Primary Brain TumorPhase 2NCT07688356
Belvarafenib for CNS Efficacy in Patients With BRAF-Altered Solid Tumors
A Phase 2 study testing Belvarafenib in people with Primary Brain Tumor and Metastatic Brain Tumor, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
This is a Phase 2, open-label, single-arm clinical study designed to evaluate the efficacy and safety of Belvarafenib in patients with BRAF-altered primary brain tumors (Cohort 1) and metastatic brain tumors (Cohort 2). Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Primary Brain Tumor, Metastatic Brain Tumor
- What is being tested?
- Belvarafenib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- 15 Jun 2026to 31 Dec 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients aged 19 years or older.
- Histologically confirmed primary brain tumor or metastatic brain tumor.
- Documented BRAF mutation, including point mutations (e.g., V600E) or BRAF fusion mutations.
- Willing and able to provide written informed consent prior to participation in the study.
- Estimated life expectancy of at least 3 months.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
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- Adequate organ function demonstrated by laboratory assessments performed within 14 days prior to the first dose of study treatment, meeting all of the following criteria:
- Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L
- Hemoglobin ≥ 9 g/dL
- Platelet count ≥ 100 × 10⁹/L
- PT/INR and aPTT ≤ 1.5 × upper limit of normal (ULN)
- Total bilirubin ≤ 1.5 × ULN (≤ 3 × ULN for patients with Gilbert syndrome)
- AST and ALT ≤ 2.5 × ULN (≤ 5 × ULN in patients with liver metastases)
- Alkaline phosphatase ≤ 2.5 × ULN (≤ 5 × ULN in patients with liver or bone metastases)
- Albumin ≥ 2.5 g/dL
- Amylase ≤ 1.5 × ULN
- Serum creatinine ≤ 1.5 × ULN or calculated creatinine clearance (CrCl) > 50 mL/min using the Cockcroft-Gault formula
- Women of childbearing potential (defined as women from menarche until 1 year after menopause unless permanently sterile) and men with partners of childbearing potential must agree to use highly effective contraception throughout the study and for 3 months after the last dose of Belvarafenib.
- Women of childbearing potential must have a negative pregnancy test during screening unless surgically sterile.
- Acceptable contraceptive methods include:
- Hormonal contraception
- Intrauterine device (IUD) or intrauterine system (IUS)
- Vasectomy or bilateral tubal occlusion
- Complete abstinence Barrier methods (e.g., male or female condoms); if barrier methods are used alone, the use of two complementary barrier methods is recommended.
- Additional Inclusion Criteria for Cohort 1 (Primary Brain Tumors) 1) Patients with BRAF-mutant primary brain tumors who meet at least one of the following conditions:
- No available or appropriate local treatment options (e.g., surgery or radiotherapy);
- Radiographic evidence of disease recurrence or progression following standard therapy (including surgery and/or chemoradiotherapy [CCRT]), with no further suitable standard treatment available;
- Standard treatment is considered inappropriate or unavailable in the investigator's judgment.
- Additional Inclusion Criteria for Cohort 2 (Metastatic Brain Tumors)
- <!-- -->
- Patients with brain metastases from BRAF-mutant solid tumors.
- Patients with radiographic evidence of disease progression after receiving the standard treatment for the primary malignancy, or whose disease is refractory to conventional therapy, regardless of prior exposure to BRAF-targeted therapy, and who have no available or appropriate local treatment options (e.g., surgery or radiotherapy).
- At least one measurable intracranial lesion, with a maximum of five target lesions, as defined by the Response Assessment in Neuro-Oncology (RANO) criteria.
Who cannot join
- History of hypersensitivity to BRAF inhibitors or related compounds. Prior treatment with a BRAF inhibitor is permitted.
- Presence of hematologic malignancy or double primary malignancies at screening. The following second primary malignancies are permitted:
- Carcinoma in situ of the cervix successfully treated at least 1 year before enrollment;
- Papillary thyroid carcinoma treated with curative surgical resection;
- Completely resected cutaneous squamous cell carcinoma.
