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NCT06700070 · ClinicalTrials.gov registry record · Early Phase 1
A Phase 0 Multicenter Study of the Pharmacodynamic Effects of Intratumoral Microdose Administration of PBA-0111 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..
- Recruiting
- Registry status
- Early Phase 1
- Development phase
- 12
- Enrollment target
- 1
- Study location
NCT06700070: Recruiting Early Phase 1 study of Head and Neck Squamous Cell Carcinoma and Triple Negative Breast Cancer, sponsored by Pure Biologics S.A..
NCT06700070 is a Early Phase 1 study of Head and Neck Squamous Cell Carcinoma and Triple Negative Breast Cancer that is actively recruiting participants, run by Pure Biologics S.A.. The registered enrollment target is 12 participants, below the 117-participant average among 124 other Head and Neck Squamous Cell Carcinoma trials with a reported enrollment target (90% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06700070, a Early Phase 1 study of Head and Neck Squamous Cell Carcinoma and Triple Negative Breast Cancer, is actively recruiting participants, sponsored by Pure Biologics S.A..
- RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 12 participants
- Enrollment target
- 1
- Study location
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-0111 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., GARP, Cluster of Differentiation 16), biomarkers for cell death (e.g., cleaved caspase 3), natur
Conditions Studied
Interventions
- DRUG PBA-0111
Study Locations (1)
Louisiana
- LSU Health Sciences Center - Shreveport
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2025-03-27 |
| Est. Completion | 2025-12 |
| Phase | Early Phase 1 |
What NCT06700070 shows while recruiting
NCT06700070 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 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 (90% 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-0111 is the first listed.
NCT06700070 reports a single indexed study location in Louisiana.
Frequently Asked Questions
What is clinical trial NCT06700070 about?
NCT06700070 is a clinical study titled "A Phase 0 Multicenter Study of the Pharmacodynamic Effects of Intratumoral Microdose Administration of PBA-0111 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-0111 when administered intratumorally in microdose quantities via the CIVO device.
What is the current status of trial NCT06700070?
This trial is currently recruiting. It is a Early Phase 1 study. The enrollment target is 12 participants. The study started on 2025-03-27. Estimated completion is 2025-12.
What conditions does trial NCT06700070 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 NCT06700070?
The interventions under investigation include: PBA-0111 (DRUG).
Who is sponsoring clinical trial NCT06700070?
This trial is sponsored by Pure Biologics S.A., which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06700070 being conducted?
This trial has 1 study location across Louisiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06700070's enrollment target sits among peer trials
12 117th of 124 higher than 4 of 124 other Head and Neck Squamous Cell Carcinoma trials
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.
Source ClinicalTrials.gov registry export · 2026-08-08
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