58 Participants Needed

ProAgio for Advanced Pancreatic Cancer

DR
ZL
Overseen ByZhi-Ren Liu
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

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.12345

Who Is on the Research Team?

CA

Christine Alewine, MD, PhD

Principal Investigator

National Cancer Institute (NCI)

Are You a Good Fit for This Trial?

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.
See 9 more

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.
See 11 more

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
3Treatment groups
Experimental Treatment
Group I: Standard ArmExperimental Treatment2 Interventions
Group II: Expansion Biopsy ArmExperimental Treatment1 Intervention
Group III: Dose EscalationExperimental Treatment3 Interventions

Find a Clinic Near You

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+

Published Research Related to This Trial

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

Citations

Carcinoma of the body of pancreas in evolution: an aggressive disease affecting younger patients? [2007]
2.Northern Irelandpubmed.ncbi.nlm.nih.gov
The role of surgery for pancreatic cancer: a 12-year review of patient outcome. [2021]
Multimodality treatment of locally advanced pancreatic cancer. [2019]
Advanced pancreatic cancer: The standard of care and new opportunities. [2020]
Advancements in Systemic Therapy for Pancreatic Cancer. [2023]
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