- Any of the following:
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- Receipt of an investigational medicinal product within 28 days or within five half-lives (whichever is longer) before the first dose of study treatment;
- Major surgery within 28 days before the first dose of study treatment;
- Newly initiated or recently increased systemic corticosteroid therapy equivalent to ≥10 mg/day of prednisolone within 28 days before the first dose.
- Patients receiving a stable dose for at least 2 weeks or requiring continued corticosteroid treatment after surgery may be enrolled at the investigator's discretion;
- Current treatment with systemic immunosuppressive agents or anticipated need for continuous systemic immunosuppression during the study. Topical preparations, inhaled corticosteroids, ophthalmic preparations, and local injections are permitted;
- More than five prior systemic anticancer treatment regimens.
- Unresolved adverse events of CTCAE Grade ≥2 from previous anticancer therapy at screening, except alopecia.
- Any of the following cardiovascular conditions:
- Mean QTcF >440 msec;
- New York Heart Association (NYHA) Class III or IV heart failure;
- Cardiac metastasis;
- Uncontrolled electrolyte abnormalities (hyponatremia, hypokalemia, hypocalcemia, or hypomagnesemia);
- Within 6 months before the first dose: unstable angina, acute coronary syndrome (including myocardial infarction), uncontrolled arrhythmia (except sinus arrhythmia or adequately controlled atrial fibrillation for at least 30 days), symptomatic congestive heart failure, cerebrovascular accident, or transient ischemic attack;
- Coronary angioplasty, coronary/peripheral artery bypass graft surgery, or coronary stent placement within 6 months before the first dose;
- History of congenital long QT syndrome or clinically significant CTCAE Grade ≥2 ventricular or atrial dysrhythmias.
- Any of the following ophthalmologic disorders:
- History or evidence at screening of retinal vein occlusion (RVO), central serous retinopathy (CSR), or neovascular macular degeneration;
- Intraocular pressure ≥21 mmHg with glaucoma.
- Current or prior interstitial lung disease (ILD), drug-induced ILD, or radiation pneumonitis requiring corticosteroid treatment.
- Uncontrolled hypertension.
- Uncontrolled infectious or neurologic disease, active infection requiring intravenous antibiotics, known human immunodeficiency virus (HIV) infection, active hepatitis B virus (HBV) infection, or active hepatitis C virus (HCV) infection.
- Inability to swallow oral tablets or any gastrointestinal condition that may interfere with the administration, absorption, or metabolism of Belvarafenib, including refractory nausea or vomiting, malabsorption syndrome, external biliary shunt, significant small bowel resection, clinically significant gastrointestinal bleeding, acute pancreatitis within 28 days before the first dose, or diverticulitis.
- Requirement for continuous treatment with CYP2C8 substrate medications (e.g., amodiaquine) or rifampin.
- Known or suspected substance abuse or alcohol abuse.
- Psychological, social, geographic, psychiatric, or congenital conditions that, in the investigator's judgment, would interfere with compliance with the study protocol or follow-up.
- Pregnant or breastfeeding women, or women of childbearing potential planning to become pregnant during the study.
- Any other medical condition, laboratory abnormality, or circumstance that, in the investigator's judgment, would make the participant unsuitable for study treatment.
- Additional Exclusion Criteria for Cohort 1 (Primary Brain Tumors) 1) New intracranial lesions identified within 12 weeks after prior brain radiotherapy when radiation necrosis cannot be reliably distinguished from tumor progression.
- Additional Exclusion Criteria for Cohort 2 (Metastatic Brain Tumors) 1) Clinically unstable disease due to uncontrolled primary malignancy. 2) Requirement for concurrent systemic anticancer therapy (e.g., chemotherapy, targeted therapy, or other systemic anticancer treatment) for extracranial disease during the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Samsung Medical Center
Seoul, 06351
Hyun Ae Jung, MD, PhD, +82-2, hyunae0608.jung@gmail.com
About this study
Official title: An Exploratory Phase 2 Study for Evaluating CNS Efficacy of Belvarafenib in Patients With BRAF-Altered Solid Tumors
This is a Phase 2, open-label, single-arm clinical study designed to evaluate the efficacy and safety of Belvarafenib in patients with BRAF-altered primary brain tumors (Cohort 1) and metastatic brain tumors (Cohort 2). Eligible patients are those with a confirmed BRAF alteration identified by next-generation sequencing (NGS).
