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NCT03035253 · ClinicalTrials.gov registry record · Phase 1
A Study of OMP-305B83 in Subjects With Metastatic Colorectal Cancer
A Phase 1 study, sponsored by OncoMed Pharmaceuticals.
- Terminated
- Registry status
- Phase 1
- Development phase
- 16
- Enrollment target
NCT03035253: Clinical Trial Phase 1 study, sponsored by OncoMed Pharmaceuticals.
NCT03035253 is a Phase 1 study that was terminated before completion, run by OncoMed Pharmaceuticals. The registered enrollment target is 16 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03035253, a Phase 1 study, was terminated before completion, sponsored by OncoMed Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 16 participants
- Enrollment target
Study Summary
The purpose of this study is to test the safety and efficacy of an experimental drug, OMP-305B83, when given in combination with FOLFIRI or FOLFOX. OMP-305B83 is a humanized bispecific monoclonal antibody and was developed to target cancer stem cells. Based on preclinical studies, it is believed that OMP-305B83 may block the growth of cancer stem cells and may also impair the productive growth of new blood vessels, which tumors need to grow and spread. The study is sponsored by OncoMed Pharmaceuticals, which is referred to as OncoMed or the Sponsor.
Primary Outcome
The maximum tolerated dose (MTD) or maximum administered dose (MAD) will be determined in patients treated with OMP-305B83 in combination with FOLFIRI or FOLFOX
Interventions
- DRUG FOLFIRI
- DRUG FOLFOX
- DRUG OMP-305B83
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2016-12 |
| Est. Completion | 2018-12 |
| Phase | Phase 1 |
Why NCT03035253 stopped before completion
NCT03035253 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% lower).
The record links to 0 conditions, and to 3 interventions - of which FOLFIRI is the first listed.
NCT03035253 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03035253 about?
NCT03035253 is a clinical study titled "A Study of OMP-305B83 in Subjects With Metastatic Colorectal Cancer". The purpose of this study is to test the safety and efficacy of an experimental drug, OMP-305B83, when given in combination with FOLFIRI or FOLFOX. OMP-305B83 is a humanized bispecific monoclonal antibody and was developed to target cancer stem cells. Based on preclinical studies, it is believed tha...
What is the current status of trial NCT03035253?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2016-12. Estimated completion is 2018-12.
What interventions are being tested in trial NCT03035253?
The interventions under investigation include: FOLFIRI (DRUG), FOLFOX (DRUG), OMP-305B83 (DRUG).
Who is sponsoring clinical trial NCT03035253?
This trial is sponsored by OncoMed Pharmaceuticals, which has 25 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03035253's enrollment target sits among peer trials
16 1786th of 2000 higher than 203 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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