Tumor, SolidPhase 2NCT05221320
Trial of Ulixertinib in Combination With Hydroxychloroquine in Patients With Advanced Gastrointestinal (GI) Malignancies
A Phase 2 study testing Ulixertinib and Hydroxychloroquine in people with Tumor, Solid and Gastrointestinal Cancer, run by BioMed Valley Discoveries, Inc at 9 sites in United States.
Trial summary
This is an open-label, prospective phase two basket trial assessing the efficacy of ulixertinib in combination with hydroxychloroquine in patients with advanced gastrointestinal malignancies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tumor, Solid, Gastrointestinal Cancer
- What is being tested?
- Ulixertinib and Hydroxychloroquine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 9 sitesUnited States
- Study dates
- 26 May 2022to 14 Jul 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patient aged ≥ 18 years.
- Histologically confirmed esophageal adenocarcinoma, esophageal squamous cell carcinoma, GEJ adenocarcinoma, gastric adenocarcinoma, pancreatic adenocarcinoma, intrahepatic cholangiocarcinoma, perihilar cholangiocarcinoma, extrahepatic cholangiocarcinoma, or colorectal adenocarcinoma harboring a MAPK-mutated GI malignancy: KRAS, NRAS, HRAS, BRAF non-V600, MEK 1/2 (MAP2K1/2), or ERK 1/2 (MAPK3/1).
- Progression on or during standard lines of therapy:
- Patients with intrahepatic cholangiocarcinoma, perihilar cholangiocarcinoma, or extrahepatic cholangiocarcinoma must have progressed during or after receiving a first-line regimen of gemcitabine/cisplatin unless deemed ineligible by the treating investigator to receive chemotherapy-based regimens due to prior comorbidities.
- Patients with pancreatic adenocarcinoma must have progressed during or after first-line therapy of FOLFIRINOX/ mFOLFIRINOX, gemcitabine/nab-paclitaxel unless deemed ineligible by the treating investigator to receive chemotherapy-based regimens due to prior comorbidities.
- Patients with colorectal adenocarcinoma must have progressed during or after their first two lines of therapy, including FOLFOX ± Avastin and FOLFIRI ± Avastin, unless deemed ineligible by the treating investigator to receive chemotherapy-based regimens due to prior comorbidities.
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- Patients with esophageal adenocarcinoma, esophageal squamous cell carcinoma, GEJ adenocarcinoma, or gastric adenocarcinoma must have progressed during or after their first two lines of therapy.
- Acceptable first-line regimens: FOLFOX, 5-FU/Cisplatin, FOLFIRI, Paclitaxel/Cisplatin or Carboplatin, Docetaxel/Cisplatin, DCF (or modifications thereof), or ECF (or modifications thereof) unless deemed ineligible by the treating investigator to receive chemotherapy-based regimens due to prior comorbidities.
- Acceptable second-line regimens: Ramucirumab/Paclitaxel, Docetaxel, Paclitaxel, Irinotecan, Trifluridine/Tipiracil, or FOLFIRI, unless deemed ineligible by the treating investigator to receive chemotherapy-based regimens due to prior comorbidities.
- Patients with deficient MisMatch Repair/High levels of MicroSatellite Instability (dMMR/MSI-H) tumors must have progressed during or after pembrolizumab.
- Measurable disease by RECIST 1.1 criteria by computed tomography (CT) or magnetic resonance imaging (MRI).
- Willing to provide a biopsy at the time points indicated on the Schedule of Activities.
- Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1.
- Adequate organ function as defined as:
- Hematologic:
- Absolute neutrophil count (ANC) ≥ 1500/mm3
- Platelet count ≥ 100,000/mm3
- Hemoglobin ≥ 9 g/dL
- Hepatic:
- Total Bilirubin ≤ 1.5x institutional upper limit of normal (ULN)
- Asparate animotransferace /Alanine aminotransferase (AST(SGOT)/ALT(SGPT)) ≤ 3 × institutional ULN
- Patients with liver metastases will be allowed to enroll with AST and ALT levels ≤ 5 x ULN.
