5-fu

Phase 3

TToray Industries, Inc

5-fu is one of 171 therapeutic programs targeting Pancreatic Ductal Adenocarcinoma. It is currently in Phase 3.

Indications

Total Trials

Active Trials

170

Competitors

Pipeline

Status by Indication[2][1]

Indication

Pancreatic Ductal AdenocarcinomaRecruiting

Esophageal AdenocarcinomaRecruiting

Colorectal CancerActive, not recruiting

Solid TumorRecruiting

Malignant Solid TumorActive, not recruiting

Gastrointestinal CancerRecruiting

Locally Advanced Unresectable or Metastatic Solid Tumors Including Esophageal CancerActive, not recruiting

Pancreatic Ductal AdenocarcinomaPhase 1

Recruiting

Esophageal AdenocarcinomaPhase 2

Recruiting

Colorectal CancerPhase 3

Active, not recruiting

Solid TumorPhase 1

Recruiting

Malignant Solid TumorPreclinical

Active, not recruiting

Gastrointestinal CancerPreclinical

Recruiting

Locally Advanced Unresectable or Metastatic Solid Tumors Including Esophageal CancerPhase 2

Active, not recruiting

Competition

Competitive Landscape

348 competitors in Solid Tumor

#DrugCompanyPhaseTrials

5-fu

TToray Industries, Inc

Phase 3

1 2

Fludara

Sanofi

Preclinical

2 3

DATROWAY

Daiichi Sankyo

Preclinical

1 4

Sporanox

SSebela Pharmaceuticals Development LLC

Preclinical

3 5

Navmi

SSummit Therapeutics

Preclinical

1 6

Paxil

SSebela Pharmaceuticals Development LLC

Preclinical

1 7

Tulmimetostat

Novartis

Preclinical

1 8

Carboplatin AUC-5

Merck & Co.

Preclinical

1 9

Ifinatamab Deruxtecan

Daiichi Sankyo

Preclinical

1 10

IN10018

IInxMed (Shanghai) Co., Ltd.

Preclinical

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

Timeline

Expected Milestones

Q4 2026

Phase 3Active, not recruiting

Colorectal Cancer

NCT04776655

Q1 2027

Phase 2Active, not recruiting

Locally Advanced Unresectable or Metastatic Solid Tumors Including Esophageal Cancer

NCT05945823

PreclinicalActive, not recruiting

Malignant Solid Tumor

NCT04083599

Q2 2027

PreclinicalRecruiting

Gastrointestinal Cancer

NCT07056777

Q4 2027

Phase 2Recruiting

HER2-Positive Gastric Cancer

NCT06730373

Clinical

Trials by Indication[1]

Colorectal Cancer4 trials

A Randomized, Open-label, Phase 3 Trial of Petosemtamab + FOLFIRI/mFOLFOX6 Versus Cetuximab or Bevacizumab + FOLFIRI/mFOLFOX6 as Second-line Treatment in Participants With RAS and BRAF Wild-type, Recurrent, Unresectable or Metastatic Colorectal Cancer

Recruiting· Genmab logo

Genmab·Phase 3·NCT07775287·600 enrolled

A Phase 1b, Multicenter Study to Determine the Dose, Safety, Efficacy and Pharmacokinetics of TRK-950 When Used in Combinations With Selected Anti-Cancer Treatment Regimens in Patients With Selected Advanced Solid Tumors

Completed·TToray Industries, Inc·Phase 1·NCT03872947·138 enrolled

An Phase II Study Evaluating the Safety and Efficacy of AMT-676 in Combination With 5-fluorouracil, Leucovorin, Bevacizumab (or Cetuximab) in Participants of Advanced Colorectal Cancer

Recruiting·MMultitude Therapeutics Inc.·Phase 2·NCT07474727·180 enrolled

Show 1 more trial

Phase III Study in mCRC Patients With RAS/BRAF Wild Type Tissue and RAS Mutated in LIquid BIopsy to Compare in First-line Therapy FOLFIRI Plus CetuxiMAb or BevacizumaB (LIBImAb Study)

Active, not recruiting·AAzienda USL Reggio Emilia - IRCCS·Phase 3·NCT04776655·280 enrolled

