What is the mechanism of action of this treatment?

The treatment of Pancreatic Adenocarcinoma often involves targeting specific pathways to inhibit tumor growth and enhance the immune response. 9-ING-41 is a GSK-3 inhibitor that works by blocking the glycogen synthase kinase-3 enzyme, which is involved in various cellular processes including cell proliferation and survival. By inhibiting GSK-3, 9-ING-41 can reduce tumor growth and potentially enhance the effectiveness of other treatments. Retifanlimab is an anti-PD-1 monoclonal antibody that works by blocking the programmed cell death protein 1 (PD-1) pathway, which tumors often exploit to evade the immune system. By inhibiting PD-1, Retifanlimab can enhance the body's immune response against cancer cells. These mechanisms are crucial for Pancreatic Adenocarcinoma patients as they offer a multi-faceted approach to controlling tumor growth and improving the effectiveness of the immune system in targeting cancer cells.

What side effects are associated with this type of intervention?

Common treatments for Pancreatic Adenocarcinoma, such as gemcitabine and nab-paclitaxel, often result in side effects including nausea, fatigue, diarrhea, and hematologic toxicities like neutropenia and thrombocytopenia. The addition of 9-ING-41, a GSK-3 inhibitor, may introduce side effects such as gastrointestinal disturbances and potential liver enzyme elevations. Retifanlimab, an anti-PD-1 monoclonal antibody, can cause immune-related adverse events, including pneumonitis, colitis, hepatitis, endocrinopathies, and skin reactions. Combining these treatments aims to enhance efficacy but may also compound the risk of these side effects.

What prior FDA approvals exist?

The FDA has approved several treatments for Pancreatic Adenocarcinoma, including chemotherapeutic agents like gemcitabine and nab-paclitaxel. In the realm of immunotherapy, pembrolizumab, an anti-PD-1 monoclonal antibody, has been approved for tumors with high microsatellite instability (MSI-H) or mismatch repair deficiency (dMMR). While there are no specific FDA approvals for GSK-3 inhibitors in this context, the ongoing trial of 9-ING-41 (a GSK-3 inhibitor) and Retifanlimab (an anti-PD-1 monoclonal antibody) aims to explore new therapeutic avenues by combining these novel agents with standard chemotherapy.

What other types of research exist?

A promising alternative for Pancreatic Adenocarcinoma patients could be the combination of gemcitabine with a dual tyrosine kinase inhibitor like AEE788, which targets EGFR and VEGFR. This combination has shown efficacy in preclinical models by decreasing phosphorylation of EGFR and VEGFR, potentially improving treatment outcomes.

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9-ING-41 + Immunotherapy + Chemotherapy for Pancreatic Cancer (RiLEY Trial)

Phase 2

Waitlist Available

Led By Anwaar Saeed, MD

Research Sponsored by University of Kansas Medical Center

Eligibility Criteria Checklist

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

Must have

Has pathologically confirmed advanced, recurrent, or metastatic pancreatic cancer AND is previously untreated with systemic agents in the advanced/metastatic setting

Adequate liver function: transaminases (aspartate aminotransferase/ alanine aminotransferase, AST/ALT) and alkaline phosphatase ≤ 2.5 x ULN (≤ 5 X the upper limit of normal (ULN) in the setting of liver metastasis or infiltration with malignant cells); bilirubin ≤ 1.5 x ULN

Must not have

History of organ transplant, including allogeneic stem cell transplantation

Has had a myocardial infarction within 12 weeks of the first dose of 9-ING-41 or has electrocardiogram (ECG) abnormalities that are deemed medically relevant by the investigator or study medical coordinator

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 60 months (from enrollment)

Awards & highlights

No Placebo-Only Group

Approved for 10 Other Conditions

Summary

This trial is testing a new treatment that adds two drugs to standard chemotherapy for advanced pancreatic cancer. The new drugs aim to help the immune system fight cancer more effectively. This treatment is for patients with a severe form of pancreatic cancer that may not respond well to standard treatments alone.

Who is the study for?

This trial is for adults with advanced, untreated pancreatic cancer who can consent to study procedures. They must have measurable disease, good liver and kidney function, no major surgery or certain treatments within specific time frames before the trial, and a performance status indicating they are relatively active.

