MeningiomaPhase 1NCT07652762
IN10018 in Combination With Dalpiciclib for Progressive Meningiomas
A Phase 1 study testing Ifebemtinib and Dalpiciclib in people with Meningioma and CDK4/6 Inhibitor, run by Capital Medical University at 2 sites in China.
Trial summary
This open-label Phase Ib study will evaluate the safety, tolerability, and preliminary effectiveness of IN10018 in combination with dalpiciclib in adults with progressive meningiomas. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Meningioma, CDK4/6 Inhibitor
- What is being tested?
- Ifebemtinib and Dalpiciclib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 2 sitesChina
- Study dates
- 31 Aug 2026to Aug 2029
- Phase
- Phase 1
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must be able to understand and willing to sign a written informed consent form and agree to comply with all study requirements. Written informed consent must be obtained before any study-related examination or procedure is performed.
- Aged 18 years or older, male or female.
- Histologically confirmed meningioma meeting at least one of the following conditions:
- World Health Organization (WHO) Grade 2 or Grade 3 meningioma; or
- WHO Grade 1 meningioma that has recurred after surgery or radiotherapy and demonstrates clear radiographic or clinical progression, as determined by the investigator.
- No available standard treatment option, or failure of standard treatment, including surgery, radiotherapy, or other systemic therapy.
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- At least 24 weeks must have elapsed since completion of radiotherapy, including external beam radiation therapy, brachytherapy, or radiosurgery such as Gamma Knife or CyberKnife.
- At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1), as confirmed by the investigator.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2. Estimated life expectancy of at least 3 months, as determined by the investigator.
- Adverse effects caused by previous treatments must have recovered to Grade 1 or lower according to the Common Terminology Criteria for Adverse Events (CTCAE), except for alopecia and fatigue.
- The dose of corticosteroids or other hormonal treatment must have been stable for at least 4 days before enrollment.
- Adequate hematologic and organ function, based on laboratory tests performed within 7 days before the first dose, as follows:
- Hematologic function:
- Hemoglobin of at least 100 g/L, without dependence on red blood cell transfusion or erythropoietin.
- Platelet count of at least 100 × 10^9/L, without dependence on platelet transfusion.
- Absolute neutrophil count of at least 1.5 × 10^9/L, without the use of colony-stimulating factors.
- Hepatic function:
- Total bilirubin no greater than the upper limit of normal.
- Alanine aminotransferase and aspartate aminotransferase no greater than 2.5 times the upper limit of normal.
- Renal function:
- Serum creatinine no greater than 1.5 times the upper limit of normal.
- Either creatinine clearance calculated using the Cockcroft-Gault formula of at least 60 mL/min or estimated glomerular filtration rate calculated using the Modification of Diet in Renal Disease formula of at least 60 mL/min/1.73 m².
- Urinary protein and coagulation function:
- Urine protein negative or trace. Participants with urine protein of 1+ must have a morning spot urine protein-to-creatinine ratio of less than 0.5 or 24-hour urinary protein of less than 0.5 g/24 hours.
- International normalized ratio no greater than 1.5 and activated partial thromboplastin time no greater than 1.5 times the upper limit of normal.
- Female participants must not be pregnant or breastfeeding and must meet one of the following conditions:
- Not be a woman of childbearing potential; or
- If a woman of childbearing potential, agree to follow the protocol-specified contraceptive requirements during study treatment and for 3 months after the last dose.
Who cannot join
- Major surgery or major trauma within 28 days before the first dose, or diagnostic biopsy within 14 days before the first dose.
- Receipt of systemic anticancer treatment, including an investigational drug, within the protocol-specified washout period, including chemotherapy or targeted therapy within 14 days or 5 half-lives before the first dose, whichever is shorter, or immunotherapy within 28 days before the first dose.
- Previous treatment with a focal adhesion kinase inhibitor or a cyclin-dependent kinase 4/6 inhibitor, including dalpiciclib.
- A serious cardiovascular event or clinically significant cardiovascular condition within 6 months before initiation of study treatment, including but not limited to:
- Left ventricular ejection fraction below 50%;
- Corrected QT interval greater than 480 milliseconds;
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- New York Heart Association functional class 2 or higher;
- History of serious arrhythmia or cardiomyopathy. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage. Participants with small-volume effusions detectable only by imaging may be considered eligible.
