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NCT03440437 · ClinicalTrials.gov registry record · Phase 1
A Phase 1/2 Study of FS118 in Patients With Advanced Malignancies
A Phase 1 study, sponsored by invoX Pharma Limited.
- Terminated
- Registry status
- Phase 1
- Development phase
- 80
- Enrollment target
NCT03440437: Clinical Trial Phase 1 study, sponsored by invoX Pharma Limited.
NCT03440437 is a Phase 1 study that was terminated before completion, run by invoX Pharma Limited. The registered enrollment target is 80 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03440437, a Phase 1 study, was terminated before completion, sponsored by invoX Pharma Limited.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 80 participants
- Enrollment target
Study Summary
This study will be conducted in adult participants diagnosed with advanced tumors to characterize the safety, tolerability, pharmacokinetics (PK), and activity of FS118. This is a Phase 1/2, multi-center, open-label, multiple-dose, first-in-human study, designed to systematically assess safety and tolerability, to identify the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) for FS118 in participants with advanced tumors and to determine the efficacy of FS118 in participants with squamous cell carcinoma of the head and neck (SCCHN) as monotherapy and in combination with paclitaxel. In addition to safety, pharmacokinetics, pharmacodynamics, immunogenicity and efficacy will also be assessed.
Primary Outcome
Incidence, severity and duration of adverse events will be assessed by CTCAEv4.03
Interventions
- DRUG Paclitaxel
- DRUG FS118
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2018-04-16 |
| Est. Completion | 2024-06-21 |
| Phase | Phase 1 |
Why NCT03440437 stopped before completion
NCT03440437 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% higher).
The record links to 0 conditions, and to 2 interventions - of which Paclitaxel is the first listed.
NCT03440437 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03440437 about?
NCT03440437 is a clinical study titled "A Phase 1/2 Study of FS118 in Patients With Advanced Malignancies". This study will be conducted in adult participants diagnosed with advanced tumors to characterize the safety, tolerability, pharmacokinetics (PK), and activity of FS118. This is a Phase 1/2, multi-center, open-label, multiple-dose, first-in-human study, designed to systematically assess safety and t...
What is the current status of trial NCT03440437?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 80 participants. The study started on 2018-04-16. Estimated completion is 2024-06-21.
What interventions are being tested in trial NCT03440437?
The interventions under investigation include: Paclitaxel (DRUG), FS118 (DRUG).
Who is sponsoring clinical trial NCT03440437?
This trial is sponsored by invoX Pharma Limited, which has 3 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03440437's enrollment target sits among peer trials
80 672nd of 2000 higher than 1,305 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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