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NCT03639194 · ClinicalTrials.gov registry record · Phase 1
A Study of ABBV-011 Alone and in Combination With Budigalimab (ABBV-181) in Participants With Relapsed or Refractory Small Cell Lung Cancer
A Phase 1 study, sponsored by AbbVie.
- Completed
- Registry status
- Phase 1
- Development phase
- 132
- Enrollment target
NCT03639194 is a Phase 1 study that has completed, run by AbbVie. The registered enrollment target is 132 participants.
The verdict
NCT03639194, a Phase 1 study, has completed, sponsored by AbbVie.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 132 participants
- Enrollment target
Study Summary
This is a multicenter, open-label, Phase 1 study of ABBV-011 given as a single agent and in combination with budigalimab (ABBV-181) in participants with relapsed or refractory small cell lung cancer (SCLC). The study consists of 4 parts: Part A is a single-agent ABBV-011 dose regimen finding cohort; followed by Part B, a single-agent ABBV-011 dose expansion cohort; and then Part C, an ABBV-011 and budigalimab (ABBV-181) combination escalation and expansion cohort; Part D, single-agent ABBV-011 dose-evaluating cohort for Japan.
Interventions
- DRUG Budigalimab
- DRUG ABBV-011
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 132 participants |
| Start Date | 2018-10-24 |
| Est. Completion | 2024-01-25 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03639194
The ClinicalTrials.gov registry entry for NCT03639194 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 132 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AbbVie, which has 526 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Budigalimab is the first listed.
NCT03639194 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03639194 about?
NCT03639194 is a clinical study titled "A Study of ABBV-011 Alone and in Combination With Budigalimab (ABBV-181) in Participants With Relapsed or Refractory Small Cell Lung Cancer". This is a multicenter, open-label, Phase 1 study of ABBV-011 given as a single agent and in combination with budigalimab (ABBV-181) in participants with relapsed or refractory small cell lung cancer (SCLC). The study consists of 4 parts: Part A is a single-agent ABBV-011 dose regimen finding cohort;...
What is the current status of trial NCT03639194?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 132 participants. The study started on 2018-10-24. Estimated completion is 2024-01-25.
What interventions are being tested in trial NCT03639194?
The interventions under investigation include: Budigalimab (DRUG), ABBV-011 (DRUG).
Who is sponsoring clinical trial NCT03639194?
This trial is sponsored by AbbVie, which has 526 total clinical trials registered on ClinicalTrials.gov.
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