NCT05417386

FOLFIRINOX + NIS793 in Pancreatic Cancer

A Phase IB Study FOLFIRINOX and NIS793 in Patients With Pancreatic Cancer

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Colin D. Weekes, M.D., PhD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This research is being done to evaluate the safety and effectiveness of the drug NIS793 in combination with the standard of care treatment FOLFIRINOX (consists of the drugs 5-Fluorouracil (5-FU), Oxaliplatin, Irinotecan, and Leucovorin), chemoradiation and surgery for people with metastatic pancreas adenocarcinoma. The drugs involved in this study are: * NIS793 * FOLFIRINOX (consists of the drugs 5-Fluorouracil (5-FU), Oxaliplatin, Irinotecan, and Leucovorin) Other interventions include * chemoradiation * surgery.

Detailed description

This is a two part Phase 1B study investigating whether NIS793 improves the clinical benefit of FOLFIRINOX treatment for metastatic pancreas adenocarcinoma.The first part is a safety run-in using a dose escalation strategy to determine the recommended phase 2 dose of the drug NIS793. In the second part participants will be a randomized assigned to receive either FOLFIRINOX plus NIS793 or FOLFIRINOX alone. NIS793 binds to the protein that can be found on tumor cells, called TGFβ, thereby preventing its role in cancer metastasis (spreading). FOLFIRINOX is a combination of 4 chemotherapy drugs that may help shrink tumors. The U.S. Food and Drug Administration (FDA) has not approved NIS793 as a treatment for any disease. The FDA has approved FOLFIRINOX as a treatment option for metastatic pancreas adenocarcinoma The FDA has not approved the combination of NIS793 and FOLFIRINOX as a treatment for any disease. The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits. It is expected that about 50 people will take part in this research study. Novartis, a pharmaceutical company, is supporting this research study by providing funding for the study, including the study drug.

Conditions

• Pancreas Cancer
• Metastatic Pancreatic Cancer
• Metastatic Pancreatic Adenocarcinoma

Interventions

Type	Name	Description
DRUG	FOLFIRINOX	Combination of the drugs 5-Fluorouracil (5-FU), Oxaliplatin, Irinotecan, and Leucovorin given by intravenous infusion
DRUG	Oxaliplatin	Part of the FOLFIRINOX drug combination, given by intravenous infusion
DRUG	Leucovorin	Part of the FOLFIRINOX drug combination, given by intravenous infusion
DRUG	Irinotecan	Part of the FOLFIRINOX drug combination, given by intravenous infusion
DRUG	5-Fluorouracil (5-FU)	Part of the FOLFIRINOX drug combination, given by intravenous infusion
DRUG	NIS793	Given by intravenous infusion
RADIATION	Chemoradiation	Combination of Chemo (Capecitabine) and Radiation Therapy
DRUG	Capecitabine	Taken Orally as part of Chemoradiation
RADIATION	Radiation Therapy	Radiation Therapy as part of Chemoradiation
PROCEDURE	Surgery	Surgical removal of tumor

Timeline

• Start date: 2022-08-09
• Primary completion: 2023-07-10
• Completion: 2023-07-10
• First posted: 2022-06-14
• Last updated: 2025-11-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study