Pancreatic AdenocarcinomaPhase 1RiLEYNCT06896188
9-ING-41 Combined With Retifanlimab, Plus Modified FOLFIRINOX for Patients With Advanced Pancreatic Adenocarcinoma (RiLEY)
A Phase 1 study testing Retifanlimab, Chemotherapy and 9-ING-41 in people with Pancreatic Adenocarcinoma, run by Anwaar Saeed at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Adenocarcinoma
- What is being tested?
- Retifanlimab, Chemotherapy and 9-ING-41
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Sep 2025to 31 Dec 2029
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to 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 procedures.
- 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 provide a standard fresh tumor biopsy prior to start of study treatment for molecular profiling of the tumor using standard institutional oncomine panel. If oncomine testing has previously been completed, a repeat biopsy or testing is not required.
- Has laboratory function within specified parameters (may be repeated):
Show all 21Show fewer
- 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 infiltration with malignant cells); bilirubin ≤ 1.5 x ULN
- 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 participation and must agree to use effective contraceptive methods (hormonal AND barrier method of birth control, or true abstinence) for the duration of study participation and in the following 9 months after discontinuation of study treatment.
- 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 contraception or true abstinence.
- Must not be receiving any other investigational medicinal product.
Who cannot join
- 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 severity per Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 (v5.0).
- 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 cardiac arrhythmia requiring medical treatment detected at screening.
Show all 25Show fewer
- 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 leptomeningeal disease or slowly progressive disease are eligible provided that they have not required new treatments for this disease in a 28-day period before the first dose of study drug, and anticonvulsants and steroids are at a stable dose for a period of 14 days prior to the first dose of study drug.
- 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 operative procedure in which an extensive resection is performed, e.g., a body cavity is entered, organs are removed, or normal anatomy is altered). In general, if a mesenchymal barrier is opened (pleural cavity, peritoneum, meninges), the surgery is considered major.
- 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 interventional 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 from all radiation-related toxicities, not require corticosteroids for this purpose, and not have had radiation pneumonitis.
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232
Debra Diecks, BSN, 412-623-8364, diecksda@upmc.edu
Amy Rose, BSN, 412-647-8587, kennaj@upmc.edu
About this study
Official title: A Phase Ib Study of 9-ING-41 (Elraglusib), a Glycogen Synthase Kinase 3-beta (GSK-3β) Inhibitor, Combined With Retifanlimab, a PD-1 Inhibitor, Plus Modified FOLFIRINOX as Frontline Therapy for Patients With Advanced Pancreatic Adenocarcinoma (RiLEY)
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.
Read the detailed description
Given the role of GSK-3β in immune regulation, the combination of GSK-3β inhibition with PD 1 inhibition may be expected to provide synergistic anti-tumor efficacy. The excellent safety profile of 9-ING-41, along with preclinical and clinical evidence of anti-tumor activity in pancreatic cancer, provides a strong rationale to evaluate the efficacy of 9-ING-41 in combination with a PD 1 inhibitor plus standard chemotherapy (mFOLFIRINOX) as frontline therapy for patients with advanced PDAC. The PD-1 inhibitor to be used in the present study is retifanlimab, a humanized, hinge-stabilized immunoglobulin G4 (IgG4) monoclonal antibody. Retifanlimab has shown positive results for the treatment of patients with squamous carcinoma of the anal canal (SCAC) who have progressed after first-line chemotherapy treatment. In the Phase 2 PODIUM-202 trial, retifanlimab was well-tolerated at a dose of 500 mg administered via IV infusion every 4 weeks (28-day cycle) for up to 2 years.The combination of 9-ING-41 and retifanlimab with mFOLFIRINOX has not previously been administered to human subjects. In the 1801 study, 9-ING-41 has been administered in combination with various chemotherapy regimens including irinotecan,and has been well-tolerated. Retifanlimab alone has been well-tolerated when administered for up to 2 years in patients