NCT05209074

Ivosidenib + mFOLFIRINOX in Patients With Resectable Pancreatic Adenocarcinoma

Active, enrolled Phase 1 Last updated 5 September 2025

What this trial tests

Phase 1 trial testing Ivosidenib in Pancreatic Ductal Adenocarcinoma in 16 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

8 September 2022

Primary endpoint
15 July 2026

31 December 2026

Quick facts

Lead sponsor	Case Comprehensive Cancer Center
Phase	Phase 1
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	16
Start date	8 September 2022
Primary completion	15 July 2026
Estimated completion	31 December 2026
Sites	1 location across United States

Drugs / interventions tested

• Ivosidenib (IVOSIDENIB) — full drug profile →
• mFOLFIRINOX

Conditions studied

• Pancreatic Ductal Adenocarcinoma — all drugs for Pancreatic Ductal Adenocarcinoma →
• Resectable Pancreatic Cancer — all drugs for Resectable Pancreatic Cancer →

Sponsor

Case Comprehensive Cancer Center — full company profile →

Who can join

Adults 18 to 80, any sex, with Pancreatic Ductal Adenocarcinoma or Resectable Pancreatic Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study is a single-arm, phase I trial, up to 16 participants with resectable PDA. The study will examine the efficacy of the mutant IDH1 inhibitor ivosidenib, in conjunction with standard-of-care mFOLFIRINOX in the neoadjuvant setting.

Publications & conference data

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

1. Altered metabolism in cancer: insights into energy pathways and therapeutic targets.
   Tufail M, Jiang CH, Li N. · · 2024 · cited 265× · PMID 39294640 · DOI 10.1186/s12943-024-02119-3
2. Small molecule inhibitors targeting the cancers.
   Liu GH, Chen T, Zhang X, Ma XL, et al · · 2022 · cited 127× · PMID 36254250 · DOI 10.1002/mco2.181
3. IDH1 Inhibition Potentiates Chemotherapy Efficacy in Pancreatic Cancer.
   Zarei M, Hajihassani O, Hue JJ, Loftus AW, et al · · 2024 · cited 18× · PMID 38843355 · DOI 10.1158/0008-5472.can-23-1895
4. Wild-type IDH1 inhibition enhances chemotherapy response in melanoma.
   Zarei M, Hajihassani O, Hue JJ, Graor HJ, et al · · 2022 · cited 18× · PMID 36153582 · DOI 10.1186/s13046-022-02489-w
5. Clinical Utility of Ivosidenib in the Treatment of IDH1-Mutant Cholangiocarcinoma: Evidence To Date.
   Uson Junior PLS, Borad MJ. · · 2023 · cited 5× · PMID 37746315 · DOI 10.2147/cmar.s326060
6. Metabolic plasticity in pancreatic cancer: The mitochondrial connection.
   Ghiglione N, Abbo D, Bushunova A, Costamagna A, et al · · 2025 · cited 4× · PMID 39736443 · DOI 10.1016/j.molmet.2024.102089
7. What's on the menu?: metabolic constraints in the pancreatic tumor microenvironment.
   Sheehan C, Muir A. · · 2025 · cited 3× · PMID 40662369 · DOI 10.1172/jci191940
8. The allosteric IDH1 inhibitor ivosidenib overcomes chemoresistance in intrahepatic cholangiocarcinoma models expressing wild-type IDH1.
   Li X, Song Z, Lin S, Luo M, et al · · 2026 · PMID 41842958 · DOI 10.1172/jci199730