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Virus Therapy

PBA-0405 for Cancer

Phase < 1
Recruiting
Research Sponsored by Pure Biologics S.A.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male or female ≥ 18 years of age at Visit 1 (Screening)
Pathologic diagnosis of HNSCC, STS, or TNBC with a tumor planned for surgical resection
Must not have
Active infection requiring systemic therapy
Female patients who are lactating and breastfeeding or have a positive pregnancy test
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1-2 days after microdose injection
Awards & highlights

Summary

This trial aims to study the effects of a drug called PBA-0405 on tumors by administering it directly into the tumor in small amounts using a special device.

Who is the study for?
Adults over 18 with certain solid tumors (like oral, breast cancer, or sarcoma) that are planned for surgery can join. They must be able to follow the study plan and agree not to donate eggs or sperm. Women should be postmenopausal, surgically sterile, or use contraception. People with specific types of sarcoma are eligible.
What is being tested?
The trial is testing PBA-0405's effects on tumor biology when given in tiny amounts directly into the tumor using a special device called CIVO. It's an early-phase study where everyone gets the same treatment to see how it works inside the tumor.
What are the potential side effects?
Since this is a Phase 0 trial focusing on microdoses of PBA-0405 to assess biological effects within tumors, detailed side effect profiles may not be fully established yet.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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My cancer diagnosis is HNSCC, STS, or TNBC and my tumor is scheduled for surgery.
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I have at least one tumor that can be reached for treatment.
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I am able to get out of my bed or chair and move around.
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I am a woman who is postmenopausal, surgically sterile, or agrees to use contraception.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am currently on treatment for an infection.
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I am currently pregnant, breastfeeding, or both.
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My tumor is too close to vital body parts, making treatment injections risky.
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My skin cancer is known to originate from the head or neck area.
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I do not have uncontrolled autoimmune diseases, HIV/AIDS, or active hepatitis B/C.
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I have had a transplant of an organ or tissue from another person.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1-2 days after microdose injection
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1-2 days after microdose injection for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Quantification of Cell Death and Immune Cell Biomarkers by immuno-histochemistry (IHC) and In-Situ Hybridization (ISH)
Secondary outcome measures
Number of Patients with Adverse Events

Trial Design

1Treatment groups
Experimental Treatment
Group I: PBA-0405Experimental Treatment1 Intervention
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-0405, 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.

Find a Location

Who is running the clinical trial?

Pure Biologics S.A.Lead Sponsor
Presage BiosciencesIndustry Sponsor
9 Previous Clinical Trials
98 Total Patients Enrolled
John WeinbergStudy DirectorPure Biologics
~7 spots leftby Mar 2025
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