A Phase 0 Multicenter Study of the Pharmacodynamic Effects of Intratumoral Microdose Administration of PBA-0111 in Patients With Solid Tumors
NCT06700070 · Status: RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 12
Last updated 2025-08-11
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.
Conditions
- Head and Neck Squamous Cell Carcinoma
- Soft Tissue Sarcoma Adult
- Triple Negative Breast Cancer
Interventions
- DRUG
-
PBA-0111
Intratumoral microdose injection by the CIVO device.
Sponsors & Collaborators
-
Pure Biologics S.A.
lead INDUSTRY
Principal Investigators
-
John Weinberg, MBBCH · Pure Biologics
Study Design
- Allocation
- NA
- Purpose
- BASIC_SCIENCE
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-03-27
- Primary Completion
- 2025-12-31
- Completion
- 2025-12-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
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