with anal cancer. Overall, based on previous nonclinical and clinical experience, both of these agents appear to have an acceptable safety profile and do not appear to have significant overlapping toxicities. However, it is possible that when they are administered together and in combination with mFOLFIRINOX, more frequent or severe AEs, or new AEs not previously observed with any of these agents administered alone, may occur. It is not known if administration of 9-ING-41 and retifanlimab will act synergistically to provide increased anti-tumor activity compared to mFOLFIRINOX alone. Subjects in this study should not expect to benefit directly by their participation in the study. The data collected in this study may benefit future cancer patients
- Conditions
- Pancreatic Adenocarcinoma
- Being tested
- Retifanlimab, Chemotherapy, 9-ING-41
- Keywords
- Glycogen Synthase Kinase 3-beta (GSK-3β) inhibitor, PD-1 inhibitor
- Medical subject headings
- Hereditary Sensory and Autonomic Neuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RetifanlimabDrug
Also called ZYNYZ
(PD-1)-blocking monoclonal antibody
ChemotherapyDrug
oxaliplatin - Antineoplastic - Platinum Complexes Chemotherapy agent; leucovorin - a form of Folic acid helps the body produce and maintain new cells, and also helps prevent changes to DNA that may lead to cancer; irinotecan - anti-cancer medication used to treat colon cancer in combination with other chemotherapeutic agents; 5-FU - 5-fluorouracil is used to treat cancer in combination with other chemotherapeutic agents
9-ING-41Drug
Also called Elraglusib
a maleimide-based ATP-competitive and selective glycogen synthase kinase-3β (GSK-3β) inhibitor with an IC50 of 0.71 μM. 9-ING-41 significantly leads to cell cycle arrest, autophagy and apoptosis in cancer cells
| Study group | Role | What they receive |
|---|---|---|
| Retifanlimab + 9-ING-41 + Chemotherapy | Experimental | 1. Chemotherapy: oxaliplatin 85 mg/m2 IV, leucovorin 400 mg/m2 IV, irinotecan 150 mg/m2 IV, and 5-FU continuous IV infusion 2400 mg/m2 over 46 hours every 14 days
2. Retifanlimab: IV at 500 mg on day 1 of every other cycle (Cycles 1, 3, 5, etc)
3.9-ING-41: IV at 9.3 mg/kg twice weekly (days 1, 3, 8 and 11) for the first 4 cycles, then weekly (days 1 and 8) thereafter Receives: Drug: Retifanlimab; Drug: Chemotherapy; Drug: 9-ING-41 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose Limiting Toxicities (DLTs)
Dose Limiting Toxicities DLTs Adverse Events The National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 Treatment related Dose Limiting Toxicities (DLTs) will be monitored through the first 2 cycles of the study therapy (28 days). Follow up safety assessments will continue beyond the first 28 days and throughout the treatment on the trial to monitor for late onset treatment related adverse effects or toxicities
Measured: Up to 28 days after start of treatment
Secondary outcomes (8)
Disease control rate (DCR) - imRECIST
Stable disease for ≥ 16 weeks, confirmed complete response (CR), or confirmed partial response (PR) during study treatment per Immune-Modified Response Evaluation Criteria in Solid Tumors (imRECIST ). CR: -100% Percent change (from baseline) in sum of the diameters (including measurable new lesions when present); PR: CR + ≤ 30% change from baseline; SD: > 30% to < +20% change from baseline.
Measured: Up to 24 months
Disease control rate (DCR) - RECIST v1.1
Stable disease for ≥ 16 weeks, confirmed complete response (CR), or confirmed partial response (PR) during study treatment. Per Response Evaluation Criteria in Solid Tumors (RECIST v1.1) Complete Response (CR) is disappearance of all target and non-target lesions; Partial Response (PR) is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters; Stable Disease (SD) is neither sufficient decrease (target lesions) to qualify as a PR or sufficient increase to qualify as PD. Incomplete Response/Stable Disease (SD) is the persistence of one or more non-target lesions.
Measured: Up to 24 months
Objective response rate (ORR)
Percent of patients with CR or PR imRECIST. Per Immune-Modified Response Evaluation Criteria in Solid Tumors (imRECIST ). CR: -100% Percent change (from baseline) in sum of the diameters (including measurable new lesions when present); PR: CR + ≤ 30% change from baseline.
Measured: Up to 24 months
Duration of response (DOR)
Time from documentation of tumor response to disease progression imRECIST. Per Immune-Modified Response Evaluation Criteria in Solid Tumors (imRECIST ). CR: -100% Percent change (from baseline) in sum of the diameters (including measurable new lesions when present); PR: CR + ≤ 30% change from baseline.
