Actively Recruiting
Phase 0 Multicenter Study of Intratumoral Microdose Administration of PBA-0111 in Patients With Solid Tumors
Led by Pure Biologics S.A. · Updated on 2025-08-11
12
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of a drug called PBA-0111 when given in very small doses directly into tumors in patients with certain solid tumors. This Phase 0 trial focuses on head and neck squamous cell carcinoma, soft tissue sarcoma, and triple negative breast cancer. The goal is to study how PBA-0111 affects the tumor environment and triggers immune responses that may kill cancer cells. The study uses a special CIVO device that injects microdoses of PBA-0111 directly into the tumor tissue in up to eight small areas. This is done 1 to 2 days before the patient's planned surgery to remove the tumor or affected lymph nodes. Alongside PBA-0111, a control solution (sterile saline) is also injected to compare responses. The injected tumor tissue is then removed during surgery for detailed analysis. Participants will undergo injection with the CIVO device before their surgery, after which the removed tumor samples are examined using advanced staining techniques to measure cell death and immune activity. Researchers will also monitor any adverse events for up to 28 days after injection. The study aims to understand the drug's biological effects within a short time frame and involves careful follow-up during this period.
CONDITIONS
Brief Title
A Phase 0 Multicenter Study of the Pharmacodynamic Effects of Intratumoral Microdose Administration of PBA-0111 in Patients With Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able and willing to follow the study visit and assessment schedule
- Male or female 18 years of age or older at screening
- Pathologic diagnosis of head and neck squamous cell carcinoma, specific subtypes of soft tissue sarcoma, or triple negative breast cancer with a tumor planned for surgical removal
- Willing and able to provide written informed consent
- At least one tumor lesion accessible for injection with the CIVO device and planned surgical intervention
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- Women who are postmenopausal for at least one year, surgically sterile, or agree to effective contraception or abstinence during and after the study; men agree to effective contraception or abstinence during and after the study
You will not qualify if you...
- Tumors near critical structures where injection poses undue risk
- Women who are both lactating and breastfeeding or have a positive pregnancy test
- Any uncontrolled illness or serious medical or psychiatric condition that interferes with study adherence
- Head and neck squamous cell carcinoma of cutaneous origin
- Uncontrolled autoimmune diseases requiring systemic treatment
- Known HIV/AIDS infection
- Known uncontrolled active hepatitis B or C infection
- Use of systemic anti-cancer therapy, immunosuppressive drugs, biological response modifiers, or high-dose corticosteroids within 3 weeks prior to injection
- Local radiotherapy planned for target lesion
- Receipt of live or live attenuated vaccine within 4 weeks before screening
- History of allogenic tissue or organ transplant
- Active infection requiring systemic therapy
- Participation causing delay of planned surgery
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 to 2 days
Participants receive intratumoral microdose injection of PBA-0111 using the CIVO device 1 to 2 days prior to their planned surgery.
1 visit (in-person)
Duration - 1 day
Participants undergo planned tumor and regional nodes dissection surgery to excise the injected tumor tissue for assessment.
1 surgical visit (in-person)
Duration - Up to 28 days
Participants are monitored for safety and adverse events following the microdose injection and surgery.
Periodic follow-up visits up to 28 days
Trial Site Locations
Total: 1 location
1
LSU Health Sciences Center
Shreveport, Louisiana, United States, 71115
Actively Recruiting
Research Team
P
Presage Biosciences
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
BASIC_SCIENCE
Number of Arms
1
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