status
Completed

Conditions

  • Cutaneous Melanoma
  • Mucosal Melanoma
  • Uveal Melanoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • RO7293583 — DRUG
    RO7293583 will be administered at a dose and per schedule as specified for the respective cohort.
  • Tocilizumab — DRUG
    Tocilizumab will be administered as required for the management of severe cytokine release syndrome (CRS).
  • Obinutuzumab — DRUG
    If implemented, it will be given either on D-7 or D-7 and D-6.
  • Adalimumab — DRUG
    If implemented, it will be given as a single dose approximately 6 days prior to the first dose of RO7293583.

Study Details

This is a first-in-human, multi-center clinical study to determine the safety, Maximum Tolerated Dose (MTD) and/or Optimal Biological Dose (OBD) as well as the optimal schedule for intravenous (IV) and/or subcutaneous (SC) administrations of RO7293583 with or without obinutuzumab pretreatment, in participants with unresectable metastatic TYRP1-positive melanomas who have progressed on standard of care (SOC) treatment, are intolerant to SOC, or are non-amenable to SOC. This study will include an initial single participant dose-escalation part one followed by a multiple participant dose-escalation part two with the possibility of expansion.

Key Dates

Start date
Oct 28, 2020
Status verified
Sep 2022
Primary completion
Jul 28, 2022
Completion
Jul 28, 2022

Study Design

Enrollment
20 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Part I: Single Participant Cohorts (IV)
    Part I is a dose escalation in single participant cohorts. RO7293583 will be administered intravenously (IV) every three weeks (Q3W). The starting dose will be 0.045mg and the maximum dose explored will be 1.5mg.
  • Experimental: Part II: Multiple Participant Cohorts (IV/SC)
    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 IV or SC every 3 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.

Primary Outcome Measure

Percentage of Participants With Dose-Limiting Toxicities (DLTs) [ Time Frame: From Day 1 of Cycle 1 up to Day 1 of Cycle 3 (each cycle is 21 days) ]

Locations (4)

FacilityCityStateZIPSite coordinators
Dana Farber Cancer InstituteBostonMassachusetts02215-
Memorial Sloan-Kettering Cancer CenterNew YorkNew York10065-
Thomas Jefferson University Hospital;Medical OncologyPhiladelphiaPennsylvania19107-
Sarah Cannon Research InstituteNashvilleTennessee37203-

Find similar trials in Boston, MA

By research site
Dana Farber Cancer Institute· Boston, MAMemorial Sloan-Kettering Cancer Center· New York, NYThomas Jefferson University Hospital;Medical Oncology· Philadelphia, PASarah Cannon Research Institute· Nashville, TN

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