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NCT05029999 · ClinicalTrials.gov registry record · Phase 1
CD40 Agonist, Flt3 Ligand, and Chemotherapy in HER2 Negative Breast Cancer
A Phase 1 study of Metastatic Breast Cancer and HER2-Negative Breast Cancer, sponsored by University of Texas Southwestern Medical Center.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
- 7
- Study locations
NCT05029999: Recruiting Phase 1 study of Metastatic Breast Cancer and HER2-Negative Breast Cancer, sponsored by University of Texas Southwestern Medical Center.
NCT05029999 is a Phase 1 study of Metastatic Breast Cancer and HER2-Negative Breast Cancer that is actively recruiting participants, run by University of Texas Southwestern Medical Center. The registered enrollment target is 30 participants, below the 205-participant average among 139 other Metastatic Breast Cancer trials with a reported enrollment target (85% lower). The trial reports 7 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05029999, a Phase 1 study of Metastatic Breast Cancer and HER2-Negative Breast Cancer, is actively recruiting participants, sponsored by University of Texas Southwestern Medical Center.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
- 7
- Study locations
Study Summary
This research study is being done to find out if the immunotherapy drugs called CDX-301 and CDX-1140 in combination with the standard chemotherapy treatment pegylated liposomal doxorubicin (PLD, Doxil) are safe and effective at controlling the cancer in patients with metastatic triple Human Epidermal Growth Factor Receptor 2 (HER2) negative breast cancer, and to determine a safe dose and treatment schedule of the three drugs. This research study will also test how your immune system responds to these treatments alone and in combination.
Primary Outcome
DLTs are defined as toxicities that meet pre-defined severity criteria including serious Hematologic/Non-Hematologic adverse events (AEs) and AEs at Grade 3 or above; Any ≥ grade 2 eye pain or reduction of visual acuity that does not improved to ≤ grade 1 severity within 2 weeks of initiation of topical therapy or requires systemic treatment. Based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0
Conditions Studied
Interventions
- DRUG PLD Chemotherapy
- DRUG CDX-1140
- DRUG CDX-301
Study Locations (7)
Texas
- Texas Oncology, P.A. - Dallas
- UT Southwestern Medical Center - Dallas
- The University of Texas Health Science Center at San Antonio - San Antonio
Illinois
- University of Chicago Comprehensive Cancer Center - Chicago
Maryland
- Johns Hopkins University - Baltimore
North Carolina
- University of North Carolina - Chapel Hill
Tennessee
- Sarah Cannon Research Institute - Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2022-04-20 |
| Est. Completion | 2026-04-20 |
| Phase | Phase 1 |
What NCT05029999 shows while recruiting
NCT05029999 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 205-participant average among 139 other Metastatic Breast Cancer trials with a reported enrollment target (85% lower).
The record links to 2 conditions, with Metastatic Breast Cancer appearing as the primary indexed condition, and to 3 interventions - of which PLD Chemotherapy is the first listed.
NCT05029999 lists 7 locations in 5 states (Texas, Illinois, Maryland).
Frequently Asked Questions
What is clinical trial NCT05029999 about?
NCT05029999 is a clinical study titled "CD40 Agonist, Flt3 Ligand, and Chemotherapy in HER2 Negative Breast Cancer". This research study is being done to find out if the immunotherapy drugs called CDX-301 and CDX-1140 in combination with the standard chemotherapy treatment pegylated liposomal doxorubicin (PLD, Doxil) are safe and effective at controlling the cancer in patients with metastatic triple Human Epiderma...
What is the current status of trial NCT05029999?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2022-04-20. Estimated completion is 2026-04-20.
What conditions does trial NCT05029999 study?
This clinical trial studies the following conditions: Metastatic Breast Cancer, HER2-Negative Breast Cancer.
What interventions are being tested in trial NCT05029999?
The interventions under investigation include: PLD Chemotherapy (DRUG), CDX-1140 (DRUG), CDX-301 (DRUG).
Who is sponsoring clinical trial NCT05029999?
This trial is sponsored by University of Texas Southwestern Medical Center, which has 837 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05029999 being conducted?
This trial has 7 study locations across Illinois, Maryland, North Carolina, Tennessee, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05029999's enrollment target sits among peer trials
30 105th of 139 higher than 31 of 139 other Metastatic Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Metastatic 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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