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NCT03518554 · ClinicalTrials.gov registry record · Phase 1
A First in Human, Dose Escalation Study of JAB-3068 （SHP2 Inhibitor） in Adult Patients With Advanced Solid Tumors
A Phase 1 study of Non-Small Cell Lung Cancer and Head and Neck Cancer, sponsored by Jacobio Pharmaceuticals Co..
- Completed
- Registry status
- Phase 1
- Development phase
- 38
- Enrollment target
- 4
- Study locations
NCT03518554: Completed Phase 1 study of Non-Small Cell Lung Cancer and Head and Neck Cancer, sponsored by Jacobio Pharmaceuticals Co..
NCT03518554 is a Phase 1 study of Non-Small Cell Lung Cancer and Head and Neck Cancer that has completed, run by Jacobio Pharmaceuticals Co.. The registered enrollment target is 38 participants, below the 652-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (94% lower). The trial reports 4 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03518554, a Phase 1 study of Non-Small Cell Lung Cancer and Head and Neck Cancer, has completed, sponsored by Jacobio Pharmaceuticals Co..
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 38 participants
- Enrollment target
- 4
- Study locations
Study Summary
This is a phase 1, multi-center, dose escalation, open-label study to evaluate the safety, tolerability, pharmacokinetics, and preliminary evidence of antitumor activity of JAB-3068 in adult patients with advanced solid.
Primary Outcome
Incidence of dose limiting toxicities (DLTs) in the dose escalation phase. A DLT is defined as an adverse event or abnormal laboratory value assessed as unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurs within the first treatment cycle with JAB-3068.
Conditions Studied
Interventions
- DRUG JAB-3068
Study Locations (4)
Colorado
- HealthONE Clinic Services Oncology-Hematology - Denver
Florida
- Florida Cancer Specialists - Sarasota
Tennessee
- Sarah Cannon Research Institute - Nashville
Texas
- The University of Texas M. D. Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2018-04-23 |
| Est. Completion | 2022-02-03 |
| Phase | Phase 1 |
What the finished NCT03518554 record still lists
NCT03518554 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 38 participants, a relatively small participant target, below the 652-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (94% lower).
The record links to 4 conditions, with Non-Small Cell Lung Cancer appearing as the primary indexed condition, and to 1 intervention - of which JAB-3068 is the first listed.
NCT03518554 reports a single indexed study location in Colorado, Florida, Tennessee.
Frequently Asked Questions
What is clinical trial NCT03518554 about?
NCT03518554 is a clinical study titled "A First in Human, Dose Escalation Study of JAB-3068 （SHP2 Inhibitor） in Adult Patients With Advanced Solid Tumors". This is a phase 1, multi-center, dose escalation, open-label study to evaluate the safety, tolerability, pharmacokinetics, and preliminary evidence of antitumor activity of JAB-3068 in adult patients with advanced solid.
What is the current status of trial NCT03518554?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 38 participants. The study started on 2018-04-23. Estimated completion is 2022-02-03.
What conditions does trial NCT03518554 study?
This clinical trial studies the following conditions: Non-Small Cell Lung Cancer, Head and Neck Cancer, Esophageal Cancer, Other Metastatic Solid Tumors.
What interventions are being tested in trial NCT03518554?
The interventions under investigation include: JAB-3068 (DRUG).
Who is sponsoring clinical trial NCT03518554?
This trial is sponsored by Jacobio Pharmaceuticals Co., which has 7 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03518554 being conducted?
This trial has 4 study locations across Colorado, Florida, Tennessee, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03518554's enrollment target sits among peer trials
38 373rd of 454 higher than 79 of 454 other Non-Small Cell Lung Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Non-Small Cell Lung Cancer 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.
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