Actively Recruiting
9-ING-41 Combined With Retifanlimab, Plus Modified FOLFIRINOX for Patients With Advanced Pancreatic Adenocarcinoma (RiLEY)
Led by Anwaar Saeed · Updated on 2025-09-29
12
Participants Needed
1
Research Sites
170 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
This is a study of the combination of 9 ING-41 (elraglusib) and retifanlimab plus mFOLFIRINOX in patients with pancreatic cancer without prior systemic therapy for advanced disease. The safety lead-in cohort will consist of 6 patients, followed by dose de-escalation if necessary, based on safety assessments. After evaluating the safety and tolerability at the initial dose level, the study will proceed to an expansion cohort at the determined safe dose level, with the total maximum enrollment not exceeding 12 patients for the entire study.
CONDITIONS
Official 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 procedures
- Aged 18 years or older
- Diagnosed with advanced, recurrent, or metastatic pancreatic cancer without prior systemic therapy for advanced disease
- Has at least 1 measurable lesion by RECIST v1.1 criteria
- Has archived formalin-fixed paraffin-embedded (FFPE) tumor tissue available or willing to provide fresh biopsy for molecular profiling
- Adequate bone marrow function: ANC ≥ 1,500/mL; hemoglobin ≥ 8.5 g/dL; platelets ≥ 100,000/mL
- Adequate liver function: AST/ALT and alkaline phosphatase ≤ 2.5 x upper limit of normal (ULN), or ≤ 5 x ULN if liver metastases present; bilirubin ≤ 1.5 x ULN
- Adequate kidney function with creatinine clearance > 60 mL/min or estimated glomerular filtration rate
- Serum amylase and lipase ≤ 1.5 x ULN
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Completed focal radiation therapy, surgery, or chemotherapy with required minimum time intervals before starting study treatment
- Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception during and 9 months after study participation
- Male patients with partners of childbearing potential must use contraception or abstain during and 9 months after study participation
- Not receiving any other investigational drug
You will not qualify if you...
- Pregnant or breastfeeding
- Known allergy or hypersensitivity to 9-ING-41, retifanlimab, chemotherapy agents, or their components
- Prior treatment with anti-PD-1, PD-L1, or PD-L2 therapies
- Diagnosis of endocrine or acinar pancreatic carcinoma
- Not recovered from significant toxicities from previous cancer treatments except mild alopecia, anemia, or infertility
- Significant heart conditions including congestive heart failure NYHA class > II, unstable angina, recent stroke, or arrhythmias requiring treatment
- Recent myocardial infarction or relevant ECG abnormalities
- Rapidly progressing brain metastases or leptomeningeal disease
- Major surgery within 7 days before study entry or planned major surgery during the study
- Medical or social conditions that would interfere with study participation
- Participation in another interventional clinical trial or investigational drug within 14 days before study
- Current malignancy other than pancreatic cancer
- Known immunodeficiency, active autoimmune disease requiring high-dose immunosuppression
- Interstitial lung disease or active noninfectious pneumonitis
- Recent palliative radiation therapy or high-dose radiation within 6 months
- Recent systemic antibiotics within 7 days before study drug
- History of organ transplant
- Received live vaccine within 28 days before study drug
- Known UGT1A1 gene polymorphism
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States, 15232
Actively Recruiting
Research Team
D
Debra Diecks, BSN
CONTACT
A
Amy Rose, BSN
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here