Patients who meet the eligibility criteria will receive a detailed explanation of the study, including its purpose, procedures, potential benefits, and risks. Only patients who voluntarily provide written informed consent will be enrolled.
Read more
All enrolled patients will receive Belvarafenib monotherapy at a dose of 450 mg twice daily (BID). The study drug will be taken orally within 30 minutes after meals with at least 200 mL of water, preferably at approximately 12-hour intervals each day. One treatment cycle is defined as 28 consecutive days of continuous dosing without a planned treatment break. Patients will receive treatment for six cycles (approximately six months) as the initial treatment period. Treatment may be extended or discontinued earlier at the investigator's discretion based on clinical benefit, disease status, and tolerability.
During the study, patients will undergo regular clinical evaluations, including physical examinations, vital sign assessments, laboratory tests, and monitoring for adverse events. Radiologic assessments using MRI and/or CT will be performed at scheduled intervals to evaluate tumor response and disease progression. The study aims to determine whether Belvarafenib can control tumor growth, delay disease progression, and improve clinical outcomes in patients with BRAF-altered brain tumors.
If treatment-related toxicities occur, dose reductions are permitted according to the protocol. The dose may be reduced from 450 mg BID to 300 mg BID, and subsequently to 200 mg BID, if clinically indicated. Temporary treatment interruption may also be implemented until toxicity resolves. If unacceptable toxicity persists despite dose modification, treatment will be permanently discontinued.
Study treatment may be discontinued if any of the following occurs: confirmed disease progression, unacceptable toxicity, withdrawal of informed consent, inability to comply with the study protocol, receipt of other anticancer therapies that may interfere with study outcomes, or if the investigator determines that continued treatment is no longer in the patient's best interest. However, if radiologic disease progression is observed but the investigator determines that the patient continues to derive clinical benefit, treatment beyond progression may be considered after discussion with the sponsor, with appropriate documentation of the rationale.
After discontinuation of study treatment, patients will receive the most appropriate subsequent management, including best supportive care (BSC) or other anticancer therapies, as determined by the treating investigator. Follow-up assessments will continue according to the study protocol.
The primary objective of this study is to evaluate the efficacy of Belvarafenib in patients with BRAF-altered primary and metastatic brain tumors, while also assessing its safety profile. The results of this study are expected to provide important clinical evidence supporting the development of new treatment strategies for patients with BRAF-altered brain tumors.
Read the detailed description
The purpose of this study is to evaluate the efficacy and safety of Belvarafenib, an oral pan-RAF inhibitor, in patients with BRAF-altered primary brain tumors and BRAF-altered metastatic brain tumors.
The study includes two groups of patients:
Cohort 1: Patients with primary brain tumors harboring BRAF alterations. Cohort 2: Patients with metastatic brain tumors harboring BRAF alterations.
The study will evaluate whether Belvarafenib can:
Reduce or control tumor growth. Delay disease progression. Improve survival outcomes. Demonstrate treatment activity in brain lesions as well as in tumors outside the brain (for patients with metastatic disease).
In addition, the study will assess changes in neurological symptoms, physical function, and overall health-related quality of life using the PROMIS Global Health Scale (PROMIS-GH) to better understand the relationship between treatment response and patients' clinical outcomes.
The results of this study are expected to provide important evidence regarding the potential role of Belvarafenib as a treatment option for patients with BRAF-altered primary and metastatic brain tumors.
