A Study of the Intratumoral Microdose Administration of PBA-0405 in Patients With Solid Tumors (NCT06273852) | Clinical Trial Compass
CompletedEarly Phase 1
A Study of the Intratumoral Microdose Administration of PBA-0405 in Patients With Solid Tumors
United States8 participantsStarted 2024-04-29
Plain-language 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-0405 when administered intratumorally in microdose quantities via the CIVO device.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Ability and willingness to comply with the study's visit and assessment schedule.
✓. Male or female ≥ 18 years of age at Visit 1 (Screening).
✓. Pathologic diagnosis of HNSCC, STS (see restrictions in Note below), or TNBC (see restrictions in Note below; TNBC defined as estrogen receptor negative \[\<1% positive tumor cells\], progesterone receptor negative \[\<1% positive tumor cells\], and human epidermal growth factor receptor 2 negative \[0 to 1+\]) with a tumor planned for surgical resection.
✓. Ability and willingness to provide written informed consent. Voluntary written consent must be given before performance of any study related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care.
✓. As assessed or confirmed by the surgeon, at least one lesion (primary tumor, recurrent tumor, metastatic tumor, or metastatic lymph node) that is surface accessible for CIVO injection that contains viable minimum tumor tissue volume and characteristics (e.g., based on clinical evaluation, available pre-operative imaging, pre-injection ultrasound imaging, or pathology reports indicating lesion with appropriate viable tumor volume without excessive cysts or necrosis) and for which there is a planned surgical intervention. The patient's presentation, surgical and pathology plan may determine whether a lesion is eligible with respect to a given CIVO MID needle configuration.
✓. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
✓. Female patients who:
Exclusion criteria
✕. Tumors near or involving critical structures for which, in the opinion of the treating clinician, injection would pose undue risk to the patient.
What they're measuring
1
Quantification of Cell Death and Immune Cell Biomarkers by immuno-histochemistry (IHC) and In-Situ Hybridization (ISH)
✕. Any uncontrolled intercurrent illness, condition, serious medical or psychiatric illness, or circumstance that, in the opinion of the Investigator, could interfere with adherence to the study's procedures or requirements, or otherwise compromise the study's objectives.
✕. HNSCC known to be of cutaneous origin.
✕. Patients with uncontrolled autoimmune diseases (see Appendix 1 for examples) requiring systemic treatment
✕. Patients with known HIV/AIDS.
✕. Patients with known uncontrolled active hepatitis B (defined as hepatitis B surface antigen \[HBsAg\] positive or detectable hepatitis B virus \[HBV\] DNA) or hepatitis C (defined as anti-hepatitis C virus antibody \[anti-HCV Ab\] positive and detectable hepatitis C virus \[HCV\] RNA) infection.
✕. Use of any of the following ≤ 3 weeks prior to CIVO injection: