mFOLFOX6

Phase 3Small molecule

Roche

mFOLFOX6 is one of 341 small molecule programs targeting Metastasis. It is currently in Phase 3.

Indications

Total Trials

Active Trials

340

Competitors

Pipeline

Status by Indication[3][1]

Indication

MetastasisRecruiting

Esophageal CancerActive, not recruiting

Metastatic Colorectal CancerNot yet recruiting

Colorectal CancerNot yet recruiting

Total Neoadjuvant TherapyRecruiting

Advanced or Metastatic Solid TumorsActive, not recruiting

Solid TumorsActive, not recruiting

Metastatic Breast CancerRecruiting

Locally-Advanced Rectal CancerNot yet recruiting

First-Line TreatmentRecruiting

MetastasisPhase 3

Recruiting

Esophageal CancerPhase 2

Active, not recruiting

Metastatic Colorectal CancerPhase 3

Not yet recruiting

Colorectal CancerPhase 3

Not yet recruiting

Total Neoadjuvant TherapyPhase 2

Recruiting

Advanced or Metastatic Solid TumorsPreclinical

Active, not recruiting

Solid TumorsPhase 2

Active, not recruiting

Metastatic Breast CancerPreclinical

Recruiting

Locally-Advanced Rectal CancerPhase 2

Not yet recruiting

First-Line TreatmentPhase 2

Recruiting

Showing 10 of 13 indications

Competition

Competitive Landscape

254 competitors in Colorectal Cancer

#DrugCompanyPhaseTrials

Opdivo

Bristol-Myers Squibb

Phase 3

25 2

TAS 102

Taiho Oncology, Inc.

Phase 3

8 3

mFOLFOX6

Roche

Phase 3

5 4

Adjuvant Chemotherapy

NNizhny Novgorod Regional Clinical Oncology Center

Phase 3

2 5

Cytokine-Induced Killer Cells

TThe First People's Hospital of Changzhou

Phase 3

2 6

SHR-A1811

Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Phase 3

1 7

Thymosin Alpha1

SSun Yat-sen University

Phase 3

1 8

IBI363

Innovent Biologics (Suzhou) Co. Ltd.

Phase 3

1 9

Biological Check-up

UUniversity Hospital, Bordeaux

Phase 3

1 10

Intravenous Methylene Blue

CChinese University of Hong Kong

Phase 3

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

Timeline

Expected Milestones

Q1 2027

Post-ApprovalNot yet recruiting

Colorectal Cancer

NCT07446465

Phase 2Recruiting

Locally-Advanced Rectal Cancer

NCT06812728

Q2 2027

Phase 2Active, not recruiting

Esophageal Cancer

NCT03110926

Q3 2027

Phase 3Not yet recruiting

Colorectal Cancer

NCT05427669

Phase 2Recruiting

Colorectal Cancer

NCT05571644

PreclinicalActive, not recruiting

Advanced Cancer

NCT04396821

Clinical

Trials by Indication[1]

Metastatic Colorectal Cancer10 trials

Post-resection/Ablation Chemotherapy in Patients With Metastatic Colorectal Cancer (FIRE-9 - PORT / AIO-KRK-0418)

Recruiting·DDominik Paul Modest·Phase 3·NCT05008809·507 enrolled

A Study of Avastin (Bevacizumab) in Combination With mFOLFOX6 in Treatment-Naïve Patients With Metastatic Colorectal Cancer With or Without K-RAS Mutations, and Comparison to Cetuximab

Withdrawn· Roche logo

Roche·Phase 3·NCT01338558

Safety and Effectiveness Study of Chemotherapy and Ziv-aflibercept to Treat Metastatic Colorectal Cancer

Withdrawn·NNSABP Foundation Inc·Phase 2·NCT01889680

Show 7 more trials

The Efficacy and Safety of Fruquintinib Plus FOLFIRI/FOLFOX as Second-line Treatment in Patients With RAS-mutant Metastatic Colorectal Cancer

Unknown status·FFudan University·Phase 2·NCT05634590·68 enrolled

Randomized Study Of Sunitinib Plus FOLFOX Versus Bevacizumab Plus FOLFOX In Metastatic Colorectal Cancer

