Expanded Access to Ulixertinib (BVD-523) in Patients With Advanced MAPK Pathway-Altered Malignancies
1 other identifier
expanded_access
N/A
1 country
27
Brief Summary
The objective of this expanded access program is to provide ulixertinib (BVD-523) for compassionate use in advanced cancer patients with MAPK pathway-altered solid tumor(s), including but not limited to KRAS, NRAS, HRAS, BRAF, MEK, and ERK mutations who have incomplete response to or have exhausted available therapies. Ulixertinib is available for treatment as monotherapy or in combination with other clinically tolerable agent(s), conditionally approved by the drug manufacturer.
Trial Health
Trial Health Score
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27 active sites
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 17, 2020
CompletedFirst Posted
Study publicly available on registry
September 28, 2020
CompletedJanuary 28, 2026
January 1, 2026
September 17, 2020
January 26, 2026
Conditions
Interventions
Ulixertinib (BVD-523) is an oral, first-in-class ERK1/2 inhibitor
Eligibility Criteria
You may qualify if:
- \. Patient has a MAPK pathway-altered solid tumor(s), including but not limited to KRAS, NRAS, HRAS, BRAF, MEK, and ERK mutations.
- In the opinion of the treating physician, the patient has exhausted or has inadequate response to available anti-cancer treatments.
- In the opinion of the treating physician, the patient has adequate organ function to tolerate ulixertinib as defined in section 6.1
- Male or female patients aged ≥ 12 years.
- Patient must be able to swallow and retain orally administered medication.
- Note: Ulixertinib is primarily absorbed in the duodenum and therefore patients with any prior stomach or duodenal resection should be evaluated with that understanding.
- For females, evidence of post-menopausal status or negative urinary or serum pregnancy test for pre-menopausal patients.
- Highly effective contraception for both male and female patients throughout the treatment and for at least 4 months after last treatment administration. In patients under the age of 18, who are not sexually active, abstinence is an acceptable form.
- Toxicities related to any prior treatments are either stable, stable on supportive therapy, resolved, or in the opinion of the treating physician, clinically non-significant
- Ability to understand a written informed consent document, and the willingness to sign it. Assent will be obtained when appropriate based on the patient's age.
You may not qualify if:
- Patient is already participating in or qualifies for and is able to enroll in a clinical trial of ulixertinib (BVD-523).
- Patient has received systemic therapy with an investigational agent within 5 half-lives or 14 days prior to starting ulixertinib treatment, whichever is shorter.
- Patient has received radiotherapy within 14 days prior to the first dose of ulixertinib treatment other than for the allowable treatment of symptomatic bone metastasis.
- A history of current evidence/risk of retinal vein occlusion (RVO) or central serous retinopathy (CSR)
- Current evidence of uncontrolled, significant intercurrent illness that would, in the treating physician's judgment, contraindicate the patient's treatment with ulixertinib due to safety concerns.
- Patients who, in the opinion of the treating physician, have not fully recovered from recent major surgery to a sufficient extent to tolerate treatment with ulixertinib.
- Known hypersensitivity to ulixertinib or any component in its formulation.
- Patients taking prohibited medications as described in current Investigator's Brochure.
- Note: Patients who require treatment with Drugs that are strong inhibitors or inducers of CYP1A2, CYP2D6, and CYP3A4 (see Appendix 3) were excluded from the FIH study of ulixertinib and should be discussed with xCures to review if any potential benefits outweigh the potential risks.
- Patient is actively breastfeeding.
- Prior stomach or duodenal resection that in the opinion of the treating physician would affect the breakdown and absorption of ulixertinib.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- xCureslead
- Cancer Commonscollaborator
Study Sites (27)
Clearview Cancer Institute
Huntsville, Alabama, 35805, United States
Infirmary Cancer Care
Mobile, Alabama, 36604, United States
PCR Oncology
Arroyo Grande, California, 93420, United States
Hoag Memorial Hospital Presbyterian
Newport Beach, California, 92663, United States
xCures Inc.
San Francisco, California, 94105, United States
Providence Saint John's Health Center
Santa Monica, California, 90404, United States
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, 20007, United States
Orlando Health
Orlando, Florida, 32806, United States
Mercy Medical Center
Cedar Rapids, Iowa, 52403, United States
Unity Point Health - St. Lukes Hospital
Cedar Rapids, Iowa, 52403, United States
Our Lady of the Lake Hospital
Baton Rouge, Louisiana, 70808, United States
Mary Bird Perkins Cancer Center
Baton Rouge, Louisiana, 70809, United States
Oakland Macomb Cancer Specialists
Sterling Heights, Michigan, 48314, United States
Lake Region Healthcare
Fergus Falls, Minnesota, 56537, United States
Nebraska Hematology Oncology
Lincoln, Nebraska, 68506, United States
Cancer Partners of Nebraska
Lincoln, Nebraska, 68510, United States
Hunterdon Hematology Oncology
Flemington, New Jersey, 08822, United States
Monmouth Medical Center
Long Branch, New Jersey, 07740, United States
The Minniti Center for Medical Oncology and Hematology
Mickleton, New Jersey, 08056, United States
Atlantic Health System/Overlook Medical Center
Summit, New Jersey, 07901, United States
Hirschfeld Oncology
Brooklyn, New York, 11206, United States
Stony Brook Cancer Center
Stony Brook, New York, 11794, United States
The Christ Hospital
Cincinnati, Ohio, 45219, United States
Lehigh Valley Health Network
Allentown, Pennsylvania, 18103, United States
MD Anderson
Houston, Texas, 77030, United States
UTHealth Houston
Houston, Texas, 77030, United States
UTHealth - Tyler
Tyler, Texas, 75701, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- expanded access
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 17, 2020
First Posted
September 28, 2020
Last Updated
January 28, 2026
Record last verified: 2026-01