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NCT06878248 · ClinicalTrials.gov registry record · Phase 1
A Study to Assess CLBR001+ABBV-461 in Subjects With Locally Advanced or Metastatic Breast Cancer
A Phase 1 study of Hormone Receptor-Positive Breast Cancer and Breast Cancer Metastatic, sponsored by Calibr, a division of Scripps Research.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
- 5
- Study locations
NCT06878248: Recruiting Phase 1 study of Hormone Receptor-Positive Breast Cancer and Breast Cancer Metastatic, sponsored by Calibr, a division of Scripps Research.
NCT06878248 is a Phase 1 study of Hormone Receptor-Positive Breast Cancer and Breast Cancer Metastatic that is actively recruiting participants, run by Calibr, a division of Scripps Research. The registered enrollment target is 20 participants, below the 187-participant average among 23 other Hormone Receptor-Positive Breast Cancer trials with a reported enrollment target (89% lower). The trial reports 5 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06878248, a Phase 1 study of Hormone Receptor-Positive Breast Cancer and Breast Cancer Metastatic, is actively recruiting participants, sponsored by Calibr, a division of Scripps Research.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
- 5
- Study locations
Study Summary
The goal of this clinical trial is to evaluate CLBR001 and ABBV-461 as a treatment for patients with locally advanced or metastatic breast cancer. The goals are to establish the safety and efficacy of the combination therapy while establishing the optimal biologic doses. Patients will be administered a single infusion of CLBR001 cells followed by cycles of ABBV-461 with regular assessments of safety and disease response to treatment.
Primary Outcome
To assess the safety and tolerability in subjects by evaluating the frequency, relatedness, severity and duration of adverse events, as assessed by CTCAE v5.0 and ASTCT consensus grading criteria for CRS and ICANS.
Conditions Studied
Interventions
- BIOLOGICAL Two Component Product CLBR001 + ABBV-461
Study Locations (5)
Georgia
- Augusta University Medical Center - Augusta
Indiana
- Indiana University Melvin and Bren Simon Comprehensive Cancer Center - Indianapolis
New York
- Roswell Park Cancer Institute - Buffalo
Virginia
- University of Virginia - Charlottesville
Washington
- Fred Hutchinson Cancer Center - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2025-04-17 |
| Est. Completion | 2028-11 |
| Phase | Phase 1 |
What NCT06878248 shows while recruiting
NCT06878248 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 187-participant average among 23 other Hormone Receptor-Positive Breast Cancer trials with a reported enrollment target (89% lower).
The record links to 6 conditions, with Hormone Receptor-Positive Breast Cancer appearing as the primary indexed condition, and to 1 intervention - of which Two Component Product CLBR001 + ABBV-461 is the first listed.
NCT06878248 lists 5 locations in 5 states (Georgia, Indiana, New York).
Frequently Asked Questions
What is clinical trial NCT06878248 about?
NCT06878248 is a clinical study titled "A Study to Assess CLBR001+ABBV-461 in Subjects With Locally Advanced or Metastatic Breast Cancer". The goal of this clinical trial is to evaluate CLBR001 and ABBV-461 as a treatment for patients with locally advanced or metastatic breast cancer. The goals are to establish the safety and efficacy of the combination therapy while establishing the optimal biologic doses. Patients will be administer...
What is the current status of trial NCT06878248?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2025-04-17. Estimated completion is 2028-11.
What conditions does trial NCT06878248 study?
This clinical trial studies the following conditions: Hormone Receptor-Positive Breast Cancer, Breast Cancer Metastatic, Triple Negative Breast Cancer (TNBC), Malignant Neoplasm of Breast, HER2 + Breast Cancer.
What interventions are being tested in trial NCT06878248?
The interventions under investigation include: Two Component Product CLBR001 + ABBV-461 (BIOLOGICAL).
Who is sponsoring clinical trial NCT06878248?
This trial is sponsored by Calibr, a division of Scripps Research, which has 7 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06878248 being conducted?
This trial has 5 study locations across Georgia, Indiana, New York, Virginia, Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Hormone Receptor-Positive Breast Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06878248's enrollment target sits among peer trials
20 22nd of 23 higher than 1 of 23 other Hormone Receptor-Positive Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hormone Receptor-Positive 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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