Terminated· Pfizer logo

Pfizer·Phase 2·NCT00609622·191 enrolled

Randomized Phase II Study of SOL for Untreated Metastatic Colorectal Cancer

Completed· Taiho Pharmaceutical Co., Ltd. logo

Taiho Pharmaceutical Co., Ltd.·Phase 2·NCT00721916·107 enrolled

Maintenance Therapy With 5-FU/FA Plus Panitumumab vs. 5-FU/FA Alone After Prior Induction and Re-induction After Progress for 1st-line Treatment of Metastatic Colorectal Cancer

Completed·AAIO-Studien-gGmbH·Phase 2·NCT01991873·387 enrolled

A Study Combining mFOLFOX6 With Tivozanib or Bevacizumab in Patients With Metastatic Colorectal Cancer as First Line Therapy

Completed·AAVEO Pharmaceuticals, Inc.·Phase 2·NCT01478594·265 enrolled

A Clinical Study to Evaluate the Efficacy and Safety of Envafolimab Combined With Cetuxima-βand mFOLFOX6 in Patients With MSS, RAS/BRAF Wild-Type Metastatic Colorectal Cancer (mCRC)

Not yet recruiting·SSun Yat-sen University·Phase 2/3·NCT06959693·590 enrolled

PEAK: Panitumumab Plus mFOLFOX6 vs. Bevacizumab Plus mFOLFOX6 for First Line Treatment of Metastatic Colorectal Cancer (mCRC) Patients With Wild-Type Kirsten Rat Sarcoma-2 Virus (KRAS) Tumors

Completed· Amgen logo

Amgen·Phase 2·NCT00819780·285 enrolled

Colorectal Cancer5 trials

PDR001 in Combination With Bevacizumab and mFOLFOX6 as First Line Therapy in Patients With Metastatic MSS Colorectal Cancer

Terminated· Novartis logo

Novartis·Phase 1·NCT03176264·1 enrolled

Neoadjuvant Treatment With mFOLFOXIRI Plus Cadonilimab (AK104) Versus mFOLFOX6 in Locally Advanced Colorectal Cancer

Recruiting·SSun Yat-sen University·Phase 2·NCT05571644·143 enrolled

Adjuvant mFOLFOXIRI vs. mFOLFOX6 in MRD Positive Stage II-III Colorectal Cancer (AFFORD)

Not yet recruiting·YYanhong Deng·Phase 3·NCT05427669·340 enrolled

Show 2 more trials

FOLFOX Chemotherapy Combined With Fruquintinib and Serplulimab as First-Line Conversion Therapy for Initially Unresectable pMMR/MSS Colorectal Cancer

Not yet recruiting·YYe Xu·Phase 4·NCT07446465·42 enrolled

Study of Pembrolizumab in Combination With Chemotherapy for Patients With Advanced Colorectal Cancer

Completed·HHoosier Cancer Research Network·Phase 2·NCT02375672·30 enrolled

Locally-advanced Rectal Cancer4 trials

FOLFOX6 Totally Neoadjuvant Chemoradiation Therapy in Locally Advanced Rectal Cancer: A Real World Study

Unknown status·SSun Yat-sen University·Phase 2·NCT02887313·200 enrolled

Neoadjuvant mFOLFOX6 Chemotherapy Combined With Anti-PD-1 Therapy in MSS/pMMR Locally Advanced Rectal Cancer (FIRM02 Study)

Not yet recruiting·XXinhua Hospital, Shanghai Jiao Tong University School of Medicine·Phase 2·NCT07381400·128 enrolled

Neoadjuvant FOLFIRINOX and Preoperative Chemoradiotherapy for Locally Advanced Rectal Cancer Patients

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

Show 1 more trial

Preoperative Sequential Short-course Radiation Therapy and FOLFOX for Locally Advanced Rectal Cancer

Active, not recruiting·KKyungpook National University Hospital·Phase 2·NCT05673772·364 enrolled

Gastric Cancer4 trials

IV Ascorbic Acid in Advanced Gastric Cancer

Unknown status·SSun Yat-sen University·Phase 3·NCT03015675·200 enrolled

Varlitinib in Combination With mFOLFOX6 for Advanced or Metastatic Gastric Cancer (First Line)

