Ulixertinib

Generic Name: Ulixertinib

Drug Type: Small Molecule

Chemical Formula: C_₂₁H_₂₂Cl_₂N_₄O_₂

CAS Number: 869886-67-9

Unique Ingredient Identifier: 16ZDH50O1U

Background: Ulixertinib is a a novel, reversible, ATP-competitive ERK1/2 inhibitor with high potency and ERK1/2 selectivity . It is currently in clinical trials for the treatment of a wide range of tumors.

Clinical Trials

A Study of Ruxolitinib in Combination With Ulixertinib in People With Myelofibrosis

Phase 1

Recruiting

Conditions: Myelofibrosis

Interventions: Drug: Ulixertinib
Drug: Ruxolitinib

First Posted Date: 2025-01-14

Last Posted Date: 2025-01-14

Lead Sponsor: Memorial Sloan Kettering Cancer Center

Target Recruit Count: 37

Registration Number: NCT06773195

Locations: 🇺🇸
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities), Basking Ridge, New Jersey, United States
🇺🇸
Memorial Sloan Kettering Monmouth (Limited Protocol Activities), Middletown, New Jersey, United States
🇺🇸
Memorial Sloan Kettering Nassau (Limited Protocol Activities), Uniondale, New York, United States

and more 6 locations

Ulixertinib in People With Histiocytic Neoplasms

Phase 2

Recruiting

Conditions: Histiocytic Neoplasms

Interventions: Drug: Ulixertinib

First Posted Date: 2024-05-13

Last Posted Date: 2024-10-23

Lead Sponsor: Memorial Sloan Kettering Cancer Center

Target Recruit Count: 38

Registration Number: NCT06411821

Locations: 🇺🇸
Memorial Sloan Kettering Basking Ridge (Consent Only), Basking Ridge, New Jersey, United States
🇺🇸
Memorial Sloan Kettering Monmouth (Limited Protocol Activities), Middletown, New Jersey, United States
🇺🇸
Memorial Sloan Kettering Bergen (Consent Only), Montvale, New Jersey, United States

and more 4 locations

Testing BVD-523FB (Ulixertinib) as Potentially Targeted Treatment in Cancers With Genetic Changes (MATCH - Subprotocol Z1L)

Phase 2

Active, not recruiting

Conditions: Advanced Lymphoma
Advanced Malignant Solid Neoplasm
Refractory Malignant Solid Neoplasm
Refractory Lymphoma
Refractory Multiple Myeloma

Interventions: Procedure: Biopsy Procedure
Procedure: Biospecimen Collection
Procedure: Computed Tomography
Procedure: Echocardiography Test
Procedure: Magnetic Resonance Imaging
Procedure: Radionuclide Imaging
Drug: Ulixertinib

First Posted Date: 2024-05-06

Last Posted Date: 2025-05-06

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 35

Registration Number: NCT06400225

Locations: 🇺🇸
ECOG-ACRIN Cancer Research Group, Philadelphia, Pennsylvania, United States

Open-label Phase 1b Study of Ulixertinib and Cetuximab or Ulixertinib in Combination With Cetuximab and Encorafenib in Patients With Unresectable or Metastatic Colorectal Cancer Who Have Previously Received EGFR or BRAF-directed Therapy

Phase 1

Recruiting

Conditions: Metastatic Colorectal Cancer

Interventions: Drug: Cetuximab
Drug: Ulixertinib
Drug: Encorafenib

First Posted Date: 2023-08-14

Last Posted Date: 2025-04-03

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 27

Registration Number: NCT05985954

Locations: 🇺🇸
M D Anderson Cancer Center, Houston, Texas, United States

Window-of-Opportunity Trial of Ulixertinib for MAPK-Activated Low-Grade Gliomas in Adults

Early Phase 1

Recruiting

Conditions: Gliomas

Interventions: Drug: Ulixertinib

First Posted Date: 2023-04-07

Last Posted Date: 2025-05-18

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 20

Registration Number: NCT05804227

Locations: 🇺🇸
M D Anderson Cancer Center, Houston, Texas, United States

Trial of Ulixertinib in Combination With Hydroxychloroquine in Patients With Advanced Gastrointestinal (GI) Malignancies

