mFOLFIRINOX

Phase 3Small molecule

Incyte

mFOLFIRINOX is one of 263 small molecule programs targeting Solid Tumor. It is currently in Phase 3.

Indications

Total Trials

Active Trials

262

Competitors

Pipeline

Status by Indication[3][1]

Indication

Solid TumorRecruiting

Pancreatic Ductal Adenocarcinoma (PDAC)Recruiting

Pancreas AdenocarcinomaRecruiting

BMS-986504Recruiting

Locally-Advanced Rectal CancerCompleted

Pancreatic Ductal AdenocarcinomaRecruiting

Rectum CancerRecruiting

Pancreatic CancerUnknown status

Pancreatic AdenocarcinomaRecruiting

Stage III Colon CancerRecruiting

Solid TumorPhase 1

Recruiting

Pancreatic Ductal Adenocarcinoma (PDAC)Phase 2

Recruiting

Pancreas AdenocarcinomaPhase 2

Recruiting

BMS-986504Phase 2

Recruiting

Locally-Advanced Rectal CancerPhase 3

Completed

Pancreatic Ductal AdenocarcinomaPhase 1

Recruiting

Rectum CancerPhase 1

Recruiting

Pancreatic CancerPhase 3

Unknown status

Pancreatic AdenocarcinomaPhase 3

Recruiting

Stage III Colon CancerPhase 3

Recruiting

Showing 10 of 11 indications

Competition

Competitive Landscape

348 competitors in Solid Tumor

#DrugCompanyPhaseTrials

mFOLFIRINOX

Incyte

Phase 3

3 2

Yervoy

Bristol-Myers Squibb

Preclinical

3 3

Nubeqa

Bayer

Preclinical

2 4

Fludara

Sanofi

Preclinical

1 5

Augtyro

KKaruna Therapeutics, Inc., a Bristol Myers Squibb company

Preclinical

2 6

Zejula

GGlaxo Dba Glaxosmithkline

Preclinical

2 7

Navmi

SSummit Therapeutics

Preclinical

1 8

Epivir

GGlaxo Dba Glaxosmithkline

Preclinical

1 9

PD-1 Inhibitor

Johnson & Johnson

Preclinical

1 10

Tulmimetostat

Novartis

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q3 2026

Phase 2Recruiting

Pancreatic Cancer

NCT06389760

Q4 2026

Phase 1Active, not recruiting

Pancreatic Cancer

NCT04161755

Phase 1Active, not recruiting

Pancreatic Adenocarcinoma

NCT05209074

Q1 2027

Phase 1Recruiting

Solid Tumor

NCT06179160

Phase 2Active, not recruiting

Pancreatic Adenocarcinoma

NCT03991962

Phase 2Recruiting

Locally-Advanced Rectal Cancer

NCT06812728

Clinical

Trials by Indication[1]

Pancreatic Cancer21 trials

Pancreatic Cancer With Elevated Serum CA125 Were Compared With Those Who Did Not Receive Neoadjuvant Chemotherapy.

Unknown status·FFudan University·Phase 3·NCT04835064·600 enrolled

Bortezomib Combined with PD-1 MAb and MFOLFIRINOX for Metastatic Pancreatic Cancer

Recruiting·ZZhejiang University·Phase 1/2·NCT06572813·63 enrolled

A Study of OT-101 With mFOLFIRINOX in Patients With Advanced and Unresectable or Metastatic Pancreatic Cancer

Recruiting·OOncotelic Inc.·Phase 2/3·NCT06079346·455 enrolled

Show 18 more trials

Nimotuzumab Combined With mFOLFIRINOX/GX as Postoperative Adjuvant Therapy in Pancreatic Cancer

Recruiting·TThe Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School·Phase 2·NCT06389760·57 enrolled

