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NCT05239182: RiLEY

9-ING-41 Plus Retifanlimab and Gemcitabine/Nab-Paclitaxel in Patients With Advanced Pancreatic Adenocarcinoma

Terminated Phase 2 Results posted Last updated 17 July 2025
What this trial tests

Phase 2 trial testing 9-ING-41 in Pancreatic Adenocarcinoma in 7 participants. Terminated before completion.

Timeline
26 January 2022
Primary endpoint
20 December 2022
4 February 2024

Quick facts

Lead sponsorAnwaar Saeed
PhasePhase 2
StatusTerminated
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment7
Start date26 January 2022
Primary completion20 December 2022
Estimated completion4 February 2024
Sites2 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

Anwaar Saeed

Who can join

18 and older, any sex, with Pancreatic Adenocarcinoma. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Disease Control Rate (DCR) Primary · Up to approximately 11 months from baseline

Percentage of patients with stable disease (SD), Complete Response (CR), or Partial Response (PR) for ≥16 weeks during treatment. Per RECIST v1.1, (CR): Disappearance of all target lesions. Any pathological lymph nodes (target or nontarget) with reduction in short axis to \<10 mm. (PR): ≥30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. Progressive Disease (PD): At least a 20% increas

GroupValue95% CI
9-ING-41 Plus Retifanlimab Plus Gem/Abraxane100
Best Response Secondary · Up to 12 months (from enrollment)

Number of patients with Complete Response (CR) or Partial Response (PR) or Stable Disease (SD) per RECIST v1.1 Per RECIST v1.1: Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (target or nontarget) with reduction in short axis to \<10 mm. Partial Response (PR): ≥30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. Progressive Disease (PD): At least a 2

GroupValue95% CI
9-ING-41 Plus Retifanlimab Plus Gem/Abraxane0
9-ING-41 Plus Retifanlimab Plus Gem/Abraxane2
9-ING-41 Plus Retifanlimab Plus Gem/Abraxane4
9-ING-41 Plus Retifanlimab Plus Gem/Abraxane0
Overall Response Rate (ORR) Secondary · Up to 12 months (from enrollment)

Percentage of patients with Complete Response (CR) or Partial Response (PR) per RECIST v1.1 Per RECIST v1.1: Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (target or nontarget) with reduction in short axis to \<10 mm. Partial Response (PR): ≥30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

GroupValue95% CI
9-ING-41 Plus Retifanlimab Plus Gem/Abraxane33
Adverse Events and Serious Adverse Events Secondary · Up to 12 months (from enrollment)

Number of participants with overall treatment-related adverse events (AE) and/or serious adverse events (SAE) at least possibly related as assessed by CTCAE v5.0.

Alanine aminotransferase increased
GroupValue95% CI
9-ING-41 Plus Retifanlimab Plus Gem/Abraxane2
Alopecia
GroupValue95% CI
9-ING-41 Plus Retifanlimab Plus Gem/Abraxane2
Anemia
GroupValue95% CI
9-ING-41 Plus Retifanlimab Plus Gem/Abraxane5
Anorexia
GroupValue95% CI
9-ING-41 Plus Retifanlimab Plus Gem/Abraxane1
Aspartate aminotransferase increased
GroupValue95% CI
9-ING-41 Plus Retifanlimab Plus Gem/Abraxane1
Ataxia
GroupValue95% CI
9-ING-41 Plus Retifanlimab Plus Gem/Abraxane1
Blurred vision
GroupValue95% CI
9-ING-41 Plus Retifanlimab Plus Gem/Abraxane1
Colitis
GroupValue95% CI
9-ING-41 Plus Retifanlimab Plus Gem/Abraxane1
Duration of Response (DOR) Secondary · Up to 12 months (from enrollment)

Time from documentation of tumor response to disease progression. Per RECISIT v1.1, Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (target or nontarget) with reduction in short axis to \<10 mm. Partial Response (PR): ≥30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. Progressive Disease (PD): At least a 20% increase in the sum

GroupValue95% CI
9-ING-41 Plus Retifanlimab Plus Gem/Abraxane5.2734.862 – 5.684
Progression-free Survival (PFS) Secondary · Up to 12 months (from enrollment)

Time from study enrollment until objective tumor progression or death. Per RECISIT v1.1, Progressive Disease (PD) is ≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). The sum must also demonstrate an absolute increase of ≥5 mm. The appearance ≥1 new lesion(s) is considered progression.

GroupValue95% CI
9-ING-41 Plus Retifanlimab Plus Gem/Abraxane6.7854814.970569 – 8.69
Overall Survival (OS) Secondary · Up to 24 months

Time patients are alive from study enrollment to death from any cause.

