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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 60 months (from enrollment)
Awards & highlights
RiLEY Trial Summary
This trial is looking at the rate of disease control of the combination of 9-ING-41 and retifanlimab plus gemcitabine/nab-paclitaxel in patients with pancreatic cancer without prior systemic therapy for advanced disease.
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.Check my eligibility
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.See study design
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.
RiLEY Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
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.
RiLEY Trial 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)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Disease Control Rate (DCR)
Secondary outcome measures
Adverse Events and Serious Adverse Events
Duration of response (DOR)
Overall Response Rate (ORR)
+2 moreRiLEY 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
Retifanlimab
Not yet FDA approved
Gemcitabine
FDA approved
Paclitaxel
FDA approved
9-ING-41
Not yet FDA approved
Find a Location
Who is running the clinical trial?
University of Kansas Medical CenterLead Sponsor
458 Previous Clinical Trials
169,056 Total Patients Enrolled
Anwaar SaeedLead Sponsor
2 Previous Clinical Trials
151 Total Patients Enrolled
Actuate Therapeutics Inc.Industry Sponsor
8 Previous Clinical Trials
540 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My brain cancer is stable, and I haven't needed new treatments for it in the last 28 days.I have had an organ or stem cell transplant.I have not had a heart attack in the last 3 months and my ECG is normal.My pancreatic cancer is advanced or has spread, and I haven't received systemic treatment for it.I do not have an immune deficiency or active autoimmune disease, nor do I take high doses of steroids.My liver tests are within the required limits.I have been treated with drugs targeting PD-1, PD-L1, or PD-L2 before.I have serious heart issues, including recent heart failure, angina, stroke, or arrhythmia needing treatment.I am not allergic to retifanlimab or its ingredients.I have cancer other than pancreatic cancer.I have not received a live vaccine in the last 28 days.I have taken antibiotics within the last week.I have not taken any experimental cancer drugs in the last 14 days or longer.I have at least one tumor that can be measured and has not been treated with radiation.I am fully active or restricted in physically strenuous activity but can do light work.My blood tests show enough white blood cells, hemoglobin, and platelets.I haven't had, nor am I planning to have, major surgery around the time of this study.I haven't had major radiation therapy in the last 6 months or minor radiation within a week before starting the study treatment.I have or had lung scarring or inflammation not caused by an infection.I have a type of pancreatic cancer.I am allergic to certain cancer drugs or their ingredients.I have stored tumor samples available for the study.I had my last radiation or surgery at least a week ago.I have recovered from previous cancer treatment side effects, except for hair loss, mild anemia, or infertility.My kidneys work well, with a creatinine clearance rate over 60 mL/min.
Research Study Groups:
This trial has the following groups:- Group 1: 9-ING-41 plus Retifanlimab plus Gem/Abraxane
Awards:
This trial has 2 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are researchers looking for more participants in this clinical trial?
"This research project, which was first advertised on January 26th 2022 according to clinicaltrials.gov, is not currently looking for new participants. 806 other trials are still recruiting patients."
Answered by AI
What is the government's official stance on 9-ING-41?
"The safety of 9-ING-41 is estimated to be a 2. While there have been Phase 2 trials conducted which support the safety of the drug, there is no data currently available regarding its efficacy."
Answered by AI
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