Esophageal Squamous Cell Carcinoma (ESCC)1 trial

A Randomized, Double-blind, Placebo-controlled Phase 3 Trial of Pembrolizumab (MK-3475) Versus Placebo in Participants With Esophageal Carcinoma Receiving Concurrent Definitive Chemoradiotherapy (KEYNOTE 975)

Completed· Merck & Co. logo

Merck & Co.·Phase 3·NCT04210115·703 enrolled

Gastric Adenocarcinoma1 trial

A Phase 3, Global, Multi-center, Double-blind, Randomized Study of ASP2138 Plus Chemotherapy (CAPOX or mFOLFOX6) With Pembrolizumab vs Placebo Plus Chemotherapy With or Without Pembrolizumab in First-line Treatment of Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma in Participants Whose Tumors Are HER2-negative and Claudin (CLDN) 18.2-positive

Recruiting· Astellas logo

Astellas·Phase 3·NCT07673887·570 enrolled

Esophageal Squamous Cell Carcinoma1 trial

A Phase II, Multicenter, Open-Label Study to Evaluate the Safety and Efficacy of SKB500 Combinations in Patients With Esophageal Squamous Cell Carcinoma

Recruiting·SSichuan Kelun-Biotech Biopharmaceutical Co., Ltd.·Phase 2·NCT07700667·120 enrolled

Bladder Cancer1 trial

A Phase 3 Study Evaluating Sacituzumab Tirumotecan Plus Subcutaneous Pembrolizumab and Berahyaluronidase Alfa (MK-3475A) as Induction Therapy, Followed by Local Therapy With Chemoradiation and MK-3475A Consolidation Versus Local Therapy With Chemoradiation in Participants With MIBC Who Elect Bladder Preservation

Not yet recruiting· Merck & Co. logo

Merck & Co.·Phase 3·NCT07829783·400 enrolled

13 more indications

Pleural Mesothelioma1 trial

A Phase 1a/1b Basket Trial of BMS-986504 With Standard-of-Care Therapy For Patients With Select Metastatic MTAP-deleted Solid Tumors

Recruiting·MMemorial Sloan Kettering Cancer Center·Phase 1·NCT07532902·60 enrolled

HER2-positive Gastric Cancer1 trial

A Phase II, Open-Label, Multicenter Trial Comparing Disitamab Vedotin Plus Sintilimab and S-1 With Trastuzumab Plus Chemotherapy ± Sintilimab for First-Line Treatment of HER2-Positive Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (RCTS2)

Recruiting·QQilu Hospital of Shandong University·Phase 2·NCT06730373·110 enrolled

Cervical Carcinoma1 trial

A Phase II, Multi-Center Study to Evaluate the Efficacy and Safety of Volrustomig as Monotherapy or in Combination With Anti-cancer Agents in Participants With Advanced/Metastatic Solid Tumors

Recruiting· AstraZeneca logo

AstraZeneca·Phase 2·NCT06535607·257 enrolled

Pancreatic Adenocarcinoma Advanced or Metastatic1 trial

Gemcitabine Plus Nab-PAclitaxel as Switch maiNTEnance Versus cONtinuation of Modified FOLFIRINOX as First-line Chemotherapy in Patients With Advanced Pancreatic Cancer: the PANThEON Phase III Trial

Recruiting·GGruppo Oncologico del Nord-Ovest·Phase 3·NCT06897644·340 enrolled

Pancreatic Ductal Adenocarcinoma1 trial

A Phase 1b Study of Neoadjuvant ASP2138 Monotherapy and Investigator's Choice of Adjuvant Chemotherapy in Participants With Resectable Pancreatic Ductal Adenocarcinoma Whose Tumors Have Claudin (CLDN) 18.2 Expression

Recruiting· Astellas logo

Astellas·Phase 1·NCT07024615·25 enrolled

Locally Advanced Unresectable or Metastatic Solid Tumors Including Esophageal Cancer1 trial

A Phase 2 Study of Futibatinib in Combination With PD-1 Antibody-based Standard of Care Therapy in Patients With Solid Tumors.

