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NCT03075696 · ClinicalTrials.gov registry record · Phase 1
A Dose Escalation Study of Glofitamab (RO7082859) as a Single Agent and in Combination With Obinutuzumab, Administered After a Fixed, Single Pre-treatment Dose of Obinutuzumab in Participants With Relapsed/Refractory B-cell Non-hodgkin's Lymphoma
A Phase 1 study of Non-Hodgkin's Lymphoma, sponsored by Hoffmann-La Roche.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 940
- Enrollment target
- 20
- Study locations
NCT03075696 is a Phase 1 study of Non-Hodgkin's Lymphoma that is actively recruiting participants, run by Hoffmann-La Roche. The registered enrollment target is 940 participants, above the 207-participant average among 63 other Non-Hodgkin's Lymphoma trials with a reported enrollment target (354% higher). The trial reports 20 study locations across 11 states.
The verdict
NCT03075696, a Phase 1 study of Non-Hodgkin's Lymphoma, is actively recruiting participants, sponsored by Hoffmann-La Roche.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 940 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a Phase I/II, multicenter, open-label, dose-escalation study designed to evaluate the efficacy, safety, tolerability and pharmacokinetics (PK) of a novel T-Cell bispecific (TCB), glofitamab, administered by intravenous (IV) infusion as a single agent and in combination with obinutuzumab, following pre-treatment with a one-time, fixed dose of obinutuzumab. This entry-into-human (EIH) study is divided in 3 parts: dose escalation (Parts I and II) and dose expansion (Part III). Single-participant dose-escalation cohorts will be used in Part I, followed by conversion to multiple participant dose-escalation cohorts (Part II), in order to define a tentative maximum tolerated dose (MTD) or optimal biological dose (OBD). The expansion cohorts (Part III) will be initiated when the tentative MTD/OBD is defined, to further evaluate the safety, PK and therapeutic activity of glofitamab.
Conditions Studied
Interventions
- DRUG Obinutuzumab
- DRUG Glofitamab
- DRUG Tocilizumab
Study Locations (20)
Other
- Cliniques Universitaires St-Luc - Brussels
- UZ Gent - Ghent
- Vseobecna Fakultni Nemocnice v Praze, I. Interni Klinika - Klinika Hematoonkologie VFN a 1. LF UK - Prague
- Rigshospitalet - København Ø
- Helsinki University Central Hospital - Helsinki
- Hopital Henri Mondor - Créteil
- Hopital Claude Huriez - Lille
- CHU Saint Eloi - Montpellier
- Ch Lyon Sud - Pierre-Bénite
New York
- Mount Sinai Medical Center - New York
- MSKCC - New York
Illinois
- Ingalls Memorial Hospital - Harvey
Michigan
- University of Michigan - Ann Arbor
Missouri
- Washington University - St Louis
Pennsylvania
- Allegheny Health Network (Pittsburg PA) - Pittsburgh
Utah
- Hunstman Cancer Institute - Salt Lake City
Washington
- Swedish Cancer Inst. - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 940 participants |
| Start Date | 2017-02-21 |
| Est. Completion | 2029-12-31 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03075696
The ClinicalTrials.gov registry entry for NCT03075696 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 940 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 207-participant average among 63 other Non-Hodgkin's Lymphoma trials with a reported enrollment target (354% higher). The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Non-Hodgkin's Lymphoma appearing as the primary indexed condition, and to 3 interventions - of which Obinutuzumab is the first listed.
NCT03075696 reports 20 study locations spanning 11 distinct geographic areas - top geographies include Other, New York, Illinois.
Frequently Asked Questions
What is clinical trial NCT03075696 about?
NCT03075696 is a clinical study titled "A Dose Escalation Study of Glofitamab (RO7082859) as a Single Agent and in Combination With Obinutuzumab, Administered After a Fixed, Single Pre-treatment Dose of Obinutuzumab in Participants With Relapsed/Refractory B-cell Non-hodgkin's Lymphoma". This is a Phase I/II, multicenter, open-label, dose-escalation study designed to evaluate the efficacy, safety, tolerability and pharmacokinetics (PK) of a novel T-Cell bispecific (TCB), glofitamab, administered by intravenous (IV) infusion as a single agent and in combination with obinutuzumab, fol...
What is the current status of trial NCT03075696?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 940 participants. The study started on 2017-02-21. Estimated completion is 2029-12-31.
What conditions does trial NCT03075696 study?
This clinical trial studies the following conditions: Non-Hodgkin's Lymphoma.
What interventions are being tested in trial NCT03075696?
The interventions under investigation include: Obinutuzumab (DRUG), Glofitamab (DRUG), Tocilizumab (DRUG).
Who is sponsoring clinical trial NCT03075696?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03075696 being conducted?
This trial has 20 study locations across Illinois, Michigan, Missouri, New York, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.