NCT06700070

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

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Pure Biologics S.A. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

CIVO is a research tool composed of a hand-held single-use sterile injector coupled with fluorescent tracking microspheres called CIVO GLO that mark the sites of drug microdose injection, enabling rapid assessment of multiple oncology drugs or drug combinations simultaneously within a patient's tumor. In this Phase 0 intratumoral microdosing study in human patients with localized or metastatic primary HNSCC, STS, or TNBC tumors (who will be undergoing previously planned tumor and regional nodes dissection), we will evaluate PBA-0111's ability to trigger a variety of immune-mediated effector functions that kill tumor cells, within the local tumor microenvironment. The CIVO device penetrates solid tumors and delivers subtherapeutic microdoses of up to eight anti-cancer agents or combinations of anti-cancer agents co-injected with CIVO GLO into discrete regions of the tumor. At the time of the planned surgical intervention (one to two days after the CIVO microdose injection), the injected tumor tissue is then excised, and tumor responses are assessed via histological staining of tumor cross-sections sampled perpendicular to each injection column. Co-injection with CIVO GLO enables identification of each injection site during resection as well as in tissues stained for analysis. Because the platform delivers microdose amounts of each test agent or combination directly into the patient's tumor tissue, hypotheses can be tested earlier in the drug development process, consistent with the goals of the 2006 FDA Exploratory IND Guidance for Industry.

Conditions

• Head and Neck Squamous Cell Carcinoma
• Soft Tissue Sarcoma Adult
• Triple Negative Breast Cancer

Interventions

Type	Name	Description
DRUG	PBA-0111	Intratumoral microdose injection by the CIVO device.

Timeline

• Start date: 2025-03-27
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2024-11-21
• Last updated: 2025-08-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study