- Renal:
- Estimated creatinine clearance ≥ 50 mL/min by Cockcroft-Gault formula:
- Males:
- (140-age) × weight [kg] / serum creatinine [mgdL] × 72
- Females:
- ((140-age) × weight [kg] / serum creatinine [mgdL] × 72)×0.85
- For female patients: Negative serum pregnancy test within 72 hours prior to first dose of study drugs for women of childbearing potential. The following definitions apply:
- Women of childbearing potential, defined as a sexually mature woman:
- Has not been naturally post-menopausal for at least 12 consecutive months (i.e., who has had menses anytime in the preceding 12 consecutive months).
- Has not undergone menopause, surgical sterilization (bilateral oophorectomy or hysterectomy).
- Underwent surgical sterilization (bilateral oophorectomy or hysterectomy).
- Women not of childbearing potential:
- Amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments, if any.
- Underwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy or hysterectomy).
- Male and female patients of childbearing potential agree to use highly effective contraception throughout the study and at least 90 days after the last study treatment administration.
- Recovery to baseline or ≤ Grade 1 CTCAE v5.0 from toxicities related to any prior cancer therapy, unless considered clinically not significant by the treating investigator.
- Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines.
Who cannot join
- Received systemic antineoplastic therapy (including unconjugated therapeutic antibodies and toxin immunoconjugates) or any investigational therapy ≤ 14 days or within five half-lives prior to starting study treatment, whichever is shorter.
- Received radiotherapy ≤ 14 days prior to the first dose of study treatment.
- Note: Localized radiation therapy for the treatment of symptomatic bone metastasis is allowed during that timeframe.
- Undergone major surgery ≤ 3 weeks prior to starting study drug or who have not fully recovered from major surgery.
- The diagnosis of another malignancy within ≤ 3 years before study enrollment, except for those considered to be adequately treated with no evidence of disease or symptoms and/or will not require therapy during the study duration (i.e., basal cell or squamous cell skin cancer, carcinoma in situ of the breast, bladder or of the cervix, or low-grade prostate cancer with Gleason Score ≤ 6).
- Known uncontrolled brain metastases or cranial epidural disease.
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- Note: Patients with stable brain metastases either treated or being treated with a stable dose of steroids (<20 mg of prednisone daily or equivalent) or anticonvulsants, with no dose change within 4 weeks before the first study drug dose, and no anticipated dose change, are eligible. In the event of steroid taper post-radiation therapy, taper must be complete within 2 weeks before Baseline.
- History or current evidence of central serous retinopathy (CSR) or retinal vein occlusion (RVO) or current risk factors for RVO (e.g. uncontrolled glaucoma or ocular hypertension, history of hyperviscosity).
- Current evidence of uncontrolled, significant intercurrent illness including, but not limited to, the following conditions:
- Cardiovascular disorders:
- Congestive heart failure New York Heart Association Class 3 or 4, unstable angina pectoris, serious cardiac arrhythmias.
- Stroke (including transient ischemic attack [TIA]), myocardial infarction (MI), or other ischemic events, or thromboembolic event (eg, deep venous thrombosis, pulmonary embolism) within 3 months before the first dose.
- Duration of QT interval (QTc prolongation) defined as a QTcF > 500 ms.
- Known congenital long QT.
- Left ventricular ejection fraction < 50%.
- History of seizures
- Impairment of gastrointestinal function or gastrointestinal disease (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, or malabsorption syndrome).
- Any other condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures (e.g., infection/inflammation, intestinal obstruction, unable to swallow medication, [patients may not receive the drug through a feeding tube], social/ psychological issues, etc.)
- Prior stomach or duodenal resection that in the opinion of the Principal Investigator and Medical Monitor would affect the breakdown and absorption of the study medications. A patient with a feeding tube should also be excluded, as ulixertinib capsules cannot be broken apart.
- Known HIV infection with a detectable viral load within 6 months of the anticipated start of treatment.
- Note: Patients on effective antiretroviral therapy with an undetectable viral load within 6 months of the anticipated start of treatment are eligible for this trial.
- Active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination, radiographic findings, and tuberculosis (TB) testing in line with local practice), hepatitis B (known positive HBV surface antigen (HBsAg) result), or hepatitis C.
- Note: Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody [anti-HBc] and absence of HBsAg) are eligible. Patients positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA.
- Medical, psychiatric, cognitive or other conditions that may compromise the patient's ability to understand the patient information, give informed consent, comply with the study protocol or complete the study.
- Known prior severe hypersensitivity to investigational product (IP) or any component in its formulations (NCI CTCAE v5.0 Grade ≥ 3).
