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

Palo Alto (17 mi)

Anwaar Saeed - Chief, Gastrointestinal ...

Overseen byAnwaar Saeed

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: University of Kansas Medical Center

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

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.

Inclusion Criteria

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

My liver tests are within the required limits.

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.

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

Exclusion Criteria

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.

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

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

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

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

Treatment Details

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.

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.)