- Conditions
- Primary Brain Tumor, Metastatic Brain Tumor
- Being tested
- Belvarafenib
- Keywords
- Belvarafenib, Pan-RAF inhibitor, BRAF alteration, Primary brain tumor, Brain metastases, Central nervous system, Targeted therapy, Precision oncology
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BelvarafenibDrug
Belvarafenib is an oral pan-RAF inhibitor administered at a dose of 450 mg twice daily (BID) in continuous 28-day treatment cycles. Treatment will continue until disease progression, unacceptable toxicity, withdrawal of consent, death, or investigator decision. The study evaluates the efficacy and safety of Belvarafenib in patients with recurrent or refractory BRAF-mutant (including V600E and BRAF fusion mutations) primary brain tumors and metastatic brain tumors.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: Primary Brain Tumors | Experimental | Patients with recurrent or refractory BRAF-mutant (including V600E and BRAF fusion mutations) primary brain tumors will receive Belvarafenib. Receives: Drug: Belvarafenib |
| Cohort 2: Metastatic Brain Tumors | Experimental | Patients with recurrent or refractory BRAF-mutant (including V600E and BRAF fusion mutations) metastatic brain tumors will receive Belvarafenib. Receives: Drug: Belvarafenib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Cohort 1. 6-Month Progression-Free Survival (6m-PFS)
Percentage of participants who remain alive without disease progression at 6 months, assessed according to RANO version 2.0.
Measured: 6 months
Primary Cohort 2. 6-Month Progression-Free Survival
Percentage of participants who remain alive without disease progression at 6 months, assessed according to RANO-BM.
Measured: 6 months
Secondary outcomes (9)
Progression-Free Survival (PFS)
Time from the first dose of Belvarafenib to disease progression or death from any cause.
Measured: Up to 24 months
Overall Survival (OS)
Time from the first dose of Belvarafenib to death from any cause.
Measured: Up to 24 months
Cohort 1: Primary Brain Tumors Confirmed Objective Response Rate (cORR)
Percentage of participants achieving a confirmed complete response (CR) or partial response (PR), assessed according to RANO version 2.0.
Measured: Up to 24 months
Cohort 2: Metastatic Brain Tumors Confirmed Objective Response Rate (cORR)
Percentage of participants achieving a confirmed complete response (CR) or partial response (PR), assessed according to RANO-BM.
Measured: Up to 24 months
Cohort 1: Primary Brain Tumors Duration of Response (DoR)
Time from the first documented complete response (CR) or partial response (PR) until disease progression or death, assessed according to RANO version 2.0.
Measured: Up to 24 months
Cohort 2: Metastatic Brain Tumors Duration of Response (DoR)
Time from the first documented complete response (CR) or partial response (PR) until disease progression or death, assessed according to RANO-BM.
Measured: Up to 24 months
Cohort 1: Primary Brain Tumors Disease Control Rate (DCR)
Percentage of participants achieving complete response (CR), partial response (PR), or stable disease (SD), assessed according to RANO version 2.0.
Measured: Up to 24 months
Cohort 2: Metastatic Brain Tumors Disease Control Rate (DCR)
Percentage of participants achieving complete response (CR), partial response (PR), or stable disease (SD), assessed according to RANO-BM.
Measured: Up to 24 months
Incidence of Treatment-Emergent Adverse Events
Number and percentage of participants experiencing treatment-emergent adverse events graded according to CTCAE version 5.0.
Measured: From first dose until 30 days after the last dose (approximately up to 24 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2026
- Study start15 Jun 2026
- Primary completion30 Jun 2028 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Brain TumorStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- 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
- Parallel groups
- Model description
- Patients with recurrent or refractory BRAF-mutant (including V600E mutations and BRAF fusion mutations) primary brain tumors and metastatic brain tumors will be enrolled into two independent cohorts. Approximately 15 patients per cohort will receive Belvarafenib treatment. No concurrent control group will be included; study outcomes will be compared with published literature and/or real-world data as appropriate.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Hanmi Pharm
- Responsible party
- Principal investigator, Hyun Ae Jung, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07688356
- Sponsor's protocol ID
- 2026-03-119
- Status last verified
- Jul 2026
- First submitted
- 25 Jun 2026
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared because there is no plan for public data sharing under the current study protocol. Data will be used solely for the purposes of this study and managed in accordance with applicable regulations, institutional policies, and participant confidentiality requirements.