Phase 2

Terminated

Conditions: Tumor, Solid
Gastrointestinal Cancer

Interventions: Drug: Ulixertinib
Drug: Hydroxychloroquine

First Posted Date: 2022-02-02

Last Posted Date: 2024-07-22

Lead Sponsor: BioMed Valley Discoveries, Inc

Target Recruit Count: 47

Registration Number: NCT05221320

Locations: 🇺🇸
Cleveland Clinic, Cleveland, Ohio, United States
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Washington University School of Medicine, Saint Louis, Missouri, United States
🇺🇸
University of California San Francisco, San Francisco, California, United States

and more 6 locations

Expanded Access to Ulixertinib (BVD-523) in Patients With Advanced MAPK Pathway-Altered Malignancies

Conditions: Pancreatic Cancer
Small Bowel Cancer
Colorectal Cancer
Melanoma
Non Small Cell Lung Cancer
Thyroid Cancer
Bladder Cancer
Head and Neck Cancer
Gastric Cancer
Esophageal Cancer

First Posted Date: 2020-09-28

Last Posted Date: 2024-07-03

Lead Sponsor: xCures

Registration Number: NCT04566393

Locations: 🇺🇸
Unity Point Health - St. Lukes Hospital, Cedar Rapids, Iowa, United States
🇺🇸
Hunterdon Hematology Oncology, Flemington, New Jersey, United States
🇺🇸
Hirschfeld Oncology, Brooklyn, New York, United States

and more 20 locations

Study of Ulixertinib for Patients With Advanced Malignancies Harboring MEK or Atypical BRAF Alterations

Phase 2

Terminated

Conditions: Advanced Solid Tumor
BRAF Gene Mutation
BRAF Gene Alteration
MEK Mutation
MEK Alteration
MAP2K1 Gene Mutation
MAP2K1 Gene Alteration
MAP2K2 Gene Mutation
MAP2K2 Gene Alteration

Interventions: Drug: Ulixertinib
Drug: Physician's Choice

First Posted Date: 2020-07-27

Last Posted Date: 2024-06-04

Lead Sponsor: BioMed Valley Discoveries, Inc

Target Recruit Count: 104

Registration Number: NCT04488003

Locations: 🇺🇸
Massachusetts General Hospital, Boston, Massachusetts, United States
🇺🇸
Metro-Minnesota Community Oncology Research Consortium (MMCORC), Saint Louis Park, Minnesota, United States
🇺🇸
UPMC Hillman Cancer Center, Pittsburgh, Pennsylvania, United States

and more 17 locations

Ulixertinib (BVD-523) and Hydroxychloroquine in Patients W Advanced MAPK-Mutated Gastrointestinal Adenocarcinomas

Phase 1

Completed

Conditions: Gastrointestinal Neoplasms

Interventions: Drug: Ulixertinib
Drug: Hydroxychloroquine

First Posted Date: 2019-10-30

Last Posted Date: 2024-11-18

Lead Sponsor: University of Utah

Target Recruit Count: 16

Registration Number: NCT04145297

Locations: 🇺🇸
Huntsman Cancer Institute, Salt Lake City, Utah, United States

Ulixertinib in Treating Patients With Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With MAPK Pathway Mutations (A Pediatric MATCH Treatment Trial)

Phase 2

Active, not recruiting

Conditions: Recurrent Glioma
Recurrent Langerhans Cell Histiocytosis
Recurrent Malignant Germ Cell Tumor
Recurrent Malignant Solid Neoplasm
Recurrent Neuroblastoma
Recurrent Osteosarcoma
Refractory Malignant Germ Cell Tumor
Refractory Rhabdomyosarcoma
Refractory Soft Tissue Sarcoma
Wilms Tumor

Interventions: Other: Pharmacokinetic Study
Drug: Ulixertinib

First Posted Date: 2018-10-09

Last Posted Date: 2025-03-21

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 20

Registration Number: NCT03698994

Locations: 🇺🇸
AdventHealth Orlando, Orlando, Florida, United States
🇺🇸
Arnold Palmer Hospital for Children, Orlando, Florida, United States
🇺🇸
Nemours Children's Hospital, Orlando, Florida, United States

and more 105 locations

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