Pancreatic CancerNCT04566393
Expanded Access to Ulixertinib (BVD-523) in Patients With Advanced MAPK Pathway-Altered Malignancies
A study testing Ulixertinib (BVD-523) in people with Pancreatic Cancer and Small Bowel Cancer, run by xCures at 26 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Pancreatic Cancer, Small Bowel Cancer, Colorectal Cancer
- What is being tested?
- Ulixertinib (BVD-523)
- Type of treatment
- Pill or oral medicine
- How many people
- Not given
- Where
- 26 sitesUnited States
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- Child, Adult, Older adult
Who may be able to join
- 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:
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
26 sites in 1 country.
26 sites in 1 country
United States26 sites
- Available
Lehigh Valley Health Network
Allentown, Pennsylvania, 18103
Suresh Nair, MD
- Available
PCR Oncology
Arroyo Grande, California, 93420
David Palchak, MD
- Available
Our Lady of the Lake Hospital
Baton Rouge, Louisiana, 70808
Greg Bizette, MD
- Available
Mary Bird Perkins Cancer Center
Baton Rouge, Louisiana, 70809
Jon Olson, MD
- Available
Hirschfeld Oncology
Brooklyn, New York, 11206
Azriel Hirschfeld, MD
- Available
Mercy Medical Center
Cedar Rapids, Iowa, 52403
Susan Slycord, DO
- Available
Unity Point Health - St. Lukes Hospital
Cedar Rapids, Iowa, 52403
Bharat Jenigiri, MD
- Available
The Christ Hospital
Cincinnati, Ohio, 45219
Manish Bhandari, MD
- Available
Lake Region Healthcare
Fergus Falls, Minnesota, 56537
Anthony Rooney, MD
- Available
Hunterdon Hematology Oncology
Flemington, New Jersey, 08822
Waqas Rehman, MD
- Available
MD Anderson
Houston, Texas, 77030
Jodi Rodon Ahnert, MD
- Available
UTHealth Houston
Houston, Texas, 77030
Jay-Jiguang Zhu, MD
- Available
Nebraska Hematology Oncology
Lincoln, Nebraska, 68506
Madhu Midathada, MD
- Available
Cancer Partners of Nebraska
Lincoln, Nebraska, 68510
Nathan B. Green, DO
- Available
Monmouth Medical Center
Long Branch, New Jersey, 07740
Seth Cohen, MD
- Available
The Minniti Center for Medical Oncology and Hematology
Mickleton, New Jersey, 08056
Carl J. Minniti Jr., MD
- Available
Infirmary Cancer Care
Mobile, Alabama, 36604
Jose Galeas, MD
- Available
Hoag Memorial Hospital Presbyterian
Newport Beach, California, 92663
Michael Demeure, MD
- Available
Orlando Health
Orlando, Florida, 32806
Jennifer E. Tseng, MD
- Available
xCures Inc.
San Francisco, California, 94105
- Available
Providence Saint John's Health Center
Santa Monica, California, 90404
Naveed Wagle, MD
- Available
Oakland Macomb Cancer Specialists
Sterling Heights, Michigan, 48314
Mohammad Mobayed, MD
- Available
Stony Brook Cancer Center
Stony Brook, New York, 11794
MInsig Choi, MD
- Available
Atlantic Health System/Overlook Medical Center
Summit, New Jersey, 07901
Bonni Guerin, MD
- Available
UTHealth - Tyler
Tyler, Texas, 75701
Robert M Droder, MD
- Available
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, 20007
Benjamin A Weinberg, MD
About this study
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.
- Conditions
- Pancreatic Cancer, Small Bowel Cancer, Colorectal Cancer, Melanoma, Non Small Cell Lung Cancer, Thyroid Cancer
- Being tested
- Ulixertinib (BVD-523)
- Medical subject headings
- Pancreatic Neoplasms, Colorectal Neoplasms, Melanoma, Carcinoma, Non-Small-Cell Lung, Thyroid Neoplasms, Urinary Bladder Neoplasms, Head and Neck Neoplasms, Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ulixertinib (BVD-523)Drug
Ulixertinib (BVD-523) is an oral, first-in-class ERK1/2 inhibitor
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- xCures
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Cancer Commons
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04566393
- Sponsor's protocol ID
- ULI-EAP-100
- Status last verified
- Jun 2026
- First submitted
- 17 Sep 2020
- Last updated
- 4 Jun 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expanded Access to Ulixertinib (BVD-523) in Patients With Advanced MAPK Pathway-Altered Malignancies
- ClinicalTrials.gov ID
- NCT04566393
- Acronym / sponsor ID
- ULI-EAP-100
- Conditions
- Pancreatic Cancer, Small Bowel Cancer, Colorectal Cancer, Melanoma, Non Small Cell Lung Cancer, Thyroid Cancer
- Study type
- Expanded access
- Recruitment status
- Available
- Lead sponsor
- xCuresIndustry (pharma, biotech, devices)
- Collaborators
- Cancer Commons
- First posted
- 28 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (12 listed)
- 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:
- Note: Ulixertinib is primarily absorbed in the duodenum and therefore patients with any prior stomach or duodenal resection should be evaluated with that understanding.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ulixertinib (BVD-523)Ulixertinib (BVD-523) is an oral, first-in-class ERK1/2 inhibitor | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
26 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ulixertinib (BVD-523) in people with Pancreatic Cancer and Small Bowel Cancer, run by xCures at 26 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact xCures Clinical Operations ((707) 641-4475, expandedaccess@xcures.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026.