What is being tested?

The study tests if adding 9-ING-41 and retifanlimab to standard chemotherapy (Gemcitabine/Nab-Paclitaxel) improves outcomes in pancreatic cancer patients. It aims to see if this combination affects how long patients live without their disease getting worse.

What are the potential side effects?

Potential side effects include reactions related to the immune system due to retifanlimab (like inflammation), typical chemotherapy side effects such as nausea, fatigue, low blood counts from Gemcitabine/Nab-Paclitaxel, and any unknown risks from the experimental drug 9-ING-41.

Eligibility Criteria

Inclusion Criteria

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

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My pancreatic cancer is advanced or has spread, and I haven't received systemic treatment for it.

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My liver tests are within the required limits.

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I have at least one tumor that can be measured and has not been treated with radiation.

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I am fully active or restricted in physically strenuous activity but can do light work.

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My blood tests show enough white blood cells, hemoglobin, and platelets.

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My kidneys work well, with a creatinine clearance rate over 60 mL/min.

Exclusion Criteria

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

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I have had an organ or stem cell transplant.

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I have not had a heart attack in the last 3 months and my ECG is normal.

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I do not have an immune deficiency or active autoimmune disease, nor do I take high doses of steroids.

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I have been treated with drugs targeting PD-1, PD-L1, or PD-L2 before.

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I am not allergic to retifanlimab or its ingredients.

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I have cancer other than pancreatic cancer.

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I have not received a live vaccine in the last 28 days.

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I have not taken any experimental cancer drugs in the last 14 days or longer.

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I haven't had, nor am I planning to have, major surgery around the time of this study.

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I haven't had major radiation therapy in the last 6 months or minor radiation within a week before starting the study treatment.

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I have or had lung scarring or inflammation not caused by an infection.

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I have a type of pancreatic cancer.

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I am allergic to certain cancer drugs or their ingredients.

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I have recovered from previous cancer treatment side effects, except for hair loss, mild anemia, or infertility.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 60 months (from enrollment)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 60 months (from enrollment)

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 60 months (from enrollment) for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Disease Control Rate (DCR)

Secondary study objectives

Adverse Events and Serious Adverse Events

Duration of response (DOR)

Overall Response Rate (ORR)

+2 more

Awards & Highlights

No Placebo-Only Group

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

Approved for 10 Other Conditions

This treatment demonstrated efficacy for 10 other conditions.

Trial Design

1Treatment groups

Experimental Treatment

Group I: 9-ING-41 plus Retifanlimab plus Gem/AbraxaneExperimental Treatment4 Interventions

* intravenous (IV) infusion of nab-paclitaxel at a dose of 125 mg per square meter, followed by an infusion of gemcitabine according to the gemcitabine label at a dose of 1000 mg per square meter, on days 1, 8, 15 of a 28-day cycle. * Retifanlimab 500 mg IV on day 1 of a 28-day cycle. (Retifanlimab will be administered following gemcitabine/nab-paclitaxel.) * 9-ING-41 administered at a dose of 9.3 mg/kg by IV infusion twice weekly on Days 1 and 4 of each week of a 28-day cycle. (9-ING-41 will be administered following retifanlimab.)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Gemcitabine

FDA approved

Paclitaxel

FDA approved

Retifanlimab

Not yet FDA approved

9-ING-41

Not yet FDA approved

0 / 20Eligibility 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

The treatment of Pancreatic Adenocarcinoma often involves targeting specific pathways to inhibit tumor growth and enhance the immune response. 9-ING-41 is a GSK-3 inhibitor that works by blocking the glycogen synthase kinase-3 enzyme, which is involved in various cellular processes including cell proliferation and survival. By inhibiting GSK-3, 9-ING-41 can reduce tumor growth and potentially enhance the effectiveness of other treatments. Retifanlimab is an anti-PD-1 monoclonal antibody that works by blocking the programmed cell death protein 1 (PD-1) pathway, which tumors often exploit to evade the immune system. By inhibiting PD-1, Retifanlimab can enhance the body's immune response against cancer cells. These mechanisms are crucial for Pancreatic Adenocarcinoma patients as they offer a multi-faceted approach to controlling tumor growth and improving the effectiveness of the immune system in targeting cancer cells.