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NCT02650713 · ClinicalTrials.gov registry record · Phase 1
A Study of the Safety, Pharmacokinetics, and Therapeutic Activity of RO6958688 in Combination With Atezolizumab in Participants With Locally Advanced and/or Metastatic Carcinoembryonic Antigen (CEA)-Positive Solid Tumors
A Phase 1 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 1
- Development phase
- 228
- Enrollment target
NCT02650713 is a Phase 1 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 228 participants.
The verdict
NCT02650713, a Phase 1 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 228 participants
- Enrollment target
Study Summary
This is an open-label, multicenter, dose-escalation and expansion Phase Ib clinical study of RO6958688 in combination with atezolizumab. Part I of the study is subdivided into parts IA and IB. Part IA is dose escalation with a starting dose of 5 mg of RO6958688 given QW (once a week) and a fixed, flat dose of 1200 mg given Q3W (every 3 weeks) of atezolizumab, to evaluate the safety and determine the MTD of RO6958688 in combination with atezolizumab. Part IB is a dose/schedule finding part that will explore different administration schedules of RO6958688 in combination with atezolizumab (1200 mg Q3W) to establish the appropriate dose/schedule of RO6958688 in combination with atezolizumab.
Interventions
- DRUG Atezolizumab
- DRUG RO6958688
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 228 participants |
| Start Date | 2016-01-07 |
| Est. Completion | 2020-01-13 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02650713
The ClinicalTrials.gov registry entry for NCT02650713 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 228 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 2 interventions - of which Atezolizumab is the first listed.
NCT02650713 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02650713 about?
NCT02650713 is a clinical study titled "A Study of the Safety, Pharmacokinetics, and Therapeutic Activity of RO6958688 in Combination With Atezolizumab in Participants With Locally Advanced and/or Metastatic Carcinoembryonic Antigen (CEA)-Positive Solid Tumors". This is an open-label, multicenter, dose-escalation and expansion Phase Ib clinical study of RO6958688 in combination with atezolizumab. Part I of the study is subdivided into parts IA and IB. Part IA is dose escalation with a starting dose of 5 mg of RO6958688 given QW (once a week) and a fixed, fl...
What is the current status of trial NCT02650713?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 228 participants. The study started on 2016-01-07. Estimated completion is 2020-01-13.
What interventions are being tested in trial NCT02650713?
The interventions under investigation include: Atezolizumab (DRUG), RO6958688 (DRUG).
Who is sponsoring clinical trial NCT02650713?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
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