- Malabsorption syndrome or inability to take oral medication. Serious gastrointestinal disease, including uncontrolled inflammatory gastrointestinal disease, active Crohn disease, active ulcerative colitis, or uncontrolled gastrointestinal bleeding.
- Active infection that is not adequately controlled by systemic treatment. Known human immunodeficiency virus infection. Human immunodeficiency virus testing is not required during screening unless mandated by local regulations or institutional policy.
- Known active hepatitis B virus or hepatitis C virus infection. Hepatitis B virus and hepatitis C virus testing is not required during screening unless mandated by local regulations or institutional policy.
- Any medical history, treatment, laboratory abnormality, or other condition that, in the investigator's judgment, could confound interpretation of the study results, interfere with participant compliance, or compromise the participant's safety or interests.
- Known psychiatric illness or substance abuse that could interfere with compliance with study requirements.
- Known hypersensitivity to IN10018, dalpiciclib, or any component of either study drug.
- Systemic treatment with a strong inhibitor or inducer of CYP3A4, CYP2D6, or P-glycoprotein within 14 days before the first dose, or anticipated need for such treatment during the study treatment period.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Beijing Sanbo Brain Hospital, Capital Medical University
Beijing, Beijing Municipality, 100093
Research Secretary, +86 18701200112, 18600884984@163.com
- Not yet recruiting
Sanbo Brain Hospital, Capital Medical University
Beijing
About this study
Official title: An Open-Label Phase Ib Clinical Study Evaluating the Safety, Tolerability, and Efficacy of IN10018 in Combination With Dalpiciclib in Participants With Progressive Meningiomas
This open-label Phase Ib study will evaluate the safety, tolerability, and preliminary effectiveness of IN10018 in combination with dalpiciclib in adults with progressive meningiomas. Progressive meningiomas are tumors arising from the membranes surrounding the brain that have continued to grow or have returned after previous treatment.
Participants will receive both study drugs by mouth in 28-day treatment cycles. IN10018 and dalpiciclib will each be taken once daily for 21 days, followed by 7 days off in each 28-day cycle. Treatment may continue until the tumor progresses, unacceptable side effects occur, or another reason for stopping treatment applies.
The study includes a dose-confirmation phase and a dose-expansion phase. The main goals are to evaluate side effects and determine a recommended dose of the combination for further study. Researchers will also assess whether the treatment can shrink tumors or delay tumor growth, measure how the drugs are processed in the body, and explore tumor and blood biomarkers that may be associated with treatment response.
- Conditions
- Meningioma, CDK4/6 Inhibitor
- Being tested
- Ifebemtinib, Dalpiciclib
- Medical subject headings
- Meningioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IfebemtinibDrug
Ifebemtinib (IN10018) is an investigational oral focal adhesion kinase inhibitor. It will be administered at a starting dose of 100 mg once daily on Days 1 through 21 of each 28-day treatment cycle, followed by 7 days without IN10018. If the starting dose is not tolerated, the dose may be reduced to 50 mg once daily. Ifebemtinib will be administered in combination with dalpiciclib until disease progression, unacceptable toxicity, withdrawal of consent, or another protocol-defined discontinuation criterion.
DalpiciclibDrug
Dalpiciclib is an oral, selective cyclin-dependent kinase 4 and 6 inhibitor. It will be administered at a starting dose of 125 mg once daily on Days 1 through 21 of each 28-day treatment cycle, followed by 7 days without dalpiciclib. If the starting dose is not tolerated, the dose may be reduced to 100 mg once daily. Dalpiciclib will be administered in combination with ifebemtinib until disease progression, unacceptable toxicity, withdrawal of consent, or another protocol-defined discontinuation criterion.
| Study group | Role | What they receive |
|---|---|---|
| IN10018 Plus Dalpiciclib | Experimental | Participants will receive oral IN10018 in combination with oral dalpiciclib in 28-day treatment cycles. IN10018 will be administered once daily at 100 mg on Days 1 through 21 of each cycle, followed by 7 days off treatment, with a permitted reduced dose of 50 mg. Dalpiciclib will be administered once daily at 125 mg on Days 1 through 21 of each cycle, followed by 7 days off treatment, with a permitted reduced dose of 100 mg. A modified 3+3 design will be used during dose confirmation to determine the recommended dose. Participants enrolled in the dose-expansion phase will receive the combination at the recommended dose. Treatment will continue until disease progression, unacceptable toxicity, withdrawal of consent, or another protocol-defined discontinuation criterion. Receives: Drug: Ifebemtinib; Drug: Dalpiciclib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Dose-Limiting Toxicities (DLTs)
The number and percentage of participants who experience at least one protocol-defined dose-limiting toxicity during Cycle 1. Dose-limiting toxicities will be assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0, and must be considered related to IN10018 and/or dalpiciclib.
