COMPLETED

A Study of the Intratumoral Microdose Administration of PBA-0405 in Patients With Solid Tumors

Conditions

Head and Neck Squamous Cell Carcinoma Soft Tissue Sarcoma Adult Triple Negative Breast Cancer Pure Biologics PBA-0405 TNBC STS HNSCC tumor microenvironment in vivo drug sensitivity in vivo oncology microdosing microinjection intratumoral microdosing precision oncology

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Phase 0 Multicenter Study of the Pharmacodynamic Effects of Intratumoral Microdose Administration of PBA-0405 in Patients With Solid Tumors

Quick Facts

Study Start:2024-04-29

Study Completion:2025-03-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT06273852

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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. 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of any study related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care. 5.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. * 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.	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. * 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: 1. Systemic anti-cancer therapy (e.g., cytotoxic chemotherapy, targeted agents, or checkpoint inhibitor immunotherapy, etc.), 2. Immunosuppressive drugs (e.g., calcineurin inhibitors) 3. Biological response modifiers for autoimmune disease 4. 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 5. Hematopoietic growth factors 6. Chemotherapy 7. 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.

Inclusion Criteria

Exclusion 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.
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.
* 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.

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.
* 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:
1. Systemic anti-cancer therapy (e.g., cytotoxic chemotherapy, targeted agents, or checkpoint inhibitor immunotherapy, etc.),
2. Immunosuppressive drugs (e.g., calcineurin inhibitors)
3. Biological response modifiers for autoimmune disease
4. 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
5. Hematopoietic growth factors
6. Chemotherapy
7. 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.

Contacts and Locations

Principal Investigator

John Weinberg

STUDY_DIRECTOR

Pure Biologics

Study Locations (Sites)

LSU Health Sciences Center

Shreveport, Louisiana, 71115

United States

Oregon Health and Science University

Portland, Oregon, 97239

United States

University of Pennsylvania

Philadelphia, Pennsylvania, 19107

United States

Sarah Cannon Research Institute

Charleston, South Carolina, 29406

United States

Collaborators and Investigators

Sponsor: Pure Biologics S.A.

John Weinberg, STUDY_DIRECTOR, Pure Biologics

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-04-29

Study Completion Date2025-03-31

Study Record Updates

Study Start Date2024-04-29

Study Completion Date2025-03-31

Terms related to this study

Keywords Provided by Researchers

Pure Biologics
PBA-0405
TNBC
STS
HNSCC
tumor microenvironment
in vivo drug sensitivity
in vivo oncology
microdosing
microinjection
intratumoral microdosing
precision oncology

Additional Relevant MeSH Terms

Head and Neck Squamous Cell Carcinoma
Soft Tissue Sarcoma Adult
Triple Negative Breast Cancer