Measured: Up to 24 months
Progression free survival (PFS)
Time from study entry until objective tumor progression per Response Evaluation Criteria in Solid Tumors (RECIST v1.1) or death. Per RECIST, Progressive Disease (PD) is defined as at least a 20% increase in the sum of the diameters of target lesions compared to baseline sum of target lesions, or any new lesions. It also includes the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.
Measured: Up to 42 months
Overall survival (OS)
Time from study entry to death from any cause.
Measured: Up to 42 months
Time to treatment failure (TTF)
Time from study entry to disease progression, or death from disease, whichever occurs first.Per RECIST, Progressive Disease (PD) is defined as at least a 20% increase in the sum of the diameters of target lesions compared to baseline sum of target lesions, or any new lesions.It also includes the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.
Measured: Up to 42 months
Treatment related adverse events
Adverse Events and Serious Adverse Events per The National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 that are at least possibly related to study treatment measured from start of treatment to End of Treatment visit.
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2025
- Study start22 Sep 2025
- Primary completion30 Mar 2028 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic AdenocarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anwaar Saeed
- Sponsor type
- University, hospital or other
- Collaborators
- Actuate Therapeutics Inc., Incyte Corporation
- Responsible party
- Sponsor-investigator, Anwaar Saeed, University of Pittsburgh
- Investigators
- Anwaar Saeed, MD, Principal investigator, UPMC Hillman Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06896188
- Sponsor's protocol ID
- HCC 24-106
- Acronym
- RiLEY
- Status last verified
- Sep 2026
- First submitted
- 18 Mar 2025
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib Study of 9-ING-41 (Elraglusib), a Glycogen Synthase Kinase 3-beta (GSK-3β) Inhibitor, Combined With Retifanlimab, a PD-1 Inhibitor, Plus Modified FOLFIRINOX as Frontline Therapy for Patients With Advanced Pancreatic Adenocarcinoma (RiLEY)
- ClinicalTrials.gov ID
- NCT06896188
- Acronym / sponsor ID
- RiLEY / HCC 24-106
- Conditions
- Pancreatic Adenocarcinoma
- Keywords
- Glycogen Synthase Kinase 3-beta (GSK-3β) inhibitor, PD-1 inhibitor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Anwaar SaeedUniversity, hospital or other
- Collaborators
- Actuate Therapeutics Inc., Incyte Corporation
- Study start
- 22 Sep 2025 (actual)
- Primary completion
- 30 Mar 2028 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 26 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Given the role of GSK-3β in immune regulation, the combination of GSK-3β inhibition with PD 1 inhibition may be expected to provide synergistic anti-tumor efficacy. The excellent safety profile of 9-ING-41, along with preclinical and clinical evidence of anti-tumor activity in pancreatic cancer, provides a strong rationale to evaluate the efficacy of 9-ING-41 in combination with a PD 1 inhibitor plus standard chemotherapy (mFOLFIRINOX) as frontline therapy for patients with advanced PDAC. The PD-1 inhibitor to be used in the present study is retifanlimab, a humanized, hinge-stabilized immunoglobulin G4 (IgG4) monoclonal antibody. Retifanlimab has shown positive results for the treatment of patients with squamous carcinoma of the anal canal (SCAC) who have progressed after first-line chemotherapy treatment. In the Phase 2 PODIUM-202 trial, retifanlimab was well-tolerated at a dose of 500 mg administered via IV infusion every 4 weeks (28-day cycle) for up to 2 years.The combination of 9-ING-41 and retifanlimab with mFOLFIRINOX has not previously been administered to human subjects. In the 1801 study, 9-ING-41 has been administered in combination with various chemotherapy regimens including irinotecan,and has been well-tolerated. Retifanlimab alone has been well-tolerated when administered for up to 2 years in patients with anal cancer. Overall, based on previous nonclinical and clinical experience, both of these agents appear to have an acceptable safety profile and do not appear to have significant overlapping toxicities. However, it is possible that when they are administered together and in combination with mFOLFIRINOX, more frequent or severe AEs, or new AEs not previously observed with any of these agents administered alone, may occur. It is not known if administration of 9-ING-41 and retifanlimab will act synergistically to provide increased anti-tumor activity compared to mFOLFIRINOX alone. Subjects in this study should not expect to benefit directly by their participation in the study. The data collected in this study may benefit future cancer patients
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Retifanlimab + 9-ING-41 + Chemotherapy | Experimental | Drug: Retifanlimab, Drug: Chemotherapy, Drug: 9-ING-411. Chemotherapy: oxaliplatin 85 mg/m2 IV, leucovorin 400 mg/m2 IV, irinotecan 150 mg/m2 IV, and 5-FU continuous IV infusion 2400 mg/m2 over 46 hours every 14 days 2. Retifanlimab: IV at 500 mg on day 1 of every other cycle (Cycles 1, 3, 5, etc) 3.9-ING-41: IV at 9.3 mg/kg twice weekly (days 1, 3, 8 and 11) for the first 4 cycles, then weekly (days 1 and 8) thereafter |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- 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 procedures.