Measured: Dose-limiting toxicities will be assessed at the end of Cycle 1 (each cycle is 28 days).
Incidence of Treatment-Emergent Adverse Events
Number and percentage of participants who experience treatment-emergent adverse events, treatment-related adverse events, serious adverse events, Grade 3 or higher adverse events, or adverse events resulting in treatment interruption, dose reduction, or permanent treatment discontinuation. Adverse events will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), version 5.0.
Measured: Adverse events will be assessed from the first dose through 30 days after the last dose of study treatment, up to approximately 24 months.
Secondary outcomes (6)
Objective Response Rate (ORR)
Percentage of participants with a best overall response of complete response or partial response according to RANO for Meningioma.
Measured: From first dose until disease progression, initiation of new anticancer therapy, withdrawal, death, or study completion, up to 36 months.
Six-Month Progression-Free Survival Rate (PFS-6)
Percentage of participants alive without radiographic disease progression at 6 months after the first dose of study treatment.
Measured: At 6 months after the first dose.
Disease Control Rate (DCR)
Percentage of participants achieving CR, PR, minor response (MR), or stable disease (SD) lasting at least 8 weeks.
Measured: From first dose until disease progression, withdrawal, death, or study completion, up to 36 months.
Duration of Response (DoR)
Time from the first documented objective response (CR or PR) until disease progression or death from any cause.
Measured: From first documented response until disease progression or death, up to 36 months.
Progression-Free Survival (PFS)
Time from the first dose of study treatment until radiographic disease progression according to RANO criteria or death from any cause.
Measured: From first dose until disease progression or death, up to 36 months.
Overall Survival (OS)
Time from the first dose of study treatment until death from any cause.
Measured: From first dose until death from any cause, up to 36 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2026
- Study start31 Aug 2026
- Primary completionAug 2028 (estimated)
- Study completionAug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MeningiomaStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Capital Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hongwei Zhang, Capital Medical University
- Investigators
- Hongwei Zhang, MD, PhD, Principal investigator, Beijing Sanbo Brain Hospital, Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07652762
- Sponsor's protocol ID
- CMU-MEN-IN10018-DAL-IB-001
- Status last verified
- Oct 2026
- First submitted
- 5 Jun 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Phase Ib Clinical Study Evaluating the Safety, Tolerability, and Efficacy of IN10018 in Combination With Dalpiciclib in Participants With Progressive Meningiomas
- ClinicalTrials.gov ID
- NCT07652762
- Acronym / sponsor ID
- CMU-MEN-IN10018-DAL-IB-001
- Conditions
- Meningioma, CDK4/6 Inhibitor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Capital Medical UniversityUniversity, hospital or other
- Study start
- 31 Aug 2026 (actual)
- Primary completion
- Aug 2028 (estimated)
- Study completion
- Aug 2029 (estimated)
- First posted
- 17 Jun 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 open-label Phase Ib study will evaluate the safety, tolerability, and preliminary effectiveness of IN10018 in combination with dalpiciclib in adults with progressive meningiomas. Progressive meningiomas are tumors arising from the membranes surrounding the brain that have continued to grow or have returned after previous treatment.
Participants will receive both study drugs by mouth in 28-day treatment cycles. IN10018 and dalpiciclib will each be taken once daily for 21 days, followed by 7 days off in each 28-day cycle. Treatment may continue until the tumor progresses, unacceptable side effects occur, or another reason for stopping treatment applies.
The study includes a dose-confirmation phase and a dose-expansion phase. The main goals are to evaluate side effects and determine a recommended dose of the combination for further study. Researchers will also assess whether the treatment can shrink tumors or delay tumor growth, measure how the drugs are processed in the body, and explore tumor and blood biomarkers that may be associated with treatment response.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IN10018 Plus Dalpiciclib | Experimental | Drug: Ifebemtinib, Drug: DalpiciclibParticipants will receive oral IN10018 in combination with oral dalpiciclib in 28-day treatment cycles. IN10018 will be administered once daily at 100 mg on Days 1 through 21 of each cycle, followed by 7 days off treatment, with a permitted reduced dose of 50 mg. Dalpiciclib will be administered once daily