What is the mechanism of action of this treatment?

Common treatments for pancreatic cancer often target the tumor's blood supply or directly attack cancer cells to inhibit growth. For example, therapies like ProAgio aim to disrupt the tumor vasculature, cutting off the blood supply that tumors need to grow and spread. Other treatments may involve chemotherapeutic agents that damage the DNA of cancer cells, leading to cell death. These mechanisms are crucial for pancreatic cancer patients because they address the aggressive nature of the disease, potentially slowing its progression and improving survival rates.

What side effects are associated with this type of intervention?

Common treatments for pancreatic cancer, such as gemcitabine combined with nab-paclitaxel, often result in side effects including neutropenia, fatigue, neuropathy, and diarrhea. Specifically, gemcitabine plus nab-paclitaxel has been associated with grade 3 or 4 toxicities like neutropenia (49%), fatigue (27%), and neuropathy (20%). These treatments aim to inhibit tumor growth by targeting tumor cells and vasculature, similar to the mechanism of action proposed for ProAgio.

What prior FDA approvals exist?

FDA-approved treatments for pancreatic cancer that target tumor vasculature or cells include FOLFIRINOX and gemcitabine-based regimens. FOLFIRINOX is a combination of oxaliplatin, irinotecan, leucovorin, and fluorouracil, which works by inhibiting cancer cell growth and division. Gemcitabine, often combined with nab-paclitaxel, disrupts the microtubule network essential for cell division, thereby inhibiting tumor growth. These treatments aim to reduce tumor size and improve survival rates in patients with pancreatic cancer.

What other types of research exist?

Promising novel alternatives to ProAgio for pancreatic cancer patients include: <ol> <li>Immune checkpoint inhibitors such as PD-1/PD-L1 inhibitors (e.g., pembrolizumab, nivolumab) which have shown efficacy in various solid tumors.</li> <li>mTOR inhibitors like temsirolimus, which have demonstrated some promise in other cancers and may be applicable to pancreatic cancer.</li> <li></li> </ol> HIF inhibitors, which target hypoxia-inducible factors to disrupt tumor angiogenesis and growth. 4. Combination therapies involving angiogenesis inhibitors and chemotherapy, which are being actively explored in clinical trials.

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Peptidomimetic

ProAgio for Advanced Pancreatic Cancer

Phase 1

Recruiting

Led By Christine Alewine, MD, PhD

Research Sponsored by ProDa BioTech, LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Histologically or cytologically confirmed diagnosis of a solid tumor malignancy for which no curative therapy exists as confirmed by the NCI Laboratory of Pathology

ECOG performance status <2 (Karnofsky >60%)

Must not have

Diagnosis of primary malignant CNS tumor

Participants with active or uncontrolled infections

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 years

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

As this is an early-phase trial for ProAgio, specific side effects aren't listed but generally could include typical reactions to cancer drugs such as fatigue, nausea, risk of infection due to immune system impact; organ-specific inflammation; allergic reactions; and potential impacts on blood pressure or heart rhythm.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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

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I am older than 18 years.

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My blood pressure is under control, my heart's QT interval is normal, and my resting heart rate is between 45 and 100 bpm.

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My blood and organ functions are within the required ranges for the trial.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been diagnosed with a primary brain tumor.

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I do not have any active or uncontrolled infections.

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I had radiation therapy less than 14 days ago.

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I have not had minor surgery in the last 14 days or major surgery in the last 28 days.

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I have a chronic neurological disorder that affects my movement, vision, or causes seizures.

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I have not had a stroke, heart attack, or blood clot in the last 28 days.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Determine Recommended Phase 2 Dose (RP2D)

Secondary study objectives

Assess serum tumor marker CA19-9 or appropriate tumor specific marker.

Disease control rate (DCR).

Evaluate the Maximum Plasma Concentration of ProAgio

+6 more

Other study objectives

Assess biologic effect of ProAgio on CAF and CASCs populations

Assess biologic effect of ProAgio on apoptosis of tumor cells in tumor tissue

Assess biologic effect of ProAgio on changes on Localization / populations of tumor cells

+11 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Group I: Standard ArmExperimental Treatment2 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 ArmExperimental Treatment1 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 EscalationExperimental Treatment3 Interventions

Participants will receive ProAgio in escalating doses.

0 / 11Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for pancreatic cancer often target the tumor's blood supply or directly attack cancer cells to inhibit growth. For example, therapies like ProAgio aim to disrupt the tumor vasculature, cutting off the blood supply that tumors need to grow and spread. Other treatments may involve chemotherapeutic agents that damage the DNA of cancer cells, leading to cell death. These mechanisms are crucial for pancreatic cancer patients because they address the aggressive nature of the disease, potentially slowing its progression and improving survival rates.

Prostaglandin E2 drives cyclooxygenase-2 expression via cyclic AMP response element activation in human pancreatic cancer cells.