A Trial of NIS793 With FOLFIRINOX in Pancreatic Cancer

Terminated·—·Phase 2·NCT05546411·8 enrolled

A Study of Zolbetuximab With Chemotherapy in Adults With Pancreatic Cancer

Active, not recruiting· Astellas logo

Astellas·Phase 1·NCT06396091·12 enrolled

MFOLFIRINOX And Stereotactic Radiotherapy (SBRT) for Pancreatic Cancer With High Risk and Locally Advanced Disease

Unknown status·AAustralasian Gastro-Intestinal Trials Group·Phase 2·NCT04089150·120 enrolled

Combination Chemotherapy With or Without Hypofractionated Radiation Therapy Before Surgery in Treating Patients With Pancreatic Cancer

Unknown status·AAlliance for Clinical Trials in Oncology·Phase 2·NCT02839343·126 enrolled

mFOLFIRINOX as First-Line Chemotherapy in Treating Chinese Patients With Metastatic Pancreatic Cancer

Completed·YYuhong Li·Phase 2·NCT02028806·40 enrolled

Immunotherapy and SBRT Study in Borderline Resectable Pancreatic Cancer

Terminated·NNewLink Genetics Corporation·Phase 2·NCT02405585·10 enrolled

Study of Personalized Tumor Vaccines (PCVs) and a PD-L1 Blocker in Patients With Pancreatic Cancer That Can be Treated With Surgery

Active, not recruiting·MMemorial Sloan Kettering Cancer Center·Phase 1·NCT04161755·29 enrolled

A Study of Suizenji in Patients With Unresectable Pancreatic Cancer

Active, not recruiting·SSONIRE Therapeutics Inc.·N/A·NCT05601323·90 enrolled

A Study of Fluzoparib in Combination With mFOLFIRINOX in Patients With Advanced Pancreatic Cancer

Completed·JJiangsu HengRui Medicine Co., Ltd.·Phase 1/2·NCT04228601·39 enrolled

Study of Proton Therapy in Adjuvant Pancreatic Cancer

Completed·GGeorgetown University·Phase 1·NCT03885284·9 enrolled

Phase II Neoadjuvant Chemotheraphy (Gemcitabine and Nab-Paclitaxel vs. mFOLFIRINOX) and Sterotatic Body Radiation Therapy for Borderline Resectable Pancreatic Cancer

Terminated·NNathan Bahary, MD·Phase 2·NCT02241551·2 enrolled

Sequential Use of AG and mFOLFIRINOX as Neoadjuvant Chemotherapy for Resectable Pancreatic Cancer

Completed·SSecond Affiliated Hospital, School of Medicine, Zhejiang University·Phase 3·NCT03750669·324 enrolled

AG vs mFOLFIRINOX as Neoadjuvant Therapy for Borderline Reseactable and Locally Advanced Pancreatic Cancer

Unknown status·FFudan University·Phase 3·NCT04617821·300 enrolled

Phase II Randomized Trial of mFOLFIRINOX +/- Ramucirumab in Advanced Pancreatic Cancer

Completed·—·Phase 2·NCT02581215·84 enrolled

Surufatinib Plus mFOLFIRINOX and PD-1 Inhibitor as the Neoadjuvant Therapy for High-risk or Borderline Resectable Pancreatic Cancer

Not yet recruiting·SSun Yat-sen University·Phase 2·NCT07469956·30 enrolled

Intestinal Microbiota Impact for Prognosis and Treatment Outcomes in Early Luminal Breast Cancer and Pancreatic Cancer Patients

Unknown status·MMoscow Clinical Scientific Center··NCT05580887·35 enrolled

A Pilot Study of Neoadjuvant mFOLFIRINOX and ELI002-7P Treatment With or Without Tislelizumab in Borderline and Resectable Pancreatic Ductal Adenocarcinoma

Recruiting·MMemorial Sloan Kettering Cancer Center·Phase 1·NCT07671339·20 enrolled

Pancreatic Adenocarcinoma7 trials

mFOLFIRINOX With or Without Stereotactic Body Radiotherapy in Locally Advanced Pancreatic Adenocarcinoma