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Phase 2 Study for Evaluating CNS Efficacy of Belvarafenib in Patients With BRAF-Altered Solid Tumors
- ClinicalTrials.gov ID
- NCT07688356
- Acronym / sponsor ID
- 2026-03-119
- Conditions
- Primary Brain Tumor, Metastatic Brain Tumor
- Keywords
- Belvarafenib, Pan-RAF inhibitor, BRAF alteration, Primary brain tumor, Brain metastases, Central nervous system, Targeted therapy, Precision oncology
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Collaborators
- Hanmi Pharm
- Study start
- 15 Jun 2026 (actual)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 7 Jul 2026 (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.
This is a Phase 2, open-label, single-arm clinical study designed to evaluate the efficacy and safety of Belvarafenib in patients with BRAF-altered primary brain tumors (Cohort 1) and metastatic brain tumors (Cohort 2). Eligible patients are those with a confirmed BRAF alteration identified by next-generation sequencing (NGS).
Patients who meet the eligibility criteria will receive a detailed explanation of the study, including its purpose, procedures, potential benefits, and risks. Only patients who voluntarily provide written informed consent will be enrolled.
All enrolled patients will receive Belvarafenib monotherapy at a dose of 450 mg twice daily (BID). The study drug will be taken orally within 30 minutes after meals with at least 200 mL of water, preferably at approximately 12-hour intervals each day. One treatment cycle is defined as 28 consecutive days of continuous dosing without a planned treatment break. Patients will receive treatment for six cycles (approximately six months) as the initial treatment period. Treatment may be extended or discontinued earlier at the investigator's discretion based on clinical benefit, disease status, and tolerability.
During the study, patients will undergo regular clinical evaluations, including physical examinations, vital sign assessments, laboratory tests, and monitoring for adverse events. Radiologic assessments using MRI and/or CT will be performed at scheduled intervals to evaluate tumor response and disease progression. The study aims to determine whether Belvarafenib can control tumor growth, delay disease progression, and improve clinical outcomes in patients with BRAF-altered brain tumors.
If treatment-related toxicities occur, dose reductions are permitted according to the protocol. The dose may be reduced from 450 mg BID to 300 mg BID, and subsequently to 200 mg BID, if clinically indicated. Temporary treatment interruption may also be implemented until toxicity resolves. If unacceptable toxicity persists despite dose modification, treatment will be permanently discontinued.
Study treatment may be discontinued if any of the following occurs: confirmed disease progression, unacceptable toxicity, withdrawal of informed consent, inability to comply with the study protocol, receipt of other anticancer therapies that may interfere with study outcomes, or if the investigator determines that continued treatment is no longer in the patient's best interest. However, if radiologic disease progression is observed but the investigator determines that the patient continues to derive clinical benefit, treatment beyond progression may be considered after discussion with the sponsor, with appropriate documentation of the rationale.
After discontinuation of study treatment, patients will receive the most appropriate subsequent management, including best supportive care (BSC) or other anticancer therapies, as determined by the treating investigator. Follow-up assessments will continue according to the study protocol.
The primary objective of this study is to evaluate the efficacy of Belvarafenib in patients with BRAF-altered primary and metastatic brain tumors, while also assessing its safety profile. The results of this study are expected to provide important clinical evidence supporting the development of new treatment strategies for patients with BRAF-altered brain tumors.
Detailed description
The purpose of this study is to evaluate the efficacy and safety of Belvarafenib, an oral pan-RAF inhibitor, in patients with BRAF-altered primary brain tumors and BRAF-altered metastatic brain tumors.
The study includes two groups of patients:
Cohort 1: Patients with primary brain tumors harboring BRAF alterations. Cohort 2: Patients with metastatic brain tumors harboring BRAF alterations.
The study will evaluate whether Belvarafenib can:
Reduce or control tumor growth. Delay disease progression. Improve survival outcomes. Demonstrate treatment activity in brain lesions as well as in tumors outside the brain (for patients with metastatic disease).
In addition, the study will assess changes in neurological symptoms, physical function, and overall health-related quality of life using the PROMIS Global Health Scale (PROMIS-GH) to better understand the relationship between treatment response and patients' clinical outcomes.
