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NCT05223673 · ClinicalTrials.gov registry record · Phase 3
Phase 3 Study of Futuximab/Modotuximab in Combination With Trifluridine/Tipiracil Versus Trifluridine/Tipiracil Single Agent in Participants With Previously Treated Metastatic Colorectal Cancer
A Phase 3 study, sponsored by Institut de Recherches Internationales Servier.
- Terminated
- Registry status
- Phase 3
- Development phase
- 7
- Enrollment target
NCT05223673: Clinical Trial Phase 3 study, sponsored by Institut de Recherches Internationales Servier.
NCT05223673 is a Phase 3 study that was terminated before completion, run by Institut de Recherches Internationales Servier. The registered enrollment target is 7 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05223673, a Phase 3 study, was terminated before completion, sponsored by Institut de Recherches Internationales Servier.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 7 participants
- Enrollment target
Study Summary
This is a randomized phase III study with a safety lead-in part in patients with KRAS/ NRAS and BRAF Wild Type metastatic colorectal cancer who have previously received treatment with oxaliplatin, irinotecan, fluoropyrimidines, anti-VEGF agents and anti-EGFR antibodies. The main objective of the safety lead-in part is to assess safety and tolerability of futuximab/modotuximab in combination with trifluridine/tipiracil. The primary objective of the phase III part is to compare Overall Survival of futuximab/modotuximab in combination with trifluridine/tipiracil vs trifluridine/tipiracil monotherapy in patients with tumours that are KRAS/NRAS and BRAF wild-type (WT).
Primary Outcome
DLTs observed during a 28-day period. A DLT is defined as the following: A clinically significant AE graded according to the NCI-CTCAE version 5.0, observed during the initial 28- day treatment period following the first IMP administration. Assessed as unrelated to underlying disease, disease progression, intercurrent illness, or concomitant medications. At least possibly related to the IMPs (futuximab/modotuximab or trifluridine/tipiracil or both) by the investigator and meeting criteria as out
Interventions
- DRUG Trifluridine/Tipiracil
- BIOLOGICAL Futuximab/modotuximab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2022-04-21 |
| Est. Completion | 2023-06-21 |
| Phase | Phase 3 |
Why NCT05223673 stopped before completion
NCT05223673 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 7 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 2 interventions - of which Trifluridine/Tipiracil is the first listed.
NCT05223673 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05223673 about?
NCT05223673 is a clinical study titled "Phase 3 Study of Futuximab/Modotuximab in Combination With Trifluridine/Tipiracil Versus Trifluridine/Tipiracil Single Agent in Participants With Previously Treated Metastatic Colorectal Cancer". This is a randomized phase III study with a safety lead-in part in patients with KRAS/ NRAS and BRAF Wild Type metastatic colorectal cancer who have previously received treatment with oxaliplatin, irinotecan, fluoropyrimidines, anti-VEGF agents and anti-EGFR antibodies. The main objective of the saf...
What is the current status of trial NCT05223673?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 7 participants. The study started on 2022-04-21. Estimated completion is 2023-06-21.
What interventions are being tested in trial NCT05223673?
The interventions under investigation include: Trifluridine/Tipiracil (DRUG), Futuximab/modotuximab (BIOLOGICAL).
Who is sponsoring clinical trial NCT05223673?
This trial is sponsored by Institut de Recherches Internationales Servier, which has 27 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05223673's enrollment target sits among peer trials
7 1995th of 2000 higher than 6 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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