NCT05417386

FOLFIRINOX + NIS793 in Pancreatic Cancer

Terminated Phase 1 Last updated 18 November 2025

What this trial tests

Phase 1 trial testing FOLFIRINOX in Pancreas Cancer in 4 participants. Terminated before completion.

Timeline

9 August 2022

Primary endpoint
10 July 2023

10 July 2023

Quick facts

Lead sponsor	Colin D. Weekes, M.D., PhD
Phase	Phase 1
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	4
Start date	9 August 2022
Primary completion	10 July 2023
Estimated completion	10 July 2023
Sites	1 location across United States

Drugs / interventions tested

• FOLFIRINOX
• Oxaliplatin (Oxaliplatin) — full drug profile →
• Leucovorin (leucovorin) — full drug profile →
• Irinotecan (irinotecan) — full drug profile →
• 5-Fluorouracil (5-FU)
• NIS793
• Chemoradiation — full drug profile →
• Capecitabine (capecitabine) — full drug profile →
• Radiation Therapy
• Surgery

Conditions studied

• Pancreas Cancer — all drugs for Pancreas Cancer →
• Metastatic Pancreatic Cancer — all drugs for Metastatic Pancreatic Cancer →
• Metastatic Pancreatic Adenocarcinoma — all drugs for Metastatic Pancreatic Adenocarcinoma →

Sponsor

Colin D. Weekes, M.D., PhD — full company profile →

Who can join

18 and older, any sex, with Pancreas Cancer or Metastatic Pancreatic Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

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

1. TGF-β signaling in health, disease, and therapeutics.
   Deng Z, Fan T, Xiao C, Tian H, et al · · 2024 · cited 737× · PMID 38514615 · DOI 10.1038/s41392-024-01764-w
2. Cancer-associated fibroblasts in pancreatic ductal adenocarcinoma.
   Zhang T, Ren Y, Yang P, Wang J, et al · · 2022 · cited 142× · PMID 36284087 · DOI 10.1038/s41419-022-05351-1
3. TGF-beta signal transduction: biology, function and therapy for diseases.
   Tie Y, Tang F, Peng D, Zhang Y, et al · · 2022 · cited 97× · PMID 36534225 · DOI 10.1186/s43556-022-00109-9
4. Transforming Growth Factor-β Blockade in Pancreatic Cancer Enhances Sensitivity to Combination Chemotherapy.
   Qiang L, Hoffman MT, Ali LR, Castillo JI, et al · · 2023 · cited 56× · PMID 37263309 · DOI 10.1053/j.gastro.2023.05.038
5. Role of the Tumor Microenvironment in Regulating Pancreatic Cancer Therapy Resistance.
   Deng D, Patel R, Chiang CY, Hou P. · · 2022 · cited 37× · PMID 36230914 · DOI 10.3390/cells11192952
6. Targeting transforming growth factor beta signaling in metastatic osteosarcoma.
   Ge R, Huang GM. · · 2023 · cited 25× · PMID 38021074 · DOI 10.1016/j.jbo.2023.100513
7. New advances in cancer therapy targeting TGF-β signaling pathways.
   Shou M, Zhou H, Ma L. · · 2023 · cited 21× · PMID 38144669 · DOI 10.1016/j.omto.2023.100755
8. Tumor microenvironment as niche constructed by cancer stem cells: Breaking the ecosystem to combat cancer.
   Zhong H, Zhou S, Yin S, Qiu Y, et al · · 2025 · cited 16× · PMID 38866179 · DOI 10.1016/j.jare.2024.06.014