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NCT04196283 · ClinicalTrials.gov registry record · Phase 1
A Study to Determine the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of ABBV-368 Plus Tilsotolimod and Other Therapy Combinations in Participants With Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma
A Phase 1 study of Advanced Solid Tumors Cancer, sponsored by AbbVie.
- Completed
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
- 20
- Study locations
NCT04196283: Completed Phase 1 study of Advanced Solid Tumors Cancer, sponsored by AbbVie.
NCT04196283 is a Phase 1 study of Advanced Solid Tumors Cancer that has completed, run by AbbVie. The registered enrollment target is 30 participants, below the 351-participant average among 9 other Advanced Solid Tumors Cancer trials with a reported enrollment target (91% lower). The trial reports 20 study locations across 18 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04196283, a Phase 1 study of Advanced Solid Tumors Cancer, has completed, sponsored by AbbVie.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
- 20
- Study locations
Study Summary
The main objective of this study is to assess safety, tolerability, and pharmacokinetics (PK) of ABBV-368 plus tilsotolimod; ABBV-368 plus tilsotolimod and nab-paclitaxel; and ABBV-368 plus tilsotolimod, nab-paclitaxel, and ABBV-181 in participants with recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC).
Primary Outcome
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study.
Conditions Studied
Interventions
- DRUG Nab-paclitaxel
- DRUG ABBV-181
- DRUG ABBV-368
- DRUG Tilsotolimod
Study Locations (20)
Other
- Charite Universitaetsklinikum Berlin - Campus Benjamin Franklin /ID# 214197 - Berlin
- Rambam Health Care Campus /ID# 215231 - Haifa
- Gastroenterology Institute, Division of Medicine /ID# 215862 - Jerusalem
Illinois
- The University of Chicago Medical Center /ID# 217196 - Chicago
Kentucky
- Norton Cancer Institute /ID# 216179 - Louisville
Michigan
- Barbara Ann Karmanos Cancer In /ID# 214050 - Detroit
Nebraska
- Nebraska Methodist Hospital /ID# 215786 - Omaha
New Jersey
- Atlantic Health System /ID# 216159 - Morristown
New York
- Roswell Park Comprehensive Cancer Center /ID# 215882 - Buffalo
Tennessee
- Vanderbilt Ingram Cancer Center /ID# 214040 - Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2020-01-22 |
| Est. Completion | 2022-10-27 |
| Phase | Phase 1 |
What the finished NCT04196283 record still lists
NCT04196283 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 351-participant average among 9 other Advanced Solid Tumors Cancer trials with a reported enrollment target (91% lower).
The record links to 1 condition, with Advanced Solid Tumors Cancer appearing as the primary indexed condition, and to 4 interventions - of which Nab-paclitaxel is the first listed.
NCT04196283 names 20 study sites across 18 states, led by Other, Illinois, Kentucky.
Frequently Asked Questions
What is clinical trial NCT04196283 about?
NCT04196283 is a clinical study titled "A Study to Determine the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of ABBV-368 Plus Tilsotolimod and Other Therapy Combinations in Participants With Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma". The main objective of this study is to assess safety, tolerability, and pharmacokinetics (PK) of ABBV-368 plus tilsotolimod; ABBV-368 plus tilsotolimod and nab-paclitaxel; and ABBV-368 plus tilsotolimod, nab-paclitaxel, and ABBV-181 in participants with recurrent/metastatic (R/M) head and neck squam...
What is the current status of trial NCT04196283?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2020-01-22. Estimated completion is 2022-10-27.
What conditions does trial NCT04196283 study?
This clinical trial studies the following conditions: Advanced Solid Tumors Cancer.
What interventions are being tested in trial NCT04196283?
The interventions under investigation include: Nab-paclitaxel (DRUG), ABBV-181 (DRUG), ABBV-368 (DRUG), Tilsotolimod (DRUG).
Who is sponsoring clinical trial NCT04196283?
This trial is sponsored by AbbVie, which has 526 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04196283 being conducted?
This trial has 20 study locations across Illinois, Kentucky, Michigan, Nebraska, New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04196283's enrollment target sits among peer trials
30 10th of 9 the lowest of 9 other Advanced Solid Tumors Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Advanced Solid Tumors 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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