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NCT03549338 · ClinicalTrials.gov registry record · Phase 2
Sym004 Versus Futuximab or Modotuximab in Patients With mCRC
A Phase 2 study, sponsored by Symphogen A/S.
- Terminated
- Registry status
- Phase 2
- Development phase
- 2
- Enrollment target
NCT03549338: Clinical Trial Phase 2 study, sponsored by Symphogen A/S.
NCT03549338 is a Phase 2 study that was terminated before completion, run by Symphogen A/S. The registered enrollment target is 2 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03549338, a Phase 2 study, was terminated before completion, sponsored by Symphogen A/S.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 2 participants
- Enrollment target
Study Summary
This is a Phase 2, randomized, open-label, 3-arm trial in the ratio of 1:1:1 to either Sym004 (Arm A) versus each of its component monoclonal antibodies (mAbs), futuximab (Arm B) or modotuximab (Arm C), in genomically-selected patients with chemotherapy-refractory metastatic colorectal carcinoma (mCRC) and acquired resistance to anti-epidermal growth factor receptor (anti-EGFR) mAb therapy. The study is designed to evaluate the relative antitumor activity of each agent as assessed by imaging studies performed after 8 weeks of treatment.
Primary Outcome
Measured From Baseline to End of Trial Participation, as Assessed by the Common Terminology Criteria for AEs (Version 5) (CTCAE v5). AEs will be coded according to the Medical Dictionary for Regulatory Activities (MedDRA) terminology and the severity of the toxicities will be graded according to the CTCAE v5, where applicable.
Interventions
- DRUG Sym004
- DRUG Futuximab
- DRUG Modotuximab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2018-11-29 |
| Est. Completion | 2019-03-09 |
| Phase | Phase 2 |
Why NCT03549338 stopped before completion
NCT03549338 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 2 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 3 interventions - of which Sym004 is the first listed.
NCT03549338 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03549338 about?
NCT03549338 is a clinical study titled "Sym004 Versus Futuximab or Modotuximab in Patients With mCRC". This is a Phase 2, randomized, open-label, 3-arm trial in the ratio of 1:1:1 to either Sym004 (Arm A) versus each of its component monoclonal antibodies (mAbs), futuximab (Arm B) or modotuximab (Arm C), in genomically-selected patients with chemotherapy-refractory metastatic colorectal carcinoma (mC...
What is the current status of trial NCT03549338?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 2 participants. The study started on 2018-11-29. Estimated completion is 2019-03-09.
What interventions are being tested in trial NCT03549338?
The interventions under investigation include: Sym004 (DRUG), Futuximab (DRUG), Modotuximab (DRUG).
Who is sponsoring clinical trial NCT03549338?
This trial is sponsored by Symphogen A/S, which has 12 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03549338's enrollment target sits among peer trials
2 2001st of 2000 the lowest of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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