Actively Recruiting
9-ING-41 (Elraglusib) Combined With Retifanlimab and Modified FOLFIRINOX as Frontline Therapy for Advanced Pancreatic Adenocarcinoma (RiLEY)
Led by Anwaar Saeed · Updated on 2025-09-29
12
Participants Needed
1
Research Sites
65 weeks
Total Duration
On this page
Sponsors
A
Anwaar Saeed
Lead Sponsor
A
Actuate Therapeutics Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying a combination treatment involving 9-ING-41 (elraglusib), retifanlimab, and modified FOLFIRINOX chemotherapy in patients with advanced pancreatic adenocarcinoma who have not received prior systemic therapy for their advanced disease. This Phase 1b study aims to evaluate the safety, tolerability, and potential anti-tumor activity of these combined therapies, as 9-ING-41 inhibits GSK-3β which may enhance immune response when combined with a PD-1 inhibitor like retifanlimab. The study builds on previous positive safety and efficacy data for each agent separately but seeks to understand their combined effects. The treatment involves chemotherapy with oxaliplatin, leucovorin, irinotecan, and 5-FU administered every 14 days, retifanlimab given by IV infusion at 500 mg on day 1 of every other cycle, and 9-ING-41 given intravenously twice weekly for the first four cycles then weekly thereafter. The study starts with a safety lead-in cohort of 6 patients to assess dose-limiting toxicities and may adjust doses accordingly before expanding to a larger group up to 12 patients total. This combination has not been previously tested together in humans. Participants will undergo scheduled visits with laboratory tests and imaging to monitor treatment safety and tumor response. Researchers will track dose-limiting toxicities within 28 days of treatment start and measure disease control rates, response rates, progression-free survival, overall survival, and treatment-related adverse events over months to years. The study includes detailed monitoring of lab function, performance status, and tumor measurements to assess outcomes and safety during follow-up periods up to 42 months.
CONDITIONS
Brief Title
9-ING-41 Combined With Retifanlimab, Plus Modified FOLFIRINOX for Patients With Advanced Pancreatic Adenocarcinoma (RiLEY)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to understand and voluntarily sign informed consent and comply with study requirements
- Age 18 years or older
- Pathologically confirmed advanced, recurrent, or metastatic pancreatic cancer not previously treated with systemic agents in advanced/metastatic setting
- At least 1 measurable lesion per RECIST v1.1 criteria
- Availability of archived tumor tissue or willingness to provide fresh biopsy for molecular profiling
- Adequate bone marrow, liver, kidney function, and serum amylase and lipase within specified limits
- ECOG performance status of 0 or 1
- Completed prior treatments (radiation, surgery, or chemotherapy) with specified minimum intervals before study treatment
- Women of childbearing potential must have negative pregnancy test and agree to use effective contraception
- Male patients with partners of childbearing potential must use appropriate contraception
- Not receiving other investigational medicinal products
You will not qualify if you...
- Pregnant or lactating
- Known hypersensitivity to study drugs or their components
- Prior treatment with anti-PD-1, PD-L1, or PD-L2 agents
- Endocrine or acinar pancreatic carcinoma
- Not recovered from prior therapy toxicities except certain exceptions
- Significant cardiovascular conditions or recent cardiac events
- Symptomatic rapidly progressive brain metastases or leptomeningeal involvement
- Recent major surgery or planned major surgery during study
- Medical or social conditions precluding participation
- Recent investigational anti-cancer drug use or participation in another interventional trial
- Current malignancy other than pancreatic cancer
- Known immunodeficiency or active autoimmune disease requiring high-dose immunosuppression
- Interstitial lung disease or active pneumonitis
- Recent radiation therapy with unresolved toxicities
- Recent systemic antibiotic use
- History of organ transplant
- Known hypersensitivity to monoclonal antibodies
- Recent live vaccine administration
- Known UGT1A1 gene polymorphism
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 years
Participants receive combination drug treatment with 9-ING-41, retifanlimab, and modified FOLFIRINOX chemotherapy as frontline therapy for advanced pancreatic adenocarcinoma.
Repeated treatment cycles every 14 days with retifanlimab given every other cycle and 9-ING-41 administered twice weekly for the first 4 cycles then weekly thereafter
Duration - Up to 42 months
Participants are monitored for disease control, progression, survival, and treatment-related adverse events after treatment ends.
Visits as scheduled for assessments up to 42 months after treatment
Trial Site Locations
Total: 1 location
1
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States, 15232
Actively Recruiting
Research Team
D
Debra Diecks, BSN
A
Amy Rose, BSN
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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