PCX-12 + Radiotherapy for Pancreatic Cancer

Overseen By Haoming Qiu

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Haoming (Carl) Qiu

Disqualifiers: Metastatic disease, Prior radiation, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 2 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment for pancreatic cancer that combines radiation therapy with an experimental drug called PCX-12. The goal is to determine if this combination is safe and tolerable for patients. PCX-12 is injected into the cancer to help the immune system fight it. Individuals with pancreatic cancer that remains inoperable after chemotherapy might be suitable candidates. The cancer should still be visible on a CT scan and should not have spread to other organs. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new therapy.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that PCX-12, a new treatment that aids the immune system, is under study to assess its safety and tolerability. Similar treatments, such as PX-12, have been safely administered to patients through a controlled process in the past. These treatments were tested to understand their effects in the body and potential side effects.

In earlier studies with PX-12, most patients tolerated the treatment well, though some experienced mild to moderate side effects like nausea and fatigue, common with many cancer treatments. Since PCX-12 is still in early testing stages, researchers are primarily focused on ensuring its safety. They are closely monitoring and recording any side effects or reactions during the current studies.

For those considering participation, it's important to know that early-phase trials like this one prioritize safety to ensure the treatment is suitable for patients. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for pancreatic cancer?

Unlike the standard treatments for pancreatic cancer, which often include chemotherapy and radiation, PCX-12 offers a novel approach by stimulating the immune system directly. This experimental immunotherapy is injected straight into the tumor, aiming to activate the body's natural defenses to target and destroy cancer cells. Researchers are excited about PCX-12 because it represents a shift from traditional methods, potentially offering a more targeted and less invasive treatment option. This could lead to more effective outcomes with fewer side effects compared to conventional therapies.

What evidence suggests that this treatment might be an effective treatment for pancreatic cancer?

Research shows that PCX-12, a new treatment that boosts the immune system, might help fight pancreatic cancer. In this trial, participants will receive PCX-12 alongside radiation therapy. Early results suggest that this combination could improve patient response to treatment and extend survival. The combination aims to enhance the immune system's ability to attack cancer cells. Similar treatments have shown success with other cancer types, but further research is needed to determine its effectiveness for pancreatic cancer specifically. ^{6 7 8 9 10}

Who Is on the Research Team?

Haoming Qiu

Principal Investigator

University of Rochester

Are You a Good Fit for This Trial?

This trial is for individuals with locally advanced pancreatic adenocarcinoma. Specific eligibility details are not provided, but typically participants should meet certain health standards and may be required to have a particular stage of cancer.

Inclusion Criteria

Anticipated life expectancy ≥ 12 weeks

I can take care of myself and perform daily activities.

My pancreatic cancer is advanced but has not spread far.

Exclusion Criteria

I cannot undergo SBRT, endoscopic ultrasound, or IL-12 injections.

I have had cancer before.

My cancer has spread or worsened after initial treatment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation

Participants undergo standard of care radiation therapy

4 weeks

Treatment

Participants receive PCX12 immunotherapy with escalating doses from 200 ng/kg to 800 ng/kg

2 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 years

What Are the Treatments Tested in This Trial?

Interventions

• PCX-12

Trial Overview The study is testing the safety and tolerability of combining Stereotactic Body Radiotherapy (SBRT) with an immunotherapy drug called PCX12, administered directly into the tumor in patients with pancreatic cancer.

How Is the Trial Designed?

Group I: PCX-12 Experimental Treatment 1 Intervention

PCX-12 is an experimental immunotherapy drug that is injected into the pancreatic cancer one time in attempt to stimulate the patient's immune system to fight the cancer.

Who Is Running the Clinical Trial?

Haoming (Carl) Qiu

Lead Sponsor

Trials

1

Recruited

20+

Published Research Related to This Trial

Concurrent chemotherapy and radiotherapy for pancreatic adenocarcinoma can lead to predictable acute toxicities that vary based on the intensity of the treatment and the specifics of the radiotherapy, highlighting the importance of careful management.