The results of this study are expected to provide important evidence regarding the potential role of Belvarafenib as a treatment option for patients with BRAF-altered primary and metastatic brain tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients with recurrent or refractory BRAF-mutant (including V600E mutations and BRAF fusion mutations) primary brain tumors and metastatic brain tumors will be enrolled into two independent cohorts. Approximately 15 patients per cohort will receive Belvarafenib treatment. No concurrent control group will be included; study outcomes will be compared with published literature and/or real-world data as appropriate.
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: Primary Brain Tumors | Experimental | Drug: BelvarafenibPatients with recurrent or refractory BRAF-mutant (including V600E and BRAF fusion mutations) primary brain tumors will receive Belvarafenib. |
| Cohort 2: Metastatic Brain Tumors | Experimental | Drug: BelvarafenibPatients with recurrent or refractory BRAF-mutant (including V600E and BRAF fusion mutations) metastatic brain tumors will receive Belvarafenib. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (33 listed)
- Male or female patients aged 19 years or older.
- Histologically confirmed primary brain tumor or metastatic brain tumor.
- Documented BRAF mutation, including point mutations (e.g., V600E) or BRAF fusion mutations.
- Willing and able to provide written informed consent prior to participation in the study.
- Estimated life expectancy of at least 3 months.
Key exclusion criteria (35 listed)
- History of hypersensitivity to BRAF inhibitors or related compounds. Prior treatment with a BRAF inhibitor is permitted.
- Presence of hematologic malignancy or double primary malignancies at screening. The following second primary malignancies are permitted:
- Any of the following:
- Unresolved adverse events of CTCAE Grade ≥2 from previous anticancer therapy at screening, except alopecia.
- Any of the following cardiovascular conditions:
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 |
|---|---|---|
| BelvarafenibBelvarafenib is an oral pan-RAF inhibitor administered at a dose of 450 mg twice daily (BID) in continuous 28-day treatment cycles. Treatment will continue until disease progression, unacceptable toxicity, withdrawal of consent, death, or investigator decision. The study evaluates the efficacy and safety of Belvarafenib in patients with recurrent or refractory BRAF-mutant (including V600E and BRAF fusion mutations) primary brain tumors and metastatic brain tumors. | Drug | Cohort 1: Primary Brain Tumors, Cohort 2: Metastatic Brain Tumors |
Primary outcome
Primary Cohort 1. 6-Month Progression-Free Survival (6m-PFS)
Time frame: 6 months
Percentage of participants who remain alive without disease progression at 6 months, assessed according to RANO version 2.0.
Primary Cohort 2. 6-Month Progression-Free Survival
Time frame: 6 months
Percentage of participants who remain alive without disease progression at 6 months, assessed according to RANO-BM.
9 secondary outcomes
Progression-Free Survival (PFS)
Time frame: Up to 24 months
Overall Survival (OS)
Time frame: Up to 24 months
Cohort 1: Primary Brain Tumors Confirmed Objective Response Rate (cORR)
Time frame: Up to 24 months
Cohort 2: Metastatic Brain Tumors Confirmed Objective Response Rate (cORR)
Time frame: Up to 24 months
Cohort 1: Primary Brain Tumors Duration of Response (DoR)
Time frame: Up to 24 months
Cohort 2: Metastatic Brain Tumors Duration of Response (DoR)
Time frame: Up to 24 months
Cohort 1: Primary Brain Tumors Disease Control Rate (DCR)
Time frame: Up to 24 months
Cohort 2: Metastatic Brain Tumors Disease Control Rate (DCR)
Time frame: Up to 24 months
Incidence of Treatment-Emergent Adverse Events
Time frame: From first dose until 30 days after the last dose (approximately up to 24 months)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared because there is no plan for public data sharing under the current study protocol. Data will be used solely for the purposes of this study and managed in accordance with applicable regulations, institutional policies, and participant confidentiality requirements.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Belvarafenib in people with Primary Brain Tumor and Metastatic Brain Tumor, run by Samsung Medical Center at 1 site in South Korea.
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 33 inclusion and 35 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: looking for participants now, as of the sponsor's last update on 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hyun Ae Jung, MD, PhD (+82-2-, hyunae0608.jung@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Cohort 1. 6-Month Progression-Free Survival (6m-PFS) (time frame: 6 months). The study lists 2 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 8 Jul 2026.