Head and Neck Squamous Cell CarcinomaEarly Phase 1NCT06700070
A Phase 0 Multicenter Study of the Pharmacodynamic Effects of Intratumoral Microdose Administration of PBA-0111 in Patients With Solid Tumors
A Early Phase 1 study testing PBA-0111 in people with Head and Neck Squamous Cell Carcinoma and Soft Tissue Sarcoma Adult, run by Pure Biologics S.A. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Squamous Cell Carcinoma, Soft Tissue Sarcoma Adult, Triple Negative Breast Cancer
- What is being tested?
- PBA-0111
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Mar 2025to Dec 2025
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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of any study related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care. 5.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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
LSU Health Sciences Center
Shreveport, Louisiana, 71115
About this study
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.
Read the 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
- Being tested
- PBA-0111
- Keywords
- Pure Biologics, PBA-0111, TNBC, STS, HNSCC, tumor microenvironment, in vivo drug sensitivity, in vivo oncology, microdosing, microinjection, intratumoral injection, precision oncology
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck, Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PBA-0111Drug
Intratumoral microdose injection by the CIVO device.
| Study group | Role | What they receive |
|---|---|---|
| PBA-0111 | Experimental | Patients who are scheduled for surgical biopsy or tumor resection surgery will be injected at 1-2 days prior to surgery using the CIVO device. Each needle of the CIVO device will deliver up to 8.3 microliters of solution, including a vehicle control (sterile saline) or subtherapeutic microdoses of PBA-0111, as single agents. Each microdose is simultaneously injected in a columnar fashion through each of 8, or 5, (in a device configuration determined by tumor dimensions) into a single solid tumor or effaced metastatic lymph node Receives: Drug: PBA-0111 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantification of Cell Death and Immune Cell Biomarkers by immuno-histochemistry (IHC) and In-Situ Hybridization (ISH)
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).
Measured: 1-2 days after microdose
Secondary outcomes (1)
Number of Patients with Adverse Events
Relationship of adverse event (AE) to study drug(s) or CIVO device will be determined using an AE Relatedness Grading System
Measured: Up to 28 days after microdose injection.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2024
- Study start27 Mar 2025
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck Squamous Cell CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is an exploratory clinical trial to evaluate intratumoral mechanistic effects of novel and approved agents on intact human tumors. This substudy is not blinded.
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pure Biologics S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- John Weinberg, MBBCH, Study director, Pure Biologics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06700070
- Sponsor's protocol ID
- PBL-0111-01
- Status last verified
- Mar 2025
- First submitted
- 19 Nov 2024
- Last updated
- 11 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 0 Multicenter Study of the Pharmacodynamic Effects of Intratumoral Microdose Administration of PBA-0111 in Patients With Solid Tumors
- ClinicalTrials.gov ID
- NCT06700070
- Acronym / sponsor ID
- PBL-0111-01
- Conditions
- Head and Neck Squamous Cell Carcinoma, Soft Tissue Sarcoma Adult, Triple Negative Breast Cancer
- Keywords
- Pure Biologics, PBA-0111, TNBC, STS, HNSCC, tumor microenvironment, in vivo drug sensitivity, in vivo oncology
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Pure Biologics S.A.Industry (pharma, biotech, devices)
- Study start
- 27 Mar 2025 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 21 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is an exploratory clinical trial to evaluate intratumoral mechanistic effects of novel and approved agents on intact human tumors. This substudy is not blinded.
| Arm | Type | Receives |
|---|---|---|
| PBA-0111 | Experimental | Drug: PBA-0111Patients who are scheduled for surgical biopsy or tumor resection surgery will be injected at 1-2 days prior to surgery using the CIVO device. Each needle of the CIVO device will deliver up to 8.3 microliters of solution, including a vehicle control (sterile saline) or subtherapeutic microdoses of PBA-0111, as single agents. Each microdose is simultaneously injected in a columnar fashion through each of 8, or 5, (in a device configuration determined by tumor dimensions) into a single solid tumor or effaced metastatic lymph node |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PBA-0111Intratumoral microdose injection by the CIVO device. | Drug | PBA-0111 |
Primary outcome
Quantification of Cell Death and Immune Cell Biomarkers by immuno-histochemistry (IHC) and In-Situ Hybridization (ISH)
Time frame: 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).
1 secondary outcome
Number of Patients with Adverse Events
Time frame: Up to 28 days after microdose injection.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
John Weinberg, MBBCH study director
Pure Biologics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing PBA-0111 in people with Head and Neck Squamous Cell Carcinoma and Soft Tissue Sarcoma Adult, run by Pure Biologics S.A. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Presage Biosciences (800-530-5404, clinops@presagebio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantification of Cell Death and Immune Cell Biomarkers by immuno-histochemistry (IHC) and In-Situ Hybridization (ISH) (time frame: 1-2 days after microdose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2025.