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NCT06273852 · ClinicalTrials.gov registry record · Early Phase 1
A Study of the Intratumoral Microdose Administration of PBA-0405 in Patients With Solid Tumors
A Early Phase 1 study of Head and Neck Squamous Cell Carcinoma and Triple Negative Breast Cancer, sponsored by Pure Biologics S.A..
- Completed
- Registry status
- Early Phase 1
- Development phase
- 8
- Enrollment target
- 4
- Study locations
NCT06273852: Completed Early Phase 1 study of Head and Neck Squamous Cell Carcinoma and Triple Negative Breast Cancer, sponsored by Pure Biologics S.A..
NCT06273852 is a Early Phase 1 study of Head and Neck Squamous Cell Carcinoma and Triple Negative Breast Cancer that has completed, run by Pure Biologics S.A.. The registered enrollment target is 8 participants, below the 117-participant average among 124 other Head and Neck Squamous Cell Carcinoma trials with a reported enrollment target (93% lower). The trial reports 4 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06273852, a Early Phase 1 study of Head and Neck Squamous Cell Carcinoma and Triple Negative Breast Cancer, has completed, sponsored by Pure Biologics S.A..
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 8 participants
- Enrollment target
- 4
- Study locations
Study Summary
This is a multi-center, single arm, open-label, localized pharmacodynamic biomarker Phase 0 trial designed to study the biological effects within the tumor microenvironment of PBA-0405 when administered intratumorally in microdose quantities via the CIVO device.
Primary Outcome
Quantification of biomarker-positive and biomarker-negative cells will be performed within the tumor microenvironment around each of the injection sites in each resected patient sample by IHC and/or ISH. An aggregate analysis of this quantification may be done across patient samples to evaluate trends in tumor response. The biomarkers evaluated may include, but are not limited to, drug targets (e.g., ROR1, Cluster of Differentiation 16), biomarkers for cell death (e.g., cleaved caspase 3), natur
Conditions Studied
Interventions
- DRUG PBA-0405
Study Locations (4)
Louisiana
- LSU Health Sciences Center - Shreveport
Oregon
- Oregon Health and Science University - Portland
Pennsylvania
- University of Pennsylvania - Philadelphia
South Carolina
- Sarah Cannon Research Institute - Charleston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2024-04-29 |
| Est. Completion | 2025-03-31 |
| Phase | Early Phase 1 |
What the finished NCT06273852 record still lists
NCT06273852 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 117-participant average among 124 other Head and Neck Squamous Cell Carcinoma trials with a reported enrollment target (93% lower).
The record links to 3 conditions, with Head and Neck Squamous Cell Carcinoma appearing as the primary indexed condition, and to 1 intervention - of which PBA-0405 is the first listed.
NCT06273852 reports a single indexed study location in Louisiana, Oregon, Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT06273852 about?
NCT06273852 is a clinical study titled "A Study of the Intratumoral Microdose Administration of PBA-0405 in Patients With Solid Tumors". This is a multi-center, single arm, open-label, localized pharmacodynamic biomarker Phase 0 trial designed to study the biological effects within the tumor microenvironment of PBA-0405 when administered intratumorally in microdose quantities via the CIVO device.
What is the current status of trial NCT06273852?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 8 participants. The study started on 2024-04-29. Estimated completion is 2025-03-31.
What conditions does trial NCT06273852 study?
This clinical trial studies the following conditions: Head and Neck Squamous Cell Carcinoma, Triple Negative Breast Cancer, Soft Tissue Sarcoma Adult.
What interventions are being tested in trial NCT06273852?
The interventions under investigation include: PBA-0405 (DRUG).
Who is sponsoring clinical trial NCT06273852?
This trial is sponsored by Pure Biologics S.A., which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06273852 being conducted?
This trial has 4 study locations across Louisiana, Oregon, Pennsylvania, South Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06273852's enrollment target sits among peer trials
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participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Head and Neck Squamous Cell Carcinoma 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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