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NCT02324257 · ClinicalTrials.gov registry record · Phase 1
A Study of RO6958688 in Participants With Locally Advanced and/or Metastatic Carcinoembryonic Antigen Positive Solid Tumors
A Phase 1 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 1
- Development phase
- 149
- Enrollment target
NCT02324257 is a Phase 1 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 149 participants.
The verdict
NCT02324257, a Phase 1 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 149 participants
- Enrollment target
Study Summary
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.
Interventions
- DRUG Obinutuzumab
- DRUG Tocilizumab
- DRUG RO6958688
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 149 participants |
| Start Date | 2014-12-30 |
| Est. Completion | 2019-09-03 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02324257
The ClinicalTrials.gov registry entry for NCT02324257 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 149 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Obinutuzumab is the first listed.
NCT02324257 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02324257 about?
NCT02324257 is a clinical study titled "A Study of RO6958688 in Participants With Locally Advanced and/or Metastatic Carcinoembryonic Antigen Positive Solid Tumors". 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 stan...
What is the current status of trial NCT02324257?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 149 participants. The study started on 2014-12-30. Estimated completion is 2019-09-03.
What interventions are being tested in trial NCT02324257?
The interventions under investigation include: Obinutuzumab (DRUG), Tocilizumab (DRUG), RO6958688 (DRUG).
Who is sponsoring clinical trial NCT02324257?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
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