Active, not recruiting· Taiho Oncology, Inc. logo

Taiho Oncology, Inc.·Phase 2·NCT05945823·53 enrolled

Treatment Related Cancer1 trial

FIRE-5 -Study: Optimal Anti-EGFR Treatment of mCRC Patients With Low-Frequency RAS Mutation

Terminated·LLudwig-Maximilians - University of Munich·Phase 2·NCT04034173·3 enrolled

Gastric Neoplasms1 trial

A Phase III, Randomized, Double-blind Trial Comparing Trastuzumab Plus Chemotherapy and Pembrolizumab With Trastuzumab Plus Chemotherapy and Placebo as First-line Treatment in Participants With HER2 Positive Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (KEYNOTE 811)

Completed· Merck & Co. logo

Merck & Co.·Phase 3·NCT03615326·738 enrolled

Metastatic Esophageal Squamous Cell Carcinoma1 trial

A Phase 3, Randomized Study to Evaluate the Efficacy and Safety of Pembrolizumab (MK-3475) + Lenvatinib (E7080/MK-7902) + Chemotherapy Compared With Standard of Care as First-line Intervention in Participants With Metastatic Esophageal Carcinoma.

Terminated· Merck & Co. logo

Merck & Co.·Phase 3·NCT04949256·863 enrolled

Solid Tumor1 trial

A Phase I/II, Dose-Escalation and Dose-Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Antitumor Activities of CS2009, a Tri-specific Antibody Targeting PD-1/VEGFA/CTLA-4, as Monotherapy and Combination Therapy in Participants With Advanced Solid Tumors

Recruiting·CCStone Pharmaceuticals·Preclinical·NCT06741644·800 enrolled

Malignant Solid Tumor1 trial

A First-in-Human, Open-label, Dose-escalation Trial With Expansion Cohorts to Evaluate Safety and Anti-tumor Activity of GEN1042 in Subjects With Malignant Solid Tumors

Active, not recruiting· Genmab logo

Genmab·Preclinical·NCT04083599·350 enrolled

Gastrointestinal Cancer1 trial

A Phase Ib/IIa Clinical Trial Evaluating the Preliminary Efficacy and Safety of DR30206 in Combination With Standard Therapy in Patients With Gastrointestinal Tumors

Recruiting·ZZhejiang Doer Biologics Co., Ltd.·Preclinical·NCT07056777·186 enrolled

Esophageal Adenocarcinoma1 trial

Phase 2 Trial of 5-Fluorouracil, Oxaliplatin and Liposomal Irinotecan and Immunotherapy (Plus Trastuzumab for HER2-positive Disease) During 1st Line Treatment of Advanced Esophageal and Gastric Adenocarcinoma

Recruiting·UUniversity of Wisconsin, Madison·Phase 2·NCT04150640·52 enrolled

Sources

References

[1]
ClinicalTrials.gov — 21 trial records for 5-fu. U.S. National Library of Medicine, National Institutes of Health.
[2]
Open Targets Platform — Drug–disease associations for 5-fu. EMBL-EBI & Wellcome Sanger Institute.
[3]
SEC EDGAR — Toray Industries, Inc company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Highest Phase: Phase 3[1]
Company: TToray Industries, Inc

5-fu

Status by Indication[2][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q1 2027

Q2 2027

Q4 2027

Trials by Indication[1]

Colorectal Cancer4 trials

Esophageal Squamous Cell Carcinoma (ESCC)1 trial

Gastric Adenocarcinoma1 trial

Esophageal Squamous Cell Carcinoma1 trial

Bladder Cancer1 trial

Pleural Mesothelioma1 trial

HER2-positive Gastric Cancer1 trial

Cervical Carcinoma1 trial

Pancreatic Adenocarcinoma Advanced or Metastatic1 trial

Pancreatic Ductal Adenocarcinoma1 trial

Locally Advanced Unresectable or Metastatic Solid Tumors Including Esophageal Cancer1 trial

Treatment Related Cancer1 trial

Gastric Neoplasms1 trial

Metastatic Esophageal Squamous Cell Carcinoma1 trial

Solid Tumor1 trial

Malignant Solid Tumor1 trial

Gastrointestinal Cancer1 trial

Esophageal Adenocarcinoma1 trial

References

Drug Info

Quick Facts

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