RecruitingEarly Phase 1NCT06700070

A Phase 0 Multicenter Study of the Pharmacodynamic Effects of Intratumoral Microdose Administration of PBA-0111 in Patients With Solid Tumors


Sponsor

Pure Biologics S.A.

Enrollment

12 participants

Start Date

Mar 27, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This early-stage study is testing a new drug (PBA-0111) by injecting tiny amounts directly into a tumor before it is surgically removed, to see how the drug affects cancer cells. It is studying people with head and neck cancer, certain soft tissue sarcomas, or triple-negative breast cancer who are already scheduled for surgery. **You may be eligible if...** - You are 18 or older - You have been diagnosed with head and neck squamous cell carcinoma (HNSCC), certain types of soft tissue sarcoma, or triple-negative breast cancer - You are scheduled to have your tumor surgically removed - Your tumor is accessible for a direct injection **You may NOT be eligible if...** - Your specific cancer type is not one of those listed in the study (e.g., not all soft tissue sarcomas qualify) - You are not able or willing to give written consent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPBA-0111

Intratumoral microdose injection by the CIVO device.


Locations(1)

LSU Health Sciences Center

Shreveport, Louisiana, United States

View Full Details on ClinicalTrials.gov

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NCT06700070


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