Phase 0 Study of PBA-0111 for Solid Tumors

This study is testing a drug called PBA-0111 in people with head and neck squamous cell carcinoma (a type of cancer that starts in the moist linings of the body), soft tissue sarcoma (cancer that forms in the soft tissues of the body), or triple negative breast cancer. Researchers will inject very small amounts (microdoses) of PBA-0111 directly into your tumor using a special device called CIVO. The goal is to see how PBA-0111 affects cancer cells and immune cells within the tumor. This is a small study, planning to include 12 participants. To join, you must be at least 18 years old and have one of the specified cancer types. The study will measure changes in cell death and immune cells within your tumor one to two days after the injection to understand how the drug works.

Study design
This is a single-arm, open-label study, meaning all participants will receive the same treatment and both you and the researchers will know what treatment is being given. It aims to enroll 12 participants.
What's involved
You will receive an intratumoral microdose injection of PBA-0111. One to two days later, the injected tumor tissue will be removed as part of a previously planned surgery.
Compensation
Not stated in the trial record.
Follow-up
Tumor responses are assessed one to two days after the microdose injection, at the time of planned surgical intervention.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06700070

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

Recruiting
EARLY_PHASE1Ages 18+InterventionalBasic science
Pure Biologics S.A.
~12 participants
Updated 2025-08-11 on ClinicalTrials.gov
What's tested:PBA-0111

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Quantification of Cell Death and Immune Cell Biomarkers by immuno-histochemistry (IHC) and In-Situ Hybridization (ISH)
Measured over 1-2 days after microdose
Head and Neck Squamous Cell Carcinoma
Soft Tissue Sarcoma Adult
Triple Negative Breast Cancer
1 sites across 1 states
Louisiana1
  • John Weinberg, MBBCH · STUDY_DIRECTOR · Pure Biologics

Opens a ready-to-send draft in your own email app — review before sending.

  • Quantification of Cell Death and Immune Cell Biomarkers by immuno-histochemistry (IHC) and In-Situ Hybridization (ISH)1-2 days after microdose

    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), natural killer cells (e.g., Cluster of Differentiation 56/Cluster of Differentiation 45/Granzyme B), macrophages (Cluster of Differentiation 86, Cluster of Differentiation 68, Cluster of Differentiation 163), and proinflammatory cytokines (e.g., interferon gamma, tumor necrosis factor alpha, interferon-stimulated gene 15, chemokine interferon gamma-inducible protein 10).