Proactive planning and management of both surgical complications and treatment toxicities are crucial to prevent unplanned treatment interruptions and ensure patients can complete their therapy effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Supportive care considerations during concurrent chemoradiotherapy for pancreatic adenocarcinoma: lessons learned from clinical experience. Wang-Gillam, A., Abrams, RA., Posner, MC., et al.[2013]

In a meta-analysis of 830 patients with locally advanced unresectable pancreatic cancer, adding radiotherapy to chemotherapy did not improve overall survival or progression-free survival in randomized controlled trials, and it was associated with increased severe gastrointestinal adverse events.

Observational studies suggested a potential benefit of radiotherapy on survival outcomes, but these results may be influenced by differences in patient characteristics, highlighting the need for further research to identify which patients might truly benefit from radiotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chemoradiotherapy versus chemotherapy for locally advanced unresectable pancreatic cancer: A systematic review and meta-analysis. Ng, IW., Soon, YY., Chen, D., et al.[2019]

Proton radiotherapy offers a promising approach for treating pancreatic carcinoma by delivering high doses of radiation directly to tumors while minimizing damage to surrounding healthy organs, which can reduce treatment toxicity.

Combining proton radiotherapy with improved chemotherapy regimens is essential for enhancing local-regional control of pancreatic cancer, potentially leading to better overall patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Proton beam radiotherapy for pancreas cancer. Rutenberg, MS., Nichols, RC.[2020]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06217666

NCT06217666 | Study Examining the Safety and Toxicity of ... The purpose of this study is to determine whether a new treatment combining radiation therapy with PCX12 is safe and tolerable. Detailed Description. Single ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12195586/

A Systematic Review of Immunotherapy in Multimodal Treatment Improving outcomes in pancreatic adenocarcinoma: a systematic review of immunotherapy in multimodal treatment.

3. therapyxinc.com therapyxinc.com/exstam/

EXStaM We expect that using PCX12 along with SBRT will result in improved responses and increased survival rates for patients with pancreatic cancer, and perhaps other ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9856436/

Real World Data for Pancreatic Adenocarcinoma from a ... For the entire cohort, 1-year mortality rate after diagnosis was 77.81%. Chemotherapy was associated with better survival for both operated (HR ...

5. go.drugbank.com go.drugbank.com/conditions/DBCOND0031512

Pancreatic Adenocarcinoma (DBCOND0031512) ... PCX12 Immunotherapy Delivered by Intratumoral Injection for the Treatment of Patients With Locally Advanced Pancreatic Adenocarcinoma (LAPC). PCX-12.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06217666

NCT06217666 | Study Examining the Safety and Toxicity of ... The purpose of this study is to determine whether a new treatment combining radiation therapy with PCX12 is safe and tolerable. Detailed Description. Single ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3988981/

A phase IB trial of 24-hour intravenous PX-12, a Thioredoxin-1 ... We investigated the safety, pharmacokinetics, and pharmacodynamics of PX-12, a thioredoxin-1 (Trx-1) inhibitor, administered as a 24-hour infusion every 7 or ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT00417287?intr=PX-12&rank=1

Phase II Study of PX-12 in Patients With Advanced ... This study is being conducted to evaluate the clinical efficacy, biologic activity (inhibition of PX-12 target thioredoxin-1) and effects of an expired ...

9. trial.medpath.com trial.medpath.com/drug/17988a6a5f351b8c/pcx-12

PCX-12 - MedPath This report provides a comprehensive analysis of PCX12, an investigational therapeutic vaccine developed by the biotechnology company TherapyX, ...

10. synapse.patsnap.com synapse.patsnap.com/drug/80e868a9464e49c18c158938dc84934d

PCX-12 - Drug Targets, Indications, Patents A Phase 1, Prospective, Standard Dose Escalation Study Examining the Safety and Toxicity of Stereotactic Body Radiotherapy (SBRT) Followed by PCX12 ...