- Patients taking prohibited medications as described in protocol. A washout period of prohibited medications for a period of at least 5 half-lives or as clinically indicated should occur before the start of treatment.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Rogel Cancer Center, University of Michigan Health
Ann Arbor, Michigan, 48109
Cleveland Clinic
Cleveland, Ohio, 44195
University of Kansas Cancer Center
Fairway, Kansas, 66205
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903
Mount Sinai
New York, New York, 10029
Massey Cancer Center, Virginia Commonwealth University
Richmond, Virginia, 23298
University of California San Francisco
San Francisco, California, 94143
Washington University School of Medicine
St Louis, Missouri, 63110
University of Arizona Cancer Center
Tucson, Arizona, 85719
About this study
Official title: A Phase 2 Basket Trial of Ulixertinib (BVD-523) in Combination With Hydroxychloroquine in Patients With Advanced GI Malignancies Harboring Mitogen-activated Protein Kinase (MAPK) Pathway Mutations (BVD-523-HCQ)
This is an open-label, prospective phase two basket trial assessing the efficacy of ulixertinib in combination with hydroxychloroquine in patients with advanced gastrointestinal malignancies. All patients enrolled must have a mitogen-activated protein kinase (MAPK) activating mutation to be deemed eligible for trial participation. Each disease-based basket will open to enrollment in two-stages. The opening of stage two will be dependent on the observed responses in the patients enrolled in the first stage.
Read the detailed description
This is an open-label, multicenter, phase II basket study of ulixertinib in combination with hydroxychloroquine in patients with advanced gastrointestinal malignancies harboring rat sarcoma virus (RAS), a member of the rapidly accelerated fibrosarcoma (non-V600 BRAF), extracellular signal-regulated kinase (ERK), or mitogen-activated protein kinase (MEK) mutations. The trial will have five baskets based on disease primary as listed below.
Basket 1: Cholangiocarcinoma including intrahepatic cholangiocarcinoma, perihilar cholangiocarcinoma, or extrahepatic cholangiocarcinoma;
Basket 2: Pancreatic adenocarcinoma;
Basket 3: Colorectal adenocarcinoma;
Basket 4: Esophageal adenocarcinoma, esophageal squamous cell carcinoma, or gastroesophageal junction (GEJ) adenocarcinoma;
Basket 5: Gastric adenocarcinoma.
While the overall trial is a basket design, each basket will operate as a Simon two-stage design and therefore, will open to enrollment in two-stages.
Total enrollment for Stage 1 is targeted at approximately 65 patients with 13 patients per group. Additional patients may be enrolled as appropriate.
Total enrollment for Stage 2 is targeted to approximately 150 patients with up to 30 patients per group. Additional patients may be enrolled as appropriate.
- Conditions
- Tumor, Solid, Gastrointestinal Cancer
- Being tested
- Ulixertinib, Hydroxychloroquine
- Medical subject headings
- Neoplasms, Gastrointestinal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UlixertinibDrug
Also called BVD-523, BVD523
small molecule ERK 1/2 inhibitor
Autophagy inhibitor
| Study group | Role | What they receive |
|---|---|---|
| Stage 1 - 5 baskets included, based on primary disease | Experimental | Ulixertinib: 450mg twice daily (BID), orally, days 1-28
Hydroxychloroquine: 600mg BID, orally, days 1-28
Cycles repeat every 28 days in absence of disease progression or unacceptable toxicity Receives: Drug: Ulixertinib; Drug: Hydroxychloroquine |
| Stage 2 - basket expansion based on Stage 1 | Experimental | Ulixertinib: 450mg BID, orally, days 1-28
Hydroxychloroquine: 600mg BID, orally, days 1-28
Cycles repeat every 28 days in absence of disease progression or unacceptable toxicity Receives: Drug: Ulixertinib; Drug: Hydroxychloroquine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate as Defined by the Proportion of Patients Achieving a Confirmed Partial Response (PR) and Complete Response (CR) (Defined by Response Evaluation Criteria in Solid Tumors (RECIST 1.1) as Evaluated by the Local Treating Investigator.
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.", or similar definition that is accurate and appropriate.
Measured: from cycle 1 day 1 until safety follow-up visit (up to 24 months)
The Incidence and Frequency of Serious Adverse Events (SAEs) Characterized by Type, Severity (as Defined by the NCI CTCAE, Version 5.0), Seriousness, Duration, and Relationship to Study Treatment.
