PBA-0111 for Breast Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores how a new treatment, PBA-0111, affects breast cancer when administered directly into the tumor in small amounts. The goal is to understand the biological changes in the tumor environment before surgery. Participants should have breast cancer scheduled for surgical removal and a tumor suitable for direct injection with the treatment. The trial aims to learn more about PBA-0111's potential to affect cancer at the cellular level. As an Early Phase 1 trial, participants will be among the first to receive this treatment, aiding researchers in understanding its effects in people.
Do I need to stop taking my current medications to join the trial?
The trial requires that you stop taking certain medications, such as systemic anti-cancer therapy, immunosuppressive drugs, and systemic glucocorticoids, at least 3 weeks before the injection. However, some medications like low-dose corticosteroids for specific conditions are allowed. It's best to discuss your current medications with the trial team to see if any adjustments are needed.
What prior data suggests that the CIVO device is safe for delivering PBA-0111?
Research shows that PBA-0111 is being tested for its safety and effects on breast cancer. The treatment is administered in small amounts directly into the tumor. Earlier studies have not found major safety issues with this method. However, since it remains in the early testing phase, researchers are still learning about all possible side effects. Early-stage trials primarily focus on ensuring the treatment's safety for patients. While some unknowns may exist, the main goal is to determine if the treatment is safe for use.12345
Why do researchers think this study treatment might be promising?
Researchers are excited about PBA-0111 for breast cancer because it introduces a novel delivery method using the CIVO device. Unlike traditional systemic treatments like chemotherapy, which affect the entire body, PBA-0111 is delivered directly into the tumor in microdoses. This localized approach allows researchers to observe the drug’s effect on the tumor cells without the broader side effects typically associated with systemic treatments. Additionally, this method provides real-time insights into how the tumor responds to treatment, potentially accelerating the development of more effective and personalized cancer therapies.
What evidence suggests that PBA-0111 might be an effective treatment for breast cancer?
Research has shown that PBA-0111 fights cancer by targeting and removing specific cells that weaken the immune system within tumors. In studies with mice that have tumors similar to those in humans, PBA-0111 reduced tumor growth. This treatment is a special type of protein called an antibody, which attaches to specific cells and attacks cancer cells in two ways. Although limited information exists from human studies, early results suggest that PBA-0111 might positively affect the tumor environment. More research is needed to confirm its effectiveness in people.26789
Who Is on the Research Team?
John Weinberg, MBBCH
Principal Investigator
Pure Biologics
Are You a Good Fit for This Trial?
This trial is for individuals with certain solid tumors, including squamous cell carcinoma, breast cancer, and soft tissue sarcoma. Specific eligibility criteria are not provided here, but typically participants would need a confirmed diagnosis and meet other health requirements set by the study.Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Intratumoral microdose administration of PBA-0111 using the CIVO device
Surgical Intervention
Surgical biopsy or tumor resection surgery to assess tumor response
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- PBA-0111
Trial Overview
The trial is testing PBA-0111's effects on tumor biology when given in tiny amounts directly into the tumor using a device called CIVO. It's an early-stage (Phase 0) study to see how the drug works within the tumor environment.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
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
Find a Clinic Near You
Who Is Running the Clinical Trial?
Pure Biologics S.A.
Lead Sponsor
Citations
NCT06700070 | A Phase 0 Multicenter Study of the ...
A Phase 0 Multicenter Study of the Pharmacodynamic Effects of Intratumoral Microdose Administration of PBA-0111 in Patients With Solid Tumors. ClinicalTrials.
PBA-0111 for Breast Cancer
This Phase < 1 medical study run by Pure Biologics S.A. is evaluating whether PBA-0111 will have tolerable side effects & efficacy for patients with Breast ...
PBA-0111 - Drug Targets, Indications, Patents
PBA-0111 (PB003G) is a dual-action therapeutic antibody that simultaneously eliminates immunosuppressive regulatory T (Treg) cells in the tumor ...
4.
purebiologics.com
purebiologics.com/news/eind-submission-for-the-pb004-project-and-further-development-of-pb003g-towards-phase-0/eIND submission for the PB004 project and further ...
The in vitro and in vivo results of candidates PBA-0405 and PBA-0111 in the PB004 and PB003G projects make us optimistic. The molecule ...
5.
linkedin.com
linkedin.com/posts/pieter-spee-3b89665_cancer-immunotherapy-innovation-activity-7219347804224159744-RIVqPieter Spee's Post
Studies performed in tumor-bearing humanized mice suggest that PBA-0111 holds great promise for solid tumor #treatment. The Phase 0 clinical ...
6.
breastcancertrials.org
breastcancertrials.org/bct_nation/mts/mtsResult.seam?zip=94107&searchTerm1=NCT06700070MTS Trials - BreastCancerTrials.org
Purpose: To study the safety, effects (good and bad), and anti-cancer activity of PBA-0111 immunotherapy. Who is this for?:
PB003G - Harnessing the power of antibodies and aptamers
The study will investigate early signs of anticancer activity of PBA-0111 in a complex human tumour environment. The study is expected to be completed by the ...
Nanomaterials: breaking the bottleneck of breast cancer ...
The safety data indicated that the safety profile of the pertuzumab treatment group aligned with known expectations, with no significant ...
Injectable immunogel based on polymerized ...
We developed a polymerized phenylboronic acid (pPBA)-based immunogel for the simultaneous delivery of mannan, which has adjuvanticity and tumor antigen.
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