Tiny, direct injections of PBA-0111 into solid tumors to see local immune and tumor responses
A Phase 0 Multicenter Study of the Pharmacodynamic Effects of Intratumoral Microdose Administration of PBA-0111 in Patients With Solid Tumors
This study will try tiny, localized injections of PBA-0111 into tumors of adults with head and neck cancer, selected soft-tissue sarcomas, or triple-negative breast cancer to see if it triggers immune activity and tumor cell killing in the tumor microenvironment.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 12 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Pure Biologics S.A. Industry-sponsored |
| Drugs / interventions | chemotherapy, immunotherapy, prednisone |
| Locations | 1 site (Shreveport, Louisiana) |
| Trial ID | NCT06700070 on ClinicalTrials.gov |
What this trial studies
This single-arm, open-label Phase 0 trial uses the CIVO device to deliver microdose injections of PBA-0111 directly into discrete regions of patients' tumors. Each injection is co-delivered with fluorescent CIVO GLO markers so the injection sites can be identified in the surgically resected tissue one to two days later. Excised tumor tissue will be analyzed by histology and immunologic biomarkers to measure local pharmacodynamic effects on tumor cells and immune effectors. Because doses are subtherapeutic and limited to the injected regions, the primary goal is to measure biological activity rather than provide systemic treatment.
Who should consider this trial
Good fit: Ideal candidates are adults with resectable HNSCC, one of the specified soft-tissue sarcoma subtypes, or triple-negative breast cancer who are scheduled for tumor resection and can consent to the microdosing and tissue collection.
Not a fit: Patients with unresectable disease, ineligible tumor subtypes, or who cannot undergo the planned surgery are unlikely to receive benefit from participation.
Why it matters
Potential benefit: If successful, this approach could show whether PBA-0111 triggers local immune-mediated tumor killing and help guide further drug development.
How similar studies have performed: The CIVO microdosing platform has shown feasibility in preclinical and early human work for mapping local drug responses, but PBA-0111's intratumoral effects in patients remain novel and unproven.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1\. Ability and willingness to comply with the study's visit and assessment schedule. 2. Male or female ≥ 18 years of age at Visit 1 (Screening). 3. 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. Note: For STS, only the following subtypes are eligible: undifferentiated pleomorphic sarcoma, alveolar soft part sarcoma, synovial sarcoma, cutaneous angiosarcoma, or myxofibrosarcoma. Note: For TNBC, if prior neoadjuvant therapy, evidence of progressive disease, at the discretion of the investigator. 4. 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. 5. 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. 6. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2. 7. Female patients who: • Are postmenopausal for at least one year before the screening visit, OR • Are surgically sterile, OR • Are of childbearing potential who agree to practice a highly effective method of contraception from the time of signing the ICF up to 3 months following the end of study participation OR agree to completely abstain from heterosexual intercourse. • Agree to refrain from donating ova during study participation. Male patients, even if surgically sterile (i.e., status post-vasectomy), who: • Agree to practice effective barrier contraception from the time of signing the ICF up to 3 months following the end of study participation OR agree to completely abstain from heterosexual intercourse. • Agree to refrain from donating sperm during study participation. Exclusion Criteria: 1\. Tumors near or involving critical structures for which, in the opinion of the treating clinician, injection would pose undue risk to the patient. 2. Female patients who are: • Both lactating and breastfeeding, OR • Have a positive β-subunit human chorionic gonadotropin (β-hCG) pregnancy test at screening verified by the Investigator. 3. 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. 4. HNSCC known to be of cutaneous origin. 5. Patients with uncontrolled autoimmune diseases (see Appendix 1 for examples) requiring systemic treatment 6. Patients with known HIV/AIDS. 7. 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. Note: Hepatitis B and C screening tests are not required unless: • Patient has a known history of hepatitis B/C infection • Mandated by local health authority 8. Use of any of the following ≤ 3 weeks prior to CIVO injection: a. Systemic anti-cancer therapy (e.g., cytotoxic chemotherapy, targeted agents, or checkpoint inhibitor immunotherapy, etc.), b. Immunosuppressive drugs (e.g., calcineurin inhibitors) c. Biological response modifiers for autoimmune disease d. Systemic glucocorticoids: oral or parenteral corticosteroids at a dose ≥ 20 mg/day prednisone, or equivalent Note: physiologic replacement dosing of steroids (≤ 3 mg/m2/d prednisone or equivalent), low-dose corticosteroids for dye allergies prior to staging scans or use in anti-emetic prophylaxis for patients undergoing chemotherapy, or topical steroids, are allowed e. Hematopoietic growth factors f. Chemotherapy g. Local radiotherapy of the target lesion planned for CIVO injection and surgical resection 9. Patients who have received a live or live attenuated vaccine within 4 weeks of the baseline/screening visit. 10. Patients who have had allogenic tissue/solid organ transplant 11. Patients with an active infection requiring systemic therapy. 12. Patients for whom participation on this study results in a delay of planned surgical intervention.
Where this trial is running
Shreveport, Louisiana
- LSU Health Sciences Center — Shreveport, Louisiana, United States (Recruiting)
Study contacts
- Study coordinator: Presage Biosciences
- Email: clinops@presagebio.com
- Phone: 800-530-5404
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.