Reporting of any SAEs, all SAEs were collected/assessed at each study visit.
Measured: Baseline until safety follow-up visit (up to 24 months)
The Incidence and Frequency of Adverse Events (AEs), Characterized by Type, Severity (as Defined by the NCI CTCAE, Version 5.0), Seriousness, Duration, and Relationship to Study Treatment.
Reporting of any AEs, all AEs were collected/assessed at each study visit.
Measured: Baseline until safety follow-up visit (up to 24 months)
Secondary outcomes (1)
Progression-free Survival (PFS) as Defined as the Time From Study Drug Initiation to the Time of Documented Disease Progression (as Assessed by RECIST 1.1) or Death From Any Cause.
To assess the duration of efficacy of ulixertinib and hydroxychloroquine in patients with advanced, RAS, non-V600 BRAF, ERK, or MEK mutated gastrointestinal malignancies.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2022
- Study start26 May 2022
- Primary completion8 May 2024
- Study completion14 Jul 2024
Why it stopped: Lack of Enrollment for Remaining Open Baskets
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Tumor, SolidStudies 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- BioMed Valley Discoveries, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05221320
- Sponsor's protocol ID
- BVD-523-HCQ
- Status last verified
- Jul 2025
- First submitted
- 20 Dec 2021
- Last updated
- 25 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Basket Trial of Ulixertinib (BVD-523) in Combination With Hydroxychloroquine in Patients With Advanced GI Malignancies Harboring Mitogen-activated Protein Kinase (MAPK) Pathway Mutations (BVD-523-HCQ)
- ClinicalTrials.gov ID
- NCT05221320
- Acronym / sponsor ID
- BVD-523-HCQ
- Conditions
- Tumor, Solid, Gastrointestinal Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of Enrollment for Remaining Open Baskets
- Enrolment
- 47 participants (actual)
- Lead sponsor
- BioMed Valley Discoveries, IncIndustry (pharma, biotech, devices)
- Study start
- 26 May 2022 (actual)
- Primary completion
- 8 May 2024 (actual)
- Study completion
- 14 Jul 2024 (actual)
- First posted
- 2 Feb 2022 (actual)
- Results
- Posted 25 Sep 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an open-label, prospective phase two basket trial assessing the efficacy of ulixertinib in combination with hydroxychloroquine in patients with advanced gastrointestinal malignancies. All patients enrolled must have a mitogen-activated protein kinase (MAPK) activating mutation to be deemed eligible for trial participation. Each disease-based basket will open to enrollment in two-stages. The opening of stage two will be dependent on the observed responses in the patients enrolled in the first stage.
Detailed description
This is an open-label, multicenter, phase II basket study of ulixertinib in combination with hydroxychloroquine in patients with advanced gastrointestinal malignancies harboring rat sarcoma virus (RAS), a member of the rapidly accelerated fibrosarcoma (non-V600 BRAF), extracellular signal-regulated kinase (ERK), or mitogen-activated protein kinase (MEK) mutations. The trial will have five baskets based on disease primary as listed below.
Basket 1: Cholangiocarcinoma including intrahepatic cholangiocarcinoma, perihilar cholangiocarcinoma, or extrahepatic cholangiocarcinoma;
Basket 2: Pancreatic adenocarcinoma;
Basket 3: Colorectal adenocarcinoma;
Basket 4: Esophageal adenocarcinoma, esophageal squamous cell carcinoma, or gastroesophageal junction (GEJ) adenocarcinoma;
Basket 5: Gastric adenocarcinoma.
While the overall trial is a basket design, each basket will operate as a Simon two-stage design and therefore, will open to enrollment in two-stages.
Total enrollment for Stage 1 is targeted at approximately 65 patients with 13 patients per group. Additional patients may be enrolled as appropriate.
Total enrollment for Stage 2 is targeted to approximately 150 patients with up to 30 patients per group. Additional patients may be enrolled as appropriate.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stage 1 - 5 baskets included, based on primary disease | Experimental | Drug: Ulixertinib, Drug: HydroxychloroquineUlixertinib: 450mg twice daily (BID), orally, days 1-28 Hydroxychloroquine: 600mg BID, orally, days 1-28 Cycles repeat every 28 days in absence of disease progression or unacceptable toxicity |
| Stage 2 - basket expansion based on Stage 1 | Experimental | Drug: Ulixertinib, Drug: HydroxychloroquineUlixertinib: 450mg BID, orally, days 1-28 Hydroxychloroquine: 600mg BID, orally, days 1-28 Cycles repeat every 28 days in absence of disease progression or unacceptable toxicity |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (39 listed)
- Male or female patient aged ≥ 18 years.
