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New treatment option for Pancreatic Adenocarcinoma
Official title 9-ING-41 Combined With Retifanlimab, Plus Modified FOLFIRINOX for Patients With Advanced Pancreatic Adenocarcinoma (RiLEY)
ClinicalTrials.gov ID: NCT06896188
What this study is testing
What is Retifanlimab?
Retifanlimab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for pancreatic adenocarcinoma.
Also referred to as ZYNYZ.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- Time commitment: about 2 years
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Is able to understand and voluntarily sign a written informed consent and is willing and able to comply with the protocol requirements including...
- Is aged ≥ 18 years.
- Has pathologically confirmed advanced, recurrent, or metastatic pancreatic cancer AND is previously untreated with systemic agents in the...
- Must have at least 1 measurable lesion per RECIST v1.1. Lesions that are radiated should not count as target lesions unless there is evidence of...
- Must have available archived FFPE tumor tissue at study entry; FFPE tissue block preferred or 10 unstained slides (metastatic tissue preferred to...
You likely can't join if
- Is pregnant or lactating.
- Is known to be hypersensitive to any of the components or metabolites of 9-ING-41 or to the excipients used in its formulation, or known sensitivity...
- History of receiving prior treatment with any anti-PD-1, PD-L1 or PD-L2 agent.
- Has endocrine or acinar pancreatic carcinoma.
- Has not recovered from clinically significant toxicities as a result of prior anticancer therapy, except alopecia, anemia not requiring transfusion...
- Has significant cardiovascular impairment: history of congestive heart failure greater than New York Heart Association (NYHA) Class II, unstable...
See the full eligibility criteria
Who can join
- Is able to understand and voluntarily sign a written informed consent and is willing and able to comply with the protocol requirements including scheduled visits, treatment plan, laboratory tests and other study...
- Is aged ≥ 18 years.
- Has pathologically confirmed advanced, recurrent, or metastatic pancreatic cancer AND is previously untreated with systemic agents in the advanced/metastatic setting.
- Must have at least 1 measurable lesion per RECIST v1.1. Lesions that are radiated should not count as target lesions unless there is evidence of growth post radiation on a subsequent scan prior to trial enrollment.
- Must have available archived FFPE tumor tissue at study entry; FFPE tissue block preferred or 10 unstained slides (metastatic tissue preferred to primary tissue) OR if FFPE archived tissue is not available, willing to...
- Has laboratory function within specified parameters (may be repeated):
- Adequate bone marrow function: absolute neutrophil count (ANC) ≥ 1,500/mL; hemoglobin ≥ 8.5 g/dL, platelets ≥ 100,000/mL
- 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...
- Adequate renal function: CrCl \> 60 mL/min measured or calculated by Cockcroft-Gault (C-G) equation (estimated glomerular filtration rate [eGFR] can also be used in place of CrCl)
- Serum amylase and lipase ≤ 1.5 x ULN
- Eastern Co-operative Oncology Group (ECOG) performance status (PS) 0 - 1 (Appendix A)
- Has received the final dose of any of the following treatments/ procedures within the specified minimum intervals before first dose of study drug:
- Focal radiation therapy - 7 days
- Surgery with general anesthesia - 7 days
- Surgery with local anesthesia - 7 days
- May have received treatment with fluorouracil or gemcitabine as a radiation sensitizer in the adjuvant setting if the treatment was received at least 6 months before study enrollment.
- May have received neoadjuvant chemotherapy with FOLFIRINOX if given at least 6 months before study enrollment.
- May have received prior cytotoxic doses of systemic chemotherapy in the adjuvant setting if given at least 6 months before study enrollment.
- Women of childbearing potential must have a negative baseline blood or urine pregnancy test within 72 hours of first study therapy. Women may be neither breastfeeding nor intending to become pregnant during study...
- Male patients with partners of childbearing potential must take appropriate precautions to avoid fathering a child from screening until 9 months after discontinuation of study treatment and use appropriate barrier...
- Must not be receiving any other investigational medicinal product.
What rules you out
- Is pregnant or lactating.
- Is known to be hypersensitive to any of the components or metabolites of 9-ING-41 or to the excipients used in its formulation, or known sensitivity to one of the chemotherapeutic agents or to the PD-1 inhibitor.
- History of receiving prior treatment with any anti-PD-1, PD-L1 or PD-L2 agent.
- Has endocrine or acinar pancreatic carcinoma.
- Has not recovered from clinically significant toxicities as a result of prior anticancer therapy, except alopecia, anemia not requiring transfusion support and infertility. Recovery is defined as ≤ Grade 1 or baseline...
- Has significant cardiovascular impairment: history of congestive heart failure greater than New York Heart Association (NYHA) Class II, unstable angina, or stroke within 6 months of the first dose of 9-ING-41, or...
- 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 treating investigator or PI.
- Has symptomatic rapidly progressive brain metastases or leptomeningeal involvement as assessed by computed tomography (CT) scan or magnetic resonance imaging (MRI). Patients with stable brain metastases or...
- Has had major surgery (not including placement of central lines) within 7 days prior to study entry or is planned to have major surgery during the course of the study (major surgery may be defined as any invasive...
- Has any medical and/or social condition that, in the opinion of the investigator would preclude study participation.
- Has received an investigational anti-cancer drug in the 14-day period before the first dose of study drug (or within 5 half-lives if longer) or is currently participating in another treatment clinical trial.
- Has a current malignancy other than pancreatic cancer.
- Known immunodeficiency syndrome or active autoimmune disease or requiring systemic immunosuppression in excess of physiologic maintenance doses of corticosteroids (\> 10 mg/day of prednisone or equivalent).
- Physiologic corticosteroid replacement therapy at doses \> 10 mg/day of prednisone or equivalent for adrenal or pituitary insufficiency and in the absence of active autoimmune disease is permitted.
- Participants with asthma that requires intermittent use of bronchodilators, inhaled steroids, or local steroid injections may participate.
- Participants using topical, ocular, intra-articular, or intranasal steroids (with minimal systemic absorption) may participate.
- Brief courses of corticosteroids for prophylaxis (eg, contrast dye allergy) or study treatment-related standard premedication are permitted.
- Evidence of interstitial lung disease, history of interstitial lung disease, or active, noninfectious pneumonitis.
- Palliative radiation therapy administered within 1 week of first dose of study treatment or radiation therapy that is \> 30 Gy within 6 months of the first dose of study treatment. Note: Participants must have recovered...
- Has received systemic antibiotics ≤ 7 days prior to the first dose of study drug.
- History of organ transplant, including allogeneic stem cell transplantation.
- Known hypersensitivity to another monoclonal antibody that cannot be controlled with standard measures (eg, antihistamines and corticosteroids).
- Known allergy or hypersensitivity to any component of retifanlimab or formulation components.
- Has received a live vaccine within 28 days of the planned start of study drug.
- Patients with known history of UGT1A1 gene polymorphism.
The study team makes the final eligibility decision.
Where it's taking place
- Pittsburgh, Pennsylvania, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 2 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Pittsburgh, Pennsylvania, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.