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NCT03629756 · ClinicalTrials.gov registry record · Phase 1
A Study to Evaluate the Safety and Tolerability of Immunotherapy Combinations in Participants With Advanced Malignancies
A Phase 1 study of Breast Cancer and Non-Small Cell Lung Cancer, sponsored by Arcus Biosciences.
- Completed
- Registry status
- Phase 1
- Development phase
- 48
- Enrollment target
- 15
- Study locations
NCT03629756: Completed Phase 1 study of Breast Cancer and Non-Small Cell Lung Cancer, sponsored by Arcus Biosciences.
NCT03629756 is a Phase 1 study of Breast Cancer and Non-Small Cell Lung Cancer that has completed, run by Arcus Biosciences. The registered enrollment target is 48 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (98% lower). The trial reports 15 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03629756, a Phase 1 study of Breast Cancer and Non-Small Cell Lung Cancer, has completed, sponsored by Arcus Biosciences.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 48 participants
- Enrollment target
- 15
- Study locations
Study Summary
This is a Phase 1, open-label, dose-escalation and dose-expansion study to evaluate the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD) and clinical activity of etrumadenant (AB928) in combination with zimberelimab (AB122) (an anti-PD-1 antibody) in participants with advanced malignancies.
Primary Outcome
Safety will be assessed by monitoring adverse events and clinically relevant changes in Eastern Cooperative Oncology Group (ECOG) performance status, 12 lead Electrocardiogram (ECG), vital signs, physical examination and clinical laboratory results.
Conditions Studied
Interventions
- DRUG Zimberelimab
- DRUG Etrumadenant
Study Locations (15)
Texas
- Texas Oncology, P.A. - Fort Worth Cancer Center - Fort Worth
- Texas Oncology, P.A. - San Antonio Medical Center - San Antonio
- Texas Oncology, P.A. - Tyler - Tyler
California
- University of California, Los Angeles - Los Angeles
- The Angeles Clinic and Research Institute - Los Angeles
Michigan
- University of Michigan - Ann Arbor
- QUEST Research Institute - Royal Oak
Arizona
- Scottsdale Healthcare Hospitals dba HonorHealth - Scottsdale
Colorado
- Rocky Mountain Cancer Centers (Midtown) - Denver
North Carolina
- Carolina BioOncology Institute - Huntersville
South Carolina
- Prisma Health - Greenville
Washington
- Medical Oncology Associates dba Summit Cancer Centers - Spokane
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2018-07-24 |
| Est. Completion | 2021-09-03 |
| Phase | Phase 1 |
What the finished NCT03629756 record still lists
NCT03629756 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (98% lower).
The record links to 10 conditions, with Breast Cancer appearing as the primary indexed condition, and to 2 interventions - of which Zimberelimab is the first listed.
NCT03629756 lists 15 locations in 11 states (Texas, California, Michigan).
Frequently Asked Questions
What is clinical trial NCT03629756 about?
NCT03629756 is a clinical study titled "A Study to Evaluate the Safety and Tolerability of Immunotherapy Combinations in Participants With Advanced Malignancies". This is a Phase 1, open-label, dose-escalation and dose-expansion study to evaluate the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD) and clinical activity of etrumadenant (AB928) in combination with zimberelimab (AB122) (an anti-PD-1 antibody) in participants with advanced malign...
What is the current status of trial NCT03629756?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 48 participants. The study started on 2018-07-24. Estimated completion is 2021-09-03.
What conditions does trial NCT03629756 study?
This clinical trial studies the following conditions: Breast Cancer, Non-Small Cell Lung Cancer, Colorectal Cancer, Ovarian Cancer, Melanoma.
What interventions are being tested in trial NCT03629756?
The interventions under investigation include: Zimberelimab (DRUG), Etrumadenant (DRUG).
Who is sponsoring clinical trial NCT03629756?
This trial is sponsored by Arcus Biosciences, which has 25 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03629756 being conducted?
This trial has 15 study locations across Arizona, California, Colorado, Michigan, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT03629756's enrollment target sits among peer trials
48 821st of 1224 higher than 394 of 1,224 other Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Breast 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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