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NCT03071757 · ClinicalTrials.gov registry record · Phase 1
A Study of the Safety, Tolerability and Pharmacokinetics of ABBV-368 as a Single Agent and Combination in Subjects With Locally Advanced or Metastatic Solid Tumors
A Phase 1 study, sponsored by AbbVie.
- Completed
- Registry status
- Phase 1
- Development phase
- 139
- Enrollment target
NCT03071757: Completed Phase 1 study, sponsored by AbbVie.
NCT03071757 is a Phase 1 study that has completed, run by AbbVie. The registered enrollment target is 139 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (132% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03071757, a Phase 1 study, has completed, sponsored by AbbVie.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 139 participants
- Enrollment target
Study Summary
The primary purpose of this Phase 1, open-label study is to evaluate the safety, pharmacokinetics, and preliminary efficacy of ABBV-368 as a monotherapy and in combination with ABBV-181 in participants with locally advanced or metastatic solid tumors. The study will consist of 3 parts: ABBV-368 dose escalation, ABBV-368 tumor-specific dose expansion (triple negative breast cancer \[TNBC\] cohort and head and neck cancer cohort) and 18F-AraG Imaging Substudy.
Primary Outcome
Terminal half-life of ABBV-368
Interventions
- DRUG ABBV-181
- DRUG ABBV-368
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 139 participants |
| Start Date | 2017-03-21 |
| Est. Completion | 2022-04-13 |
| Phase | Phase 1 |
What the finished NCT03071757 record still lists
NCT03071757 is an interventional study that assigns participants to a tested intervention. The registered 139 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (132% higher).
The record links to 0 conditions, and to 2 interventions - of which ABBV-181 is the first listed.
NCT03071757 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03071757 about?
NCT03071757 is a clinical study titled "A Study of the Safety, Tolerability and Pharmacokinetics of ABBV-368 as a Single Agent and Combination in Subjects With Locally Advanced or Metastatic Solid Tumors". The primary purpose of this Phase 1, open-label study is to evaluate the safety, pharmacokinetics, and preliminary efficacy of ABBV-368 as a monotherapy and in combination with ABBV-181 in participants with locally advanced or metastatic solid tumors. The study will consist of 3 parts: ABBV-368 dose...
What is the current status of trial NCT03071757?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 139 participants. The study started on 2017-03-21. Estimated completion is 2022-04-13.
What interventions are being tested in trial NCT03071757?
The interventions under investigation include: ABBV-181 (DRUG), ABBV-368 (DRUG).
Who is sponsoring clinical trial NCT03071757?
This trial is sponsored by AbbVie, which has 526 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03071757's enrollment target sits among peer trials
139 418th of 2000 higher than 1,583 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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