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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
Approved for 10 Other Conditions
No Placebo-Only Group

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 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

Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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

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.

Find a Location

Who is running the clinical trial?

University of Kansas Medical CenterLead Sponsor
510 Previous Clinical Trials
176,851 Total Patients Enrolled
Anwaar SaeedLead Sponsor
3 Previous Clinical Trials
191 Total Patients Enrolled
Actuate Therapeutics Inc.Industry Sponsor
8 Previous Clinical Trials
540 Total Patients Enrolled

Media Library

9-ING-41 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05239182 — Phase 2
Pancreatic Adenocarcinoma Research Study Groups: 9-ING-41 plus Retifanlimab plus Gem/Abraxane
Pancreatic Adenocarcinoma Clinical Trial 2023: 9-ING-41 Highlights & Side Effects. Trial Name: NCT05239182 — Phase 2
9-ING-41 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05239182 — Phase 2
~0 spots leftby Dec 2024