Active, not recruiting·—·Phase 2·NCT04986930·92 enrolled

Safety, Tolerability, and Efficacy of mFOLFIRINOX ± BNT321 as Adjuvant Therapy Following Curative Resection in Patients With Pancreatic Adenocarcinoma

Terminated· BioNTech logo

BioNTech·Phase 1/2·NCT06069778·1 enrolled

Pancreatic Adenocarcinoma Neoadjuvant Chemotherapy Before Surgery

Recruiting·HHamilton Health Sciences Corporation·Phase 2·NCT04452461·30 enrolled

Show 4 more trials

Phase II Study to Evaluate Modified Folfirinox and Stereotactic Body Radiation Therapy in Non-metastatic Unresectable Pancreatic Adenocarcinoma

Active, not recruiting·YYale University·Phase 2·NCT03991962·28 enrolled

Ivosidenib + mFOLFIRINOX in Patients With Resectable Pancreatic Adenocarcinoma

Active, not recruiting·—·Phase 1·NCT05209074·16 enrolled

Trial Comparing Adjuvant Chemotherapy With Gemcitabine Versus mFolfirinox to Treat Resected Pancreatic Adenocarcinoma

Completed·UUNICANCER·Phase 3·NCT01526135·493 enrolled

Risk-adapted Adjuvant Chemotherapy Guided by the Tumour Stage for Operated Pancreatic Adenocarcinoma Following Neoadjuvant Chemotherapy With mFOLFIRINOX

Recruiting·UUniversity Hospital, Rouen·Phase 2/3·NCT07044453·390 enrolled

Solid Tumor3 trials

An Open Label, Multicenter, Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetic/Pharmacodynamic Profile of M0324, a Bispecific (MUC-1 x CD40) Antibody as Monotherapy, in Combination With Pembrolizumab, and in Combination With Chemotherapy, in Participants With Selected Advanced Solid Tumors

Recruiting· EMD Serono Research & Development Institute, Inc. logo

EMD Serono Research & Development Institute, Inc.·Phase 1·NCT07166601·77 enrolled

A Phase 1, Open-Label, Multicenter Study of INCB186748 in Participants With Advanced or Metastatic Solid Tumors With KRAS G12D Mutation

Active, not recruiting· Incyte logo

Incyte·Phase 1·NCT06818812·30 enrolled

A Phase 1, Open-Label, Multicenter Study of INCB161734 in Participants With Advanced or Metastatic Solid Tumors With KRAS G12D Mutation

Recruiting· Incyte logo

Incyte·Phase 1·NCT06179160·710 enrolled

Locally-advanced Rectal Cancer2 trials

Efficacy of Neoadjuvant Folfirinox Regimen in Patients With Resectable Locally Advanced Rectal Cancer

Completed·UUNICANCER·Phase 3·NCT01804790·461 enrolled

Neoadjuvant FOLFIRINOX and Preoperative Chemoradiotherapy for Locally Advanced Rectal Cancer Patients

Recruiting·MMenoufia University·Phase 2·NCT06812728·100 enrolled

Stage III Colon Cancer2 trials

Adjuvant mFOLFIRINOX for High-risk Stage III Colon Cancer

Recruiting·—·Phase 2/3·NCT05179889·308 enrolled

Colon Adjuvant Chemotherapy Based on Evaluation of Residual Disease

Recruiting·NNRG Oncology·Preclinical·NCT05174169·1,912 enrolled

11 more indications

Safety and Efficacy1 trial

Safety and Efficacy of Modified Folfirinox Versus Gemcis in Bile Duct Tumours

Completed·—·Phase 2/3·NCT02591030·191 enrolled

Pancreatic Ductal Adenocarcinoma1 trial

MK2 Inhibitor in Combination With mFOLFIRINOX for Untreated Metastatic Pancreatic Ductal Adenocarcinoma