- 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 provide a standard fresh tumor biopsy prior to start of study treatment for molecular profiling of the tumor using standard institutional oncomine panel. If oncomine testing has previously been completed, a repeat biopsy or testing is not required.
Key exclusion criteria (25 listed)
- 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 severity per Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 (v5.0).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RetifanlimabAlso: ZYNYZ(PD-1)-blocking monoclonal antibody | Drug | Retifanlimab + 9-ING-41 + Chemotherapy |
| Chemotherapyoxaliplatin - Antineoplastic - Platinum Complexes Chemotherapy agent; leucovorin - a form of Folic acid helps the body produce and maintain new cells, and also helps prevent changes to DNA that may lead to cancer; irinotecan - anti-cancer medication used to treat colon cancer in combination with other chemotherapeutic agents; 5-FU - 5-fluorouracil is used to treat cancer in combination with other chemotherapeutic agents | Drug | Retifanlimab + 9-ING-41 + Chemotherapy |
| 9-ING-41Also: Elraglusiba maleimide-based ATP-competitive and selective glycogen synthase kinase-3β (GSK-3β) inhibitor with an IC50 of 0.71 μM. 9-ING-41 significantly leads to cell cycle arrest, autophagy and apoptosis in cancer cells | Drug | Retifanlimab + 9-ING-41 + Chemotherapy |
Primary outcome
Dose Limiting Toxicities (DLTs)
Time frame: Up to 28 days after start of treatment
Dose Limiting Toxicities DLTs Adverse Events The National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 Treatment related Dose Limiting Toxicities (DLTs) will be monitored through the first 2 cycles of the study therapy (28 days). Follow up safety assessments will continue beyond the first 28 days and throughout the treatment on the trial to monitor for late onset treatment related adverse effects or toxicities
8 secondary outcomes
Disease control rate (DCR) - imRECIST
Time frame: Up to 24 months
Disease control rate (DCR) - RECIST v1.1
Time frame: Up to 24 months
Objective response rate (ORR)
Time frame: Up to 24 months
Duration of response (DOR)
Time frame: Up to 24 months
Progression free survival (PFS)
Time frame: Up to 42 months
Overall survival (OS)
Time frame: Up to 42 months
Time to treatment failure (TTF)
Time frame: Up to 42 months
Treatment related adverse events
Time frame: Up to 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Pancreatic Adenocarcinoma
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingPhase 1
Modified FOLFIRINOX and Pentamidine in Advanced and Metastatic Pancreatic Cancer
Pancreatic Ductal Adenocarcinoma (PDAC)
RecruitingPhase 3
Atebimetinib + GnP as a First Line Treatment in Patients With Metastatic Pancreatic Adenocarcinoma
Pancreatic Cancer, Pancreatic Cancer Metastatic
RecruitingPhase 3
Study of Zoldonrasib + Chemo of Investigator's Choice vs Placebo + Chemo of Investigator's Choice as First-line Treatment in Metastatic KRAS G12D-mutated Pancreatic Adenocarcinoma ( RASolute 305 )
Pancreatic Cancer, Pancreatic Cancer Metastatic
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Anwaar Saeed, MD principal investigator
UPMC Hillman Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Retifanlimab, Chemotherapy and 9-ING-41 in people with Pancreatic Adenocarcinoma, run by Anwaar Saeed at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Debra Diecks, BSN (412-623-8364, diecksda@upmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose Limiting Toxicities (DLTs) (time frame: Up to 28 days after start of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026.