ProAgio for Advanced Pancreatic Cancer

Overseen By Zhi-Ren Liu

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: ProDa BioTech, LLC

Must not be taking: Steroids, Anticonvulsants

Disqualifiers: CNS tumors, Uncontrolled diseases, Pregnancy, others

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

Compensation: Varies

Number of Visits: Unknown

58 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests a new drug called ProAgio for safety and effectiveness in patients with advanced pancreatic cancer. Pancreatic cancer is very deadly, and current treatments are not very effective. ProAgio has shown good results in animal studies by treating the cancer and helping animals live longer.

Do I need to stop my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, you must be more than 14 days removed from your most recent standard or experimental drug treatment for your tumor.

What makes the drug ProAgio unique for treating advanced pancreatic cancer?

ProAgio is unique because it represents a novel approach in treating advanced pancreatic cancer, which has limited effective treatments and a high mortality rate. While traditional treatments focus on chemotherapy and surgery, ProAgio may offer a new mechanism of action or target, potentially improving outcomes for patients with this aggressive disease. ^{1 2 3 4 5}

Research Team

Christine Alewine, MD, PhD

Principal Investigator

National Cancer Institute (NCI)

Eligibility Criteria

This trial is for adults over 18 with advanced solid tumors, including pancreatic cancer, who've had at least one prior treatment. They must have a tumor that can be biopsied or measurable disease and good organ function. Participants need to use contraception and cannot join if they're pregnant, have significant uncontrolled diseases, active infections, recent surgery or radiation therapy, untreated brain metastases, certain blood pressure or heart rate conditions.

Inclusion Criteria

My cancer is confirmed and cannot be cured, according to a pathology lab.

Ability of subject to understand and the willingness to sign a written informed consent document

I can take care of myself but may not be able to do heavy physical work.

Exclusion Criteria

I have been diagnosed with a primary brain tumor.

I do not have any active or uncontrolled infections.

I have not had uncontrolled bleeding in the last 28 days.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants will receive ProAgio in escalating doses to determine the maximum tolerated dose (MTD)

Variable, until MTD is determined

Expansion Cohort

Participants with advanced nonendocrine pancreatic adenocarcinoma will receive ProAgio at the MTD, with optional co-administration of gemcitabine

Until disease progression or unacceptable toxicity

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 years

Treatment Details

Interventions

• ProAgio

Trial Overview The study tests the safety of different dose levels of ProAgio in patients with various advanced solid tumors. It's a first-in-human Phase I trial where participants are given escalating doses to find out how much of this new drug can be safely administered.

Participant Groups

Group I: Standard Arm Experimental Treatment 2 Interventions

Participants will receive ProAgio at the RP2D and may elect to receive concurrent gemcitabine beginning with the start of Cycle 2.

Group II: Expansion Biopsy Arm Experimental Treatment 1 Intervention

Pre- and post-treatment tumor biopsy is optional for participants enrolled in the standard arm, but mandatory for participants enrolled in the biopsy arm.

Group III: Dose Escalation Experimental Treatment 3 Interventions

Participants will receive ProAgio in escalating doses.

Who Is Running the Clinical Trial?

ProDa BioTech, LLC

Lead Sponsor

Trials

3

Recruited

140+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Findings from Research

The introduction of multidisciplinary team (MDT) meetings has not significantly changed the management of pancreatic body carcinoma, but there is a noted increase in the prevalence of more advanced disease at diagnosis, with 65.2% of patients diagnosed post-MDT presenting with stage IV tumors.

Chemotherapy was found to provide a significant survival benefit for patients, with a hazard ratio of 0.39, indicating that those receiving chemotherapy had a lower risk of death compared to those who did not, despite no overall increase in survival rates after the introduction of MDT meetings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Carcinoma of the body of pancreas in evolution: an aggressive disease affecting younger patients? Dickinson, KJ., Gomez, D., Lowe, A., et al.[2007]

In a study of 126 patients who underwent radical pancreatic surgery, those with adenocarcinoma had significantly worse survival rates compared to other types of tumors, highlighting the aggressive nature of this cancer.

Key factors affecting survival included tumor differentiation and nodal status, with a positive resection margin (R1) also linked to poorer outcomes, indicating the importance of complete tumor removal for better prognosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of surgery for pancreatic cancer: a 12-year review of patient outcome. Badger, SA., Brant, JL., Jones, C., et al.[2021]

Combined modality treatment for locally advanced pancreatic cancer, which includes both local and systemic therapies, shows better outcomes than using irradiation alone or just providing symptomatic treatment.

The prognosis for patients with this type of cancer remains poor, with median survival still only 3-5 months, highlighting the need for effective treatment strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multimodality treatment of locally advanced pancreatic cancer. Wagener, DJ., de Mulder, PH., Wils, JA.[2019]

Over 80% of pancreatic cancer cases are diagnosed at an advanced stage, whether localized, locally advanced, or metastatic, leading to poor outcomes.

Despite advancements in cancer treatment and molecular analysis over the past 20 years, the mortality rate for advanced pancreatic cancer remains largely unchanged, highlighting the need for improved therapeutic strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advanced pancreatic cancer: The standard of care and new opportunities. Mohammad, AA.[2020]

Over the past 12 years, outcomes for patients with advanced pancreatic cancer have improved significantly due to advancements in systemic therapies, including new strategies like switch maintenance and targeted agents for specific genetic variants.

While immunotherapy has not yet shown strong results in treating advanced pancreatic cancer, ongoing research into novel combinations and better patient selection may enhance its effectiveness in the future.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advancements in Systemic Therapy for Pancreatic Cancer. Brown, TJ., Reiss, KA., O'Hara, MH.[2023]

References

1. Italy pubmed.ncbi.nlm.nih.gov

Carcinoma of the body of pancreas in evolution: an aggressive disease affecting younger patients? [2007]

2. Northern Ireland pubmed.ncbi.nlm.nih.gov

The role of surgery for pancreatic cancer: a 12-year review of patient outcome. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Multimodality treatment of locally advanced pancreatic cancer. [2019]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Advanced pancreatic cancer: The standard of care and new opportunities. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

Advancements in Systemic Therapy for Pancreatic Cancer. [2023]