At a glance
ClinicalIndex Comparison Record- ✓Pathologically confirmed advanced, recurrent, or metastatic pancreatic cancer
- ✓Previously untreated with systemic agents in the advanced/metastatic setting
- ✓At least 1 measurable lesion per RECIST v1.1
- ✓Available archived FFPE tumor tissue or willing to provide fresh biopsy
- ✕Endocrine or acinar pancreatic carcinoma
- ✕Prior treatment with anti-PD-1, PD-L1 or PD-L2 agents
- ✕Known hypersensitivity to 9-ING-41, chemotherapeutic agents, or PD-1 inhibitor
- ✕Symptomatic rapidly progressive brain metastases or leptomeningeal involvement
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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)
In Brief
A Phase 1 clinical trial evaluating Retifanlimab, Chemotherapy, and 1 other intervention for Pancreatic Adenocarcinoma. Currently recruiting, targeting 12 participants across 1 site.
Detailed 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. 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.
Study Details
Timeline
Interventions
(PD-1)-blocking monoclonal antibody
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
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