Completed·AASLAN Pharmaceuticals·Phase 2/3·NCT03130790·52 enrolled

A Phase II Trial of Perioperative Chemotherapy With Oxaliplatin, 5-Fluorouracil, Leucovorin(MODIFIED FOLFOX6) in Patients With Locally Advanced Operable Gastric Cancer

Completed·SSeoul National University Hospital·Phase 2·NCT01851941·52 enrolled

Show 1 more trial

A Randomized, Multi-center, Double-blind, Placebo-controlled Phase 3 Study of Bemarituzumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Subjects With Previously Untreated Advanced Gastric or Gastroesophageal Junction Cancer With FGFR2b Overexpression

Completed· Amgen logo

Amgen·Phase 3·NCT05052801·547 enrolled

Hepatocellular Carcinoma3 trials

Adjuvant Chemotherapy Based on the Adenosine Triphosphate Tumor Chemosensitivity Assay for Hepatocellular Carcinoma After Liver Transplantation

Withdrawn·ZZhejiang University·Phase 2·NCT02580253

The Impact on Recurrence Risk of Adjuvant Transarterial Chemoinfusion (TAI) Versus Adjuvant Transarterial Chemoembolization (TACE) for Patients With Hepatocellular Carcinoma And Portal Vein Tumor Thrombosis (PVTT) After Hepatectomy : A Random, Controlled, Stage III Clinical Trial.

Unknown status·SSun Yat-sen University·Phase 3·NCT03192644·162 enrolled

The Impact on Recurrence Risk of Adjuvant Transarterial Chemoinfusion (TAI) for Patients With Hepatocellular Carcinoma And Microvascular Invasion (MVI) After Hepatectomy : A Random, Controlled, Stage III Clinical Trial.

Unknown status·SSun Yat-sen University·Phase 3·NCT03192618·290 enrolled

30 more indications

Advanced Solid Tumors3 trials

A Study to Assess the Safety, Pharmacokinetics and Anti Tumor Activity of UCB6114 Administered Intravenously to Participants With Advanced Solid Tumors

Completed· UCB logo

UCB·Phase 1/2·NCT04393298·93 enrolled

Alternative Dosing for CRLX101(NLG207) Alone, With Avastin and With mFOLFOX6 in Advanced Solid Tumors

Terminated·NNewLink Genetics Corporation·Phase 1·NCT02648711·41 enrolled

Study of TSR-033 With an Anti-programmed Cell Death-1 Receptor (PD-1) in Participants With Advanced Solid Tumors

Completed·TTesaro, Inc.·Phase 1·NCT03250832·111 enrolled

Colorectal Carcinoma3 trials

Study of Pembrolizumab (MK-3475) vs Standard Therapy in Participants With Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Stage IV Colorectal Carcinoma (MK-3475-177/KEYNOTE-177)

Completed· Merck & Co. logo

Merck & Co.·Phase 3·NCT02563002·307 enrolled

A Randomized, Open-label, Phase 3 Trial of Petosemtamab in Combination With mFOLFOX6 or FOLFIRI Versus Cetuximab in Combination With mFOLFOX6 or FOLFIRI as First-line Treatment for Participants With RAS and BRAF Wild-type, Unresectable or Metastatic, Left-sided Colorectal Cancer

Recruiting· Genmab logo

Genmab·Phase 3·NCT07702032·960 enrolled

A Phase Ib, Open-Label Study of EMB-01 in Combination With Chemotherapy in Patients With Unresectable or Metastatic Colorectal Cancer

Recruiting·SShanghai EpimAb Biotherapeutics Co., Ltd.·Phase 1·NCT07649655·120 enrolled

Patients With Advanced Solid Tumors2 trials

A Study of R1507 in Combination With Multiple Standard Chemotherapy Treatments in Patients With Advanced Solid Tumors

Terminated· Roche logo

Roche·Phase 1·NCT00811993·104 enrolled

GDC-0980 in Combination With a Fluoropyrimidine, Oxaliplatin, and Bevacizumab in Patients With Advanced Solid Tumors

Completed· Roche logo

Roche·Phase 1·NCT01332604·41 enrolled

Chemotherapy2 trials

A Trial of Perioperative CV301 Vaccination in Combination With Nivolumab and Systemic Chemotherapy for Metastatic CRC

