A Study of RO6958688 in Participants With Locally Advanced and/or Metastatic Carcinoembryonic Antigen Positive Solid Tumors

Part of paid clinical trials in Los Angeles, California.

Sponsor
Hoffmann-La Roche
Study ID
NCT02324257
Phase
PHASE1
Status
Completed

Conditions

  • Solid Tumors

Eligibility Criteria

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

Interventions

  • RO6958688 — DRUG
    RO6958688 is given as an intravenous (IV) infusion as a single administration in Part I, and QW, Q3W, or as a combined QW/Q3W step up dosing regimen (cycle = 7 days in the QW regimen and cycle = 21 days in the Q3W regimen) in Part II of the study.
  • Obinutuzumab — DRUG
    Obinutuzumab is given as an IV infusion at a dose level of 2000 mg on Day -13 or 1000 mg on Days -13 and -12 prior to the treatment start with RO6958688 on Cycle 1 Day 1.
  • Tocilizumab — DRUG
    Tocilizumab will be administered as an IV infusion as necessary to treat adverse events.

Study Details

Study BP29541 is a first-in-human, open-label, multi-center, dose-escalation Phase I clinical study of single-agent RO6958688 in participants with locally advanced and/or metastatic carcinoembryonic antigen (CEA) positive solid tumors who have progressed on standard treatment, are intolerant to standard of care (SOC), and/or are non-amenable to SOC. The study will be conducted in two parts. Part I of the study will investigate the safety and pharmacokinetics of a single dose of RO6958688 in single participant cohorts with dosing starting from a minimal anticipated biological effect level dose of 0.05 milligrams (mg) and up to a maximum dose of 2.5 mg. Part II will establish the appropriate therapeutic dose based on safety, pharmacokinetics, and the maximum tolerated dose (MTD) of RO6958688 for the once per week (QW) regimen, every three weeks (Q3W) regimen, and for the step up dosing regimen.

Key Dates

Start date
Dec 30, 2014
Status verified
Apr 2020
Primary completion
Sep 3, 2019
Completion
Sep 3, 2019

Study Design

Enrollment
149 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Part I: RO6958688
    Participants will receive single dose of RO6958688 starting from a dose of 0.05, 0.15, 0.45, 1.3, and 2.5 mg in Part I of the study.
  • Experimental: Part II: RO6958688 With/Without Obinutuzumab Pretreatment
    Participants will receive RO6958688 with or without obinutuzumab pretreatment QW, Q3W, or according to a combined QW/Q3W step up dosing schedule. Doses will start at 40mg and increase with each administration up to the MTD or 1200mg, whichever is lower.

Primary Outcome Measure

Percentage of Participants with Adverse Events (AEs) or Serious Adverse Events (SAEs) [ Time Frame: Baseline up to 60 months ]

Locations (9)

FacilityCityStateZIPSite coordinators
Cedars Sinai Medical Center; Samuel-Oschin Comprehensive Cancer InstituteLos AngelesCalifornia90048-
Stanford UniversityPalo AltoCalifornia94305-
UCLA Cancer CenterSanta MonicaCalifornia90404-
University Of ColoradoAuroraColorado80045-
Yale Cancer Center; Medical OncologyNew HavenConnecticut06520-
Dana Farber - HarvardBostonMassachusetts--
Columbia University Medical CenterNew YorkNew York10032-
Medical University of South CarolinaCharlestonSouth Carolina29425-
Sarah Cannon Cancer CenterGermantownTennessee38138-

Find similar trials in Los Angeles, CA

By research site
Cedars Sinai Medical Center; Samuel-Oschin Comprehensive Cancer Institute· Los Angeles, CAStanford University· Palo Alto, CAUCLA Cancer Center· Santa Monica, CAUniversity Of Colorado· Aurora, COYale Cancer Center; Medical Oncology· New Haven, CTDana Farber - Harvard· Boston, MA

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