Actively Recruiting
A Phase 0 Multicenter Study of the Pharmacodynamic Effects 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
35 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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 aged 18 years or older
- Diagnosed with head and neck squamous cell carcinoma, specific soft tissue sarcoma subtypes, or triple-negative breast cancer with planned tumor surgery
- Able and willing to provide written informed consent
- At least one tumor lesion accessible for CIVO injection with viable tumor tissue and planned surgery
- ECOG performance status of 0 to 2
- Female patients must be postmenopausal for at least one year, surgically sterile, or agree to use effective contraception or abstain from heterosexual intercourse during and 3 months after the study
- Male patients must agree to use barrier contraception or abstain from heterosexual intercourse during and 3 months after the study
- Agree to refrain from donating eggs (females) or sperm (males) during the study
You will not qualify if you...
- Tumors near critical structures posing undue injection risk
- Female patients who are both lactating and breastfeeding or have a positive pregnancy test
- Any uncontrolled illness or serious medical or psychiatric condition interfering 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, high-dose systemic glucocorticoids, hematopoietic growth factors, chemotherapy, or local radiotherapy to the target lesion within 3 weeks before injection
- Receipt of live or live attenuated vaccine within 4 weeks before screening
- History of allogenic tissue or solid organ transplant
- Active infection requiring systemic therapy
- Participation causing delay in planned surgery
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
LSU Health Sciences Center
Shreveport, Louisiana, United States, 71115
Actively Recruiting
Research Team
P
Presage Biosciences
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
BASIC_SCIENCE
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here