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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 is a Phase 1 study that was terminated before completion, run by invoX Pharma Limited. The registered enrollment target is 80 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03440437
The ClinicalTrials.gov registry entry for NCT03440437 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 80 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is invoX Pharma Limited, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Paclitaxel is the first listed.
NCT03440437 reports 0 study locations.
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.
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