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NCT01603979 · ClinicalTrials.gov registry record · Phase 1
A Phase 1 Dose Escalation Study of AV-203, an ERBB3 Inhibitory Antibody, in Subjects With Advanced Solid Tumors
A Phase 1 study, sponsored by AVEO Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
NCT01603979 is a Phase 1 study that has completed, run by AVEO Pharmaceuticals. The registered enrollment target is 24 participants.
The verdict
NCT01603979, a Phase 1 study, has completed, sponsored by AVEO Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
Study Summary
This is a Phase 1, multi-center, open-label, multiple dose, dose escalation study to evaluate the safety, tolerability, dose limiting toxicities (DLTs), maximum tolerated dose (MTD) and/or Recommended Phase 2 Dose (RP2D), pharmacokinetic (PK), pharmacodynamics, and preliminary anti-tumor activity of AV-203, an ERBB3 inhibitory antibody, administered once every 2 weeks via intravenous (IV) infusion in subjects with metastatic or advanced solid tumors. Once the RP2D is determined, patients with tumor types of interest will be evaluated in an expansion cohort at the RP2D for safety and anti-tumor activity.
Interventions
- BIOLOGICAL AV-203
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2012-05 |
| Est. Completion | 2014-12 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01603979
The ClinicalTrials.gov registry entry for NCT01603979 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AVEO Pharmaceuticals, which has 27 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which AV-203 is the first listed.
NCT01603979 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01603979 about?
NCT01603979 is a clinical study titled "A Phase 1 Dose Escalation Study of AV-203, an ERBB3 Inhibitory Antibody, in Subjects With Advanced Solid Tumors". This is a Phase 1, multi-center, open-label, multiple dose, dose escalation study to evaluate the safety, tolerability, dose limiting toxicities (DLTs), maximum tolerated dose (MTD) and/or Recommended Phase 2 Dose (RP2D), pharmacokinetic (PK), pharmacodynamics, and preliminary anti-tumor activity of...
What is the current status of trial NCT01603979?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2012-05. Estimated completion is 2014-12.
What interventions are being tested in trial NCT01603979?
The interventions under investigation include: AV-203 (BIOLOGICAL).
Who is sponsoring clinical trial NCT01603979?
This trial is sponsored by AVEO Pharmaceuticals, which has 27 total clinical trials registered on ClinicalTrials.gov.
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