- Histologically confirmed esophageal adenocarcinoma, esophageal squamous cell carcinoma, GEJ adenocarcinoma, gastric adenocarcinoma, pancreatic adenocarcinoma, intrahepatic cholangiocarcinoma, perihilar cholangiocarcinoma, extrahepatic cholangiocarcinoma, or colorectal adenocarcinoma harboring a MAPK-mutated GI malignancy: KRAS, NRAS, HRAS, BRAF non-V600, MEK 1/2 (MAP2K1/2), or ERK 1/2 (MAPK3/1).
- Progression on or during standard lines of therapy:
- Measurable disease by RECIST 1.1 criteria by computed tomography (CT) or magnetic resonance imaging (MRI).
- Willing to provide a biopsy at the time points indicated on the Schedule of Activities.
Key exclusion criteria (26 listed)
- Received systemic antineoplastic therapy (including unconjugated therapeutic antibodies and toxin immunoconjugates) or any investigational therapy ≤ 14 days or within five half-lives prior to starting study treatment, whichever is shorter.
- Received radiotherapy ≤ 14 days prior to the first dose of study treatment.
- Note: Localized radiation therapy for the treatment of symptomatic bone metastasis is allowed during that timeframe.
- Undergone major surgery ≤ 3 weeks prior to starting study drug or who have not fully recovered from major surgery.
- The diagnosis of another malignancy within ≤ 3 years before study enrollment, except for those considered to be adequately treated with no evidence of disease or symptoms and/or will not require therapy during the study duration (i.e., basal cell or squamous cell skin cancer, carcinoma in situ of the breast, bladder or of the cervix, or low-grade prostate cancer with Gleason Score ≤ 6).
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 |
|---|---|---|
| UlixertinibAlso: BVD-523, BVD523small molecule ERK 1/2 inhibitor | Drug | Stage 1 - 5 baskets included, based on primary disease, Stage 2 - basket expansion based on Stage 1 |
| HydroxychloroquineAutophagy inhibitor | Drug | Stage 1 - 5 baskets included, based on primary disease, Stage 2 - basket expansion based on Stage 1 |
Primary outcome
Overall Response Rate as Defined by the Proportion of Patients Achieving a Confirmed Partial Response (PR) and Complete Response (CR) (Defined by Response Evaluation Criteria in Solid Tumors (RECIST 1.1) as Evaluated by the Local Treating Investigator.
Time frame: from cycle 1 day 1 until safety follow-up visit (up to 24 months)
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.", or similar definition that is accurate and appropriate.
The Incidence and Frequency of Serious Adverse Events (SAEs) Characterized by Type, Severity (as Defined by the NCI CTCAE, Version 5.0), Seriousness, Duration, and Relationship to Study Treatment.
Time frame: Baseline until safety follow-up visit (up to 24 months)
Reporting of any SAEs, all SAEs were collected/assessed at each study visit.
The Incidence and Frequency of Adverse Events (AEs), Characterized by Type, Severity (as Defined by the NCI CTCAE, Version 5.0), Seriousness, Duration, and Relationship to Study Treatment.
Time frame: Baseline until safety follow-up visit (up to 24 months)
Reporting of any AEs, all AEs were collected/assessed at each study visit.
1 secondary outcome
Progression-free Survival (PFS) as Defined as the Time From Study Drug Initiation to the Time of Documented Disease Progression (as Assessed by RECIST 1.1) or Death From Any Cause.
Time frame: 18 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ulixertinib and Hydroxychloroquine in people with Tumor, Solid and Gastrointestinal Cancer, run by BioMed Valley Discoveries, Inc at 9 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 39 inclusion and 26 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: stopped early, as of the sponsor's last update on 25 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Response Rate as Defined by the Proportion of Patients Achieving a Confirmed Partial Response (PR) and Complete Response (CR) (Defined by Response Evaluation Criteria in Solid Tumors (RECIST 1.1) as Evaluated by the Local Treating Investigator. (time frame: from cycle 1 day 1 until safety follow-up visit (up to 24 months)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
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 25 Sep 2025.