NCT05077800

FOLFIRINOX + Elraglusib + Losartan In Pancreatic Cancer

A Phase II Study of FOLFIRINOX Combined With the Glycogen Synthase Kinase-3 Beta (GSK-3 β) Inhibitor Elraglusib and the Transforming Growth Factor-β (TGF-β) Inhibitor Losartan in Patients With Untreated Metastatic Pancreatic Adenocarcinoma

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: Colin D. Weekes, M.D., PhD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to find out if an experimental drug will prevent metastatic pancreatic adenocarcinoma from becoming resistant to standard treatment for the disease. The names of the study drugs involved in this study are: * 9-ING-41 * Losartan * Ferumoxytol * FOLFIRINOX (made up of 4 different drugs): * 5-Fluorouracil (5-FU) * Oxaliplatin * Irinotecan * Leucovorin

Detailed description

This is a multi-institutional, open label, four-arm, non-comparator Phase 2 study of FOLFIRINOX in combination with 9-ING-41 and losartan for the treatment of adult patients with untreated metastatic pancreatic adenocarcinoma (PAC). This research study will begin with a Safety Run-In phase. The Safety Run-In phase will establish the side effects from the study treatment to its safety before beginning the main part of the study. Once that is complete, the main portion of the study will be a Phase II clinical trial. The U.S. Food and Drug Administration (FDA) has not approved 9-ING-41 as a treatment for pancreatic adenocarcinoma (PAC). The FDA has not approved Losartan for pancreatic adenocarcinoma (PAC), but it has been approved for other uses. The FDA has approved FOLFIRINOX as a treatment option for pancreatic adenocarcinoma (PAC). This research study involves giving participants an investigational drug called 9- ING-41 with standard anti-cancer drugs. 9-ING-41 stops an enzyme called GSK- 3β from working in cancer cells. Enzymes are proteins that activate and accelerate chemical reactions. The GSK-3β enzyme helps cancer cells to grow and to become resistant to chemotherapy drugs. This study is trying to see if by stopping the activity of GSK-3β using 9-ING-41, it may be possible for standard of care chemotherapy drugs to regain their effectiveness in treating cancers in participants where they have stopped being effective or are effective in only a minority of participants. FOLFIRINOX is a combination of 4 chemotherapy agents that may help shrink pancreatic adenocarcinoma (PAC) tumors. Losartan is a drug that is used to lower blood pressure. In this setting, Losartan has also been demonstrated to suppress TGF-β function in pancreatic adenocarcinoma. Cytokines are molecules that help cells communicate and play a role in immune response. Suppression of TGF-β function is believed to stop the cancer cells from becoming resistant to chemotherapy. This study will evaluate if blocking of GSK-3β activity using 9-ING-41 and blocking of TGF-β function using Losartan can inhibit cancer cell resistance to FOLFIRINOX chemotherapy. The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits. Participants will receive treatment during three portions of the study: Complete therapy, Maintenance therapy and Transition to complete therapy. After treatment, participants will be followed for up to 5 years. It is expected that up to 70 people will take part in this research study. Actuate Therapeutics, a pharmaceutical company, is supporting this research study by providing the study drug 9-ING-41. The Lustgarten Foundation is providing funding support for this study through a research grant.

Conditions

• Pancreatic Adenocarcinoma
• Pancreatic Adenocarcinoma Metastatic

Interventions

Type	Name	Description
DRUG	FOLFIRNINOX	Combination of 4 different drugs (5-Fluorouracil (5-FU), Oxaliplatin, Irinotecan and Leucovorin) administered by intravenous infusion
DRUG	Losartan	Taken Orally
DRUG	9-ING-41	Administered by intravenous infusion

Timeline

• Start date: 2022-03-21
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2021-10-14
• Last updated: 2026-04-13

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study