GroupValue95% CI
9-ING-41 Plus Retifanlimab Plus Gem/Abraxane10.725966.965337 – 20.40549

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse Events data collected for up to 12 months. All-Cause Mortality data collected for up to 24 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

9-ING-41 Plus Retifanlimab Plus Gem/Abraxane
Serious: 4/7 (57%)
Deaths: 4/7

Serious adverse events (5 terms)

ReactionSystem9-ING-41 Plus Retifanlimab…
SepsisInfections and infestations
Blood bilirubin increasedInvestigations
AnemiaBlood and lymphatic system disorders
ColitisGastrointestinal disorders
Thromboembolic eventVascular disorders
Other adverse events (56 terms — click to expand)

ReactionSystem9-ING-41 Plus Retifanlimab…
DiarrheaGastrointestinal disorders
AnemiaBlood and lymphatic system disorders
FatigueGeneral disorders
NauseaGastrointestinal disorders
Neutrophil count decreasedInvestigations
Weight lossGeneral disorders
Alanine aminotransferase increasedInvestigations
Edema limbsVascular disorders
Mucositis oralGastrointestinal disorders
Muscle crampMusculoskeletal and connective tissue disorders
Platelet count decreasedInvestigations
PruritusSkin and subcutaneous tissue disorders
AlopeciaSkin and subcutaneous tissue disorders
Aspartate aminotransferaceInvestigations
FeverGeneral disorders
HypokalemiaInvestigations
HypomagnesemiaInvestigations
Rash maculo-papularSkin and subcutaneous tissue disorders
Transient visual changes- things appearing darkerEye disorders
VomitingGastrointestinal disorders
White blood cell decreasedInvestigations
Abdominal painGastrointestinal disorders
AnorexiaMetabolism and nutrition disorders
ArthralgiaMusculoskeletal and connective tissue disorders
AscitesHepatobiliary disorders
AtaxiaNervous system disorders
Back painMusculoskeletal and connective tissue disorders
Bilateral peripheral neuropathyNervous system disorders
Blood bilirubin increasedInvestigations
ConstipationGastrointestinal disorders
CoughRespiratory, thoracic and mediastinal disorders
FallGeneral disorders
Febrile neutropeniaInvestigations
Flu like symptomsGeneral disorders
Gastroesophageal reflux diseaseGastrointestinal disorders
HeadacheNervous system disorders
HyperkalemiaInvestigations
HyponatremiaInvestigations
LeukocytosisBlood and lymphatic system disorders
Nail discolorationSkin and subcutaneous tissue disorders

Most-reported serious reactions: Sepsis, Blood bilirubin increased, Anemia, Colitis, Thromboembolic event.

Data from ClinicalTrials.gov NCT05239182 adverse events section.

Sponsor's own description

This trial examines how Pancreatic Adenocarcinoma reacts to the addition of 9-ING-41 and retifanlimab to the standard of care chemotherapy treatment, to see if using this combination will help and is able to effect disease progression.

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Elraglusib (9-ING-41), a selective small-molecule inhibitor of glycogen synthase kinase-3 beta, reduces expression of immune checkpoint molecules PD-1, TIGIT and LAG-3 and enhances CD8<sup>+</sup> T cell cytolytic killing of melanoma cells.
    Shaw G, Cavalcante L, Giles FJ, Taylor A. · · 2022 · cited 37× · PMID 36104795 · DOI 10.1186/s13045-022-01352-x
  2. When Just One Phosphate Is One Too Many: The Multifaceted Interplay between Myc and Kinases.
    Boi D, Rubini E, Breccia S, Guarguaglini G, et al · · 2023 · cited 8× · PMID 36902175 · DOI 10.3390/ijms24054746
  3. Advancing Immunotherapy in Pancreatic Cancer.
    Hegazi A, Rager LE, Watkins DE, Su KH. · · 2024 · cited 5× · PMID 39519112 · DOI 10.3390/ijms252111560
  4. Top advances of the year: Pancreatic cancer.
    Warren EAK, Lesinski GB, Maithel SK. · · 2023 · cited 5× · PMID 37776536 · DOI 10.1002/cncr.35031
  5. Natural Killer Cell-Mediated Antitumor Immunity: Molecular Mechanisms and Clinical Applications.
    Luo N, Chen C, Zhou W, Hao J, et al · · 2025 · cited 2× · PMID 40959206 · DOI 10.1002/mco2.70387
  6. Abstracts
    · 2024
  7. Elraglusib (9-ING-41), a selective small molecule inhibitor of Glycogen Synthase Kinase-3 beta, reduces expression of immune checkpoint molecules PD-1, TIGIT and LAG-3, and enhances CD8+ T cell cytolytic killing of melanoma cells.
    Shaw G, Cavalcante L, Giles F, Taylor A. · · 2022 · DOI 10.21203/rs.3.rs-1629579/v1

Verify or expand the search:

Other trials of 9-ING-41

Trials testing the same drug.

Other recruiting trials for Pancreatic Adenocarcinoma

Currently open trials in the same condition.

Other Anwaar Saeed trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05239182.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing