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Last-Resort cancer drug made available for patients with specific gene mutations

NCT ID NCT04566393

Disease control Sponsor: xCures Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access This study
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This program provides the experimental drug ulixertinib to people with advanced solid tumors that have certain gene mutations (MAPK pathway). It is for patients who have not responded well to or have run out of standard treatments. The goal is to control the disease and possibly shrink tumors, but it is not a cure.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

12 years and older

Sex

Anyone

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Main Inclusion Criterion: 1\. Patient has a MAPK pathway-altered solid tumor(s), including but not limited to KRAS, NRAS, HRAS, BRAF, MEK, and ERK mutations. * Other Inclusion Criteria: 1. In the opinion of the treating physician, the patient has exhausted or has inadequate response to available anti-cancer treatments. 2. In the opinion of the treating physician, the patient has adequate organ function to tolerate ulixertinib as defined in section 6.1 3. Male or female patients aged ≥ 12 years. 4. 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. 5. For females, evidence of post-menopausal status or negative urinary or serum pregnancy test for pre-menopausal patients. 6. 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. 7. 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 8. 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. Exclusion Criteria: 1. Patient is already participating in or qualifies for and is able to enroll in a clinical trial of ulixertinib (BVD-523). 2. Patient has received systemic therapy with an investigational agent within 5 half-lives or 14 days prior to starting ulixertinib treatment, whichever is shorter. 3. 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. 4. A history of current evidence/risk of retinal vein occlusion (RVO) or central serous retinopathy (CSR) 5. 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. 6. 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. 7. Known hypersensitivity to ulixertinib or any component in its formulation. 8. 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. 9. Patient is actively breastfeeding. 10. Prior stomach or duodenal resection that in the opinion of the treating physician would affect the breakdown and absorption of ulixertinib.

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Conditions

The condition(s) this trial relates to.

cholangiocarcinoma colorectal cancer colorectal neoplasm esophageal cancer Esophageal Neoplasms gastric cancer gastric neoplasm glioblastoma head and neck cancer Head and Neck Neoplasms hepatocellular carcinoma malignant pancreatic neoplasm melanoma non-small cell lung carcinoma ovarian cancer pancreatic neoplasm small intestine carcinoma thyroid cancer Thyroid Neoplasms urinary bladder carcinoma Urinary Bladder Neoplasms

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Bladder cancer BRAF gene mutation Cholangiocarcinoma Colorectal cancer Erk mutation Esophageal cancer Gastric cancer Glioblastoma Head and neck cancer Hepatocellular carcinoma Hras gene mutation KRAS activating mutation Mapk gene mutation MEK mutation Melanoma Non-small cell lung cancer NRAS gene mutation Ovarian cancer Pancreatic cancer Small bowel cancer Thyroid cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    26 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Atlantic Health System/Overlook Medical Center

    AVAILABLE

    Summit, New Jersey, 07901, United States

  • Cancer Partners of Nebraska

    AVAILABLE

    Lincoln, Nebraska, 68510, United States

  • Hirschfeld Oncology

    AVAILABLE

    Brooklyn, New York, 11206, United States

  • Hoag Memorial Hospital Presbyterian

    AVAILABLE

    Newport Beach, California, 92663, United States

  • Hunterdon Hematology Oncology

    AVAILABLE

    Flemington, New Jersey, 08822, United States

  • Infirmary Cancer Care

    AVAILABLE

    Mobile, Alabama, 36604, United States

  • Lake Region Healthcare

    AVAILABLE

    Fergus Falls, Minnesota, 56537, United States

  • Lehigh Valley Health Network

    AVAILABLE

    Allentown, Pennsylvania, 18103, United States

  • MD Anderson

    AVAILABLE

    Houston, Texas, 77030, United States

  • Mary Bird Perkins Cancer Center

    AVAILABLE

    Baton Rouge, Louisiana, 70809, United States

  • MedStar Georgetown University Hospital

    AVAILABLE

    Washington D.C., District of Columbia, 20007, United States

  • Mercy Medical Center

    AVAILABLE

    Cedar Rapids, Iowa, 52403, United States

  • Monmouth Medical Center

    AVAILABLE

    Long Branch, New Jersey, 07740, United States

  • Nebraska Hematology Oncology

    AVAILABLE

    Lincoln, Nebraska, 68506, United States

  • Oakland Macomb Cancer Specialists

    AVAILABLE

    Sterling Heights, Michigan, 48314, United States

  • Orlando Health

    AVAILABLE

    Orlando, Florida, 32806, United States

  • Our Lady of the Lake Hospital

    AVAILABLE

    Baton Rouge, Louisiana, 70808, United States

  • PCR Oncology

    AVAILABLE

    Arroyo Grande, California, 93420, United States

  • Providence Saint John's Health Center

    AVAILABLE

    Santa Monica, California, 90404, United States

  • Stony Brook Cancer Center

    AVAILABLE

    Stony Brook, New York, 11794, United States

  • The Christ Hospital

    AVAILABLE

    Cincinnati, Ohio, 45219, United States

  • The Minniti Center for Medical Oncology and Hematology

    AVAILABLE

    Mickleton, New Jersey, 08056, United States

  • UTHealth - Tyler

    AVAILABLE

    Tyler, Texas, 75701, United States

  • UTHealth Houston

    AVAILABLE

    Houston, Texas, 77030, United States

  • Unity Point Health - St. Lukes Hospital

    AVAILABLE

    Cedar Rapids, Iowa, 52403, United States

  • xCures Inc.

    AVAILABLE

    San Francisco, California, 94105, United States

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