Recruiting·WWashington University School of Medicine·Phase 1·NCT06648434·51 enrolled

Efficacy1 trial

Study to Evaluate the Safety, Tolerability & Efficacy of TNG462 in Combination in PDAC & NSCLC Patients

Recruiting·TTango Therapeutics, Inc.·Phase 1/2·NCT06922591·183 enrolled

Chemotherapy1 trial

Short-course Versus Long-course Pre-operative Chemotherapy With mFOLFIRINOX or PAXG (CASSANDRA TRIAL)

Active, not recruiting·AAssociazione Italiana per lo Studio del Pancreas·Phase 3·NCT04793932·261 enrolled

Rectum Cancer1 trial

Preoperative Radiotherapy And ASTX660 in Rectum Cancer

Recruiting·GGustave Roussy, Cancer Campus, Grand Paris·Phase 1·NCT05912075·78 enrolled

Colorectal Cancer1 trial

Impact of FOLFIRINOX Chemotherapy in IV Stage Colorectal Cancer Patients Previously Exposed to Irinotecan, Fluoropyrimidine and Oxaliplatin

Unknown status·IInstituto do Cancer do Estado de São Paulo·Phase 2·NCT05354817·25 enrolled

Adenocarcinoma, Pancreatic Ductal1 trial

A Phase II, Open-Label, Multicenter, Randomized Study of the Efficacy and Safety of Adjuvant Autogene Cevumeran Plus Atezolizumab and mFOLFIRINOX Versus mFOLFIRINOX Alone in Patients With Resected Pancreatic Ductal Adenocarcinoma

Active, not recruiting· Roche logo

Roche·Phase 2·NCT05968326·260 enrolled

Pancreatic Carcinoma1 trial

Two Arm, Prospective, Multicenter Randomized Phase II Trial of Neoadjuvant Modified Folfirinox Regimen, With or Without Preoperative Concomitant Chemoradiotherapy in Patients With Borderline Resectable Pancreatic Carcinoma

Completed·IInstitut de Cancérologie de Lorraine·Phase 2·NCT02676349·130 enrolled

BMS-9865041 trial

A Phase II Study Evaluating BMS-986504 in MTAP-deleted Pancreatic Cancer

Recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT07283705·60 enrolled

Pancreas Adenocarcinoma1 trial

Sequential Neoadjuvant Chemotherapy for Borderline Resectable and Locally Advanced Pancreatic Adenocarcinoma

Recruiting·WWake Forest University Health Sciences·Phase 2·NCT05825066·64 enrolled

Pancreatic Ductal Adenocarcinoma (PDAC)1 trial

A Phase II, Multi-site, Randomized, Open-label, Trial of Pumitamig in Combination With Chemotherapy in Patients With Metastatic Pancreatic Cancer

Recruiting· BioNTech logo

BioNTech·Phase 2·NCT07255404·105 enrolled

Sources

References

[1]
ClinicalTrials.gov — 46 trial records for mFOLFIRINOX. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — mFOLFIRINOX compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for mFOLFIRINOX. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Incyte company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: Incyte

mFOLFIRINOX

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q3 2026

Q4 2026

Q1 2027

Trials by Indication[1]

Pancreatic Cancer21 trials

Pancreatic Adenocarcinoma7 trials

Solid Tumor3 trials

Locally-advanced Rectal Cancer2 trials

Stage III Colon Cancer2 trials

Safety and Efficacy1 trial

Pancreatic Ductal Adenocarcinoma1 trial

Efficacy1 trial

Chemotherapy1 trial

Rectum Cancer1 trial

Colorectal Cancer1 trial

Adenocarcinoma, Pancreatic Ductal1 trial

Pancreatic Carcinoma1 trial

BMS-9865041 trial

Pancreas Adenocarcinoma1 trial

Pancreatic Ductal Adenocarcinoma (PDAC)1 trial

References

Drug Info

Quick Facts

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