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NCT02558140 · ClinicalTrials.gov registry record · Phase 1
A Dose Escalation Study of RO6874813 in Participants With Locally Advanced or Metastatic Solid Tumors
A Phase 1 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 1
- Development phase
- 120
- Enrollment target
NCT02558140 is a Phase 1 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 120 participants.
The verdict
NCT02558140, a Phase 1 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 120 participants
- Enrollment target
Study Summary
This first-in-human study consists of three parts. The primary purpose of Part 1 is to characterize the safety and tolerability of RO6874813 in participants with locally advanced and/or metastatic solid tumors whose disease has progressed despite standard therapy or for whom no standard therapy exists. In addition, the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) will be determined. In Part 2 the safety and tolerability of RO6874813 will continue to be characterized in participants with locally advanced and/or metastatic solid tumors known to be fibroblast activation protein-alpha positive (FAP+). In addition, treatment-induced efficacy of RO6874813 will be assessed by functional imaging and paired tumor biopsies. The primary purpose of Part 3 is to demonstrate anti-tumor activity of RO6874813 in participants with recurrent or metastatic FAP+ sarcomas.
Interventions
- BIOLOGICAL RO6874813
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2015-10-11 |
| Est. Completion | 2017-11-06 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02558140
The ClinicalTrials.gov registry entry for NCT02558140 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 120 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 1 intervention - of which RO6874813 is the first listed.
NCT02558140 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02558140 about?
NCT02558140 is a clinical study titled "A Dose Escalation Study of RO6874813 in Participants With Locally Advanced or Metastatic Solid Tumors". This first-in-human study consists of three parts. The primary purpose of Part 1 is to characterize the safety and tolerability of RO6874813 in participants with locally advanced and/or metastatic solid tumors whose disease has progressed despite standard therapy or for whom no standard therapy exis...
What is the current status of trial NCT02558140?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 120 participants. The study started on 2015-10-11. Estimated completion is 2017-11-06.
What interventions are being tested in trial NCT02558140?
The interventions under investigation include: RO6874813 (BIOLOGICAL).
Who is sponsoring clinical trial NCT02558140?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
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