mFOLFIRINOX

Phase 3Small molecule

mFOLFIRINOX is one of 252 small molecule programs targeting Pancreatic Ductal Adenocarcinoma. It is currently in Phase 3.

Indications

Total Trials

Active Trials

251

Competitors

Pipeline

Status by Indication[3][1]

Indication

Pancreatic Ductal AdenocarcinomaRecruiting

Pancreatic AdenocarcinomaRecruiting

Rectum CancerRecruiting

Pancreatic CancerUnknown status

Solid TumorRecruiting

EfficacyRecruiting

Locally-Advanced Rectal CancerCompleted

Pancreatic Ductal Adenocarcinoma (PDAC)Recruiting

Stage III Colon CancerRecruiting

Pancreatic Ductal AdenocarcinomaPhase 1

Recruiting

Pancreatic AdenocarcinomaPhase 3

Recruiting

Rectum CancerPhase 1

Recruiting

Pancreatic CancerPhase 3

Unknown status

Solid TumorPhase 1

Recruiting

EfficacyPreclinical

Recruiting

Locally-Advanced Rectal CancerPhase 3

Completed

Pancreatic Ductal Adenocarcinoma (PDAC)Phase 2

Recruiting

Stage III Colon CancerPhase 3

Recruiting

Competition

Competitive Landscape

348 competitors in Solid Tumor

#DrugCompanyPhaseTrials

mFOLFIRINOX

Incyte

Phase 3

4 2

Zejula

GGlaxo Dba Glaxosmithkline

Preclinical

2 3

Proleukin

IIovance Biotherapeutics, Inc.

Preclinical

1 4

Epivir

GGlaxo Dba Glaxosmithkline

Preclinical

1 5

PD-1 Inhibitor

Johnson & Johnson

Preclinical

2 6

Carboplatin AUC-5

Merck & Co.

Preclinical

1 7

Soc

Pfizer

Preclinical

1 8

Interleukin 2

EEssen Biotech

Preclinical

2 9

IL-2

FFate Therapeutics

Preclinical

2 10

Cadonilimab

SShanghai Pharmaceuticals Holding Co., Ltd

Preclinical

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

Timeline

Expected Milestones

Q4 2026

Phase 1Active, not recruiting

Pancreatic Cancer

NCT04161755

Phase 1Active, not recruiting

Pancreatic Adenocarcinoma

NCT05209074

Phase 1Active, not recruiting

Metastatic Pancreatic Adenocarcinoma

NCT06396091

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 Cancer20 trials

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

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

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

Show 17 more trials

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

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

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

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

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

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

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

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

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

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

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

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

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

Pancreatic Adenocarcinoma Neoadjuvant Chemotherapy Before Surgery

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

Show 4 more trials

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

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

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

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

Completed·UUNICANCER·Phase 3·NCT01526135·493 enrolled

Ivosidenib + mFOLFIRINOX in Patients With Resectable Pancreatic Adenocarcinoma

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

Solid Tumor4 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 I Dose Escalation and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Clinical Activity of RO7836748 as Monotherapy and in Combination With Other Anti-Cancer Therapies in Participants With Advanced Solid Tumors With a RAS G12V Mutation

Not yet recruiting· Roche logo

Roche·Phase 1·NCT07905924·540 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

Show 1 more trial

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

Neoadjuvant FOLFIRINOX and Preoperative Chemoradiotherapy for Locally Advanced Rectal Cancer Patients

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

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

Completed·UUNICANCER·Phase 3·NCT01804790·461 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

14 more indications

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

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

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

Safety and Efficacy1 trial

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

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

PDAC - Pancreatic Ductal Adenocarcinoma1 trial

A Phase 1/1b Multiple Cohort Trial of ALTA3263 in Patients With Advanced Solid Tumors With KRAS Mutations

Recruiting·AAlterome Therapeutics, Inc.·Phase 1·NCT06835569·448 enrolled

PDAC1 trial

A Phase 1/2, Multicenter, Open-Label Study to Evaluate Safety, Tolerability & Antitumor Activity of TNG462 in Combination With Other Agents in Patients With Pancreatic Cancer With MTAP Loss and Pancreatic or Non-Small Cell Lung Cancer With MTAP Loss & RAS Mutation

Recruiting·TTango Therapeutics, Inc.·Preclinical·NCT06922591·183 enrolled

Metastatic Pancreatic Adenocarcinoma1 trial

A Phase 1 Open-label Study to Assess the Safety and Tolerability of Zolbetuximab (IMAB362) in Combination With Chemotherapy (mFOLFIRINOX) in Participants With CLDN18.2 Positive Metastatic Pancreatic Adenocarcinoma

Active, not recruiting· Astellas logo

Astellas·Phase 1·NCT06396091·12 enrolled

Colorectal Neoplasms1 trial

A Phase Ib, Multicenter, Randomized Study Evaluating the Safety and Activity of GDC-7035 With Anti-Cancer Therapies as First-Line Treatment in Patients With KRAS G12D-Mutated Unresectable Advanced or Metastatic Colorectal Cancer or Pancreatic Ductal Adenocarcinoma

Not yet recruiting· Roche logo

Roche·Phase 1·NCT07859085·388 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

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

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 — 49 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

Q4 2026

Q1 2027

Trials by Indication[1]

Pancreatic Cancer20 trials

Pancreatic Adenocarcinoma7 trials

Solid Tumor4 trials

Locally-advanced Rectal Cancer2 trials

Stage III Colon Cancer2 trials

Chemotherapy1 trial

Rectum Cancer1 trial

Pancreatic Ductal Adenocarcinoma1 trial

Colorectal Cancer1 trial

Safety and Efficacy1 trial

PDAC - Pancreatic Ductal Adenocarcinoma1 trial

PDAC1 trial

Metastatic Pancreatic Adenocarcinoma1 trial

Colorectal Neoplasms1 trial

BMS-9865041 trial

Pancreas Adenocarcinoma1 trial

Adenocarcinoma, Pancreatic Ductal1 trial

Pancreatic Carcinoma1 trial

Pancreatic Ductal Adenocarcinoma (PDAC)1 trial

References

Drug Info

Quick Facts

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