Terminated·PPatrick Boland·Phase 2·NCT03547999·17 enrolled

Avastin in Combination With Chemotherapy for RAS Mutant Unresectable Colorectal Liver-limited Metastases

Completed·XXu jianmin·Phase 4·NCT01972490·241 enrolled

Maintenance Treatment2 trials

Cetuximab Maintenance Treatment Versus Continuation After Induction Therapy in mCRC

Unknown status·RRuijin Hospital·Phase 2/3·NCT02942706·200 enrolled

Cetuximab Monotherapy Maintenance Treatment in mCRC

Unknown status·RRuijin Hospital·Phase 2/3·NCT02978313·500 enrolled

Metastatic Colon Cancer1 trial

The Value of Palliative Primary Tumor Resection in Metastatic Colon Cancer

Unknown status·FFudan University·Phase 3·NCT04416854·627 enrolled

Completed·UUniversity of Florida·Phase 2·NCT01652976·44 enrolled

Total Neoadjuvant Therapy1 trial

Total Neoadjuvant Therapy in Rectal Cancer

Recruiting·NNational Cheng-Kung University Hospital·Phase 2·NCT06162650·42 enrolled

Pancreatic Ductal Adenocarcinoma1 trial

Study of Single Agent Idelalisib Followed by Idelalisib in Combination With Chemotherapy in Adults With Metastatic Pancreatic Ductal Adenocarcinoma

Terminated· Gilead logo

Gilead·Phase 1·NCT02468557·16 enrolled

Locally Advanced Colon Cancer1 trial

MFOLFOXIRI Plus PD-1 Inhibitor Vs MFOLFOX6 As Neoadjuvant Therapy for Locally Advanced Colon Cancer

Not yet recruiting·SSun Yat-sen University·Phase 2·NCT06890624·138 enrolled

Pancreatic Cancer1 trial

BKM120 + mFOLFOX6 in Advanced Solid Tumors With Expansion Cohort Pancreatic Cancer

Completed·UUNC Lineberger Comprehensive Cancer Center·Phase 1·NCT01571024·17 enrolled

Esophageal Cancer1 trial

Induction Chemotherapy for Locally Advanced Esophageal Cancer

Active, not recruiting·UUniversity of Rochester·Phase 2·NCT03110926·40 enrolled

Locally Advanced1 trial

mFOLFOX6 + Bevacizumab + PD-1 Monoclonal Antibody Vs. mFOLFOX6 in Locally Advanced pMMR/MSS CRC

Recruiting·JJun Huang·Phase 3·NCT06791512·166 enrolled

Solid Tumors1 trial

A Study of Durvalumab (MEDI4736) and Monalizumab in Solid Tumors

Active, not recruiting· AstraZeneca logo

AstraZeneca·Phase 1/2·NCT02671435·383 enrolled

Metastasis1 trial

A Study of Systemic Chemotherapy With/Without HAI in Patients With Initially Unresectable Colorectal Liver Metastasis

Recruiting·YYuhong Li·Phase 3·NCT02102789·142 enrolled

Adjuvant Treatment1 trial

Postoperative Hepatic Arterial Chemotherapy in High-risk Patients as Adjuvant Treatment After Resection of Colorectal Liver Metastases

Completed·GGustave Roussy, Cancer Campus, Grand Paris·Phase 2/3·NCT02494973·104 enrolled

First-line Treatment1 trial

Cadonilimab Combination Regimen as First-line Treatment for HER2-expressing GC/GEJ Patients

Recruiting·ZZhejiang Cancer Hospital·Phase 1/2·NCT06650332·90 enrolled

Rectal Cancer Patients1 trial

Trial of Nivolumab With FOLFOX After Chemoradiation in Rectal Cancer Patients

Active, not recruiting·BBaruch Brenner·Phase 2·NCT03921684·29 enrolled

Bevacizumab1 trial

A Study Assessing the Interchangeability Between TRS003 and Bevacizumab® For CRC

Unknown status·ZZhejiang Teruisi Pharmaceutical Inc.·Phase 3·NCT05378867·126 enrolled

Phase II Clinical Study1 trial

Phase II Clinical Study to Evaluate the Efficacy and Safety of HLX07+HLX10 +mFOLFOX6 or HLX07 Monotherapy in Patients With mCRC

Not yet recruiting· Shanghai Henlius Biotech logo

Shanghai Henlius Biotech·Phase 2·NCT05239650·50 enrolled

Advanced Biliary Tract Cancer1 trial

A Single Arm Phase II Trial of Zolbetuximab in Combination With mFOLFOX6 or CAPOX Chemotherapy in Claudin 18.2 Overexpressed Advanced or Metastatic Biliary Tract Cancers

Not yet recruiting·MMidhun Malla·Phase 2·NCT07723534·32 enrolled

Metastatic Breast Cancer1 trial

Beamion BCGC-1: A Phase Ib Dose Escalation and Phase II Dose Optimization, Randomized, Open-label, Multicenter Trial of Oral Zongertinib (BI 1810631) Alone or in Combination With Other Agents for the Treatment of Patients With Advanced HER2+ Metastatic Breast Cancer (mBC), Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma (mGEAC), or Metastatic Colorectal Cancer (mCRC)

Recruiting· Boehringer Ingelheim logo

Boehringer Ingelheim·Preclinical·NCT06324357·910 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

Non-small Cell Lung Cancer (NSCLC)1 trial

A First-in-human Phase 1 Dose Escalation and Dose Expansion Study Evaluating the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of KST-6051 in Patients With Advanced or Metastatic Solid Tumors With a KRAS Mutation

Recruiting·KKestrel Therapeutics, Inc.·Phase 1·NCT07458347·545 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

Advanced Cancer1 trial

A Phase I/IIa Clinical Trial to Evaluate the Safety, Tolerability and Pharmacokinetics of TST001 Administered as Monotherapy or in Combination With Nivolumab or Standard of Care in Patients With Locally Advanced or Metastatic Solid Tumors

Active, not recruiting·SSuzhou Transcenta Therapeutics Co., Ltd.·Preclinical·NCT04396821·150 enrolled

Rectal Cancer1 trial

A Phase II Study of Total Neoadjuvant mFOLFOX6 Plus Suvemcitug and Enlonstobart With Selective Omission of Pelvic Radiotherapy for High-Risk Mid-Rectal Locally Advanced Rectal Cancer With MSS Status

Not yet recruiting·FFudan University·Phase 2·NCT07810114·52 enrolled

Stage II Colon Cancer1 trial

CIRCULATING TUMOR DNA BASED DECISION FOR ADJUVANT TREATMENT IN COLON CANCER STAGE II

Recruiting·CCentre Hospitalier Universitaire Dijon·Phase 3·NCT04120701·1,980 enrolled

Sources

References

[1]
ClinicalTrials.gov — 63 trial records for mFOLFOX6. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — mFOLFOX6 compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for mFOLFOX6. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Roche company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

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

mFOLFOX6

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q1 2027

Q2 2027

Q3 2027

Trials by Indication[1]

Metastatic Colorectal Cancer10 trials

Colorectal Cancer5 trials

Locally-advanced Rectal Cancer4 trials

Gastric Cancer4 trials

Hepatocellular Carcinoma3 trials

Advanced Solid Tumors3 trials

Colorectal Carcinoma3 trials

Patients With Advanced Solid Tumors2 trials

Chemotherapy2 trials

Maintenance Treatment2 trials

Metastatic Colon Cancer1 trial

Rectal Adenocarcinoma1 trial

Colon Cancer1 trial

Pancreatic Adenocarcinoma1 trial

Total Neoadjuvant Therapy1 trial

Pancreatic Ductal Adenocarcinoma1 trial

Locally Advanced Colon Cancer1 trial

Pancreatic Cancer1 trial

Esophageal Cancer1 trial

Locally Advanced1 trial

Solid Tumors1 trial

Metastasis1 trial

Adjuvant Treatment1 trial

First-line Treatment1 trial

Rectal Cancer Patients1 trial

Bevacizumab1 trial

Phase II Clinical Study1 trial

Advanced Biliary Tract Cancer1 trial

Metastatic Breast Cancer1 trial

PDAC - Pancreatic Ductal Adenocarcinoma1 trial

Non-small Cell Lung Cancer (NSCLC)1 trial

Colorectal Neoplasms1 trial

Advanced Cancer1 trial

Rectal Cancer1 trial

Stage II Colon Cancer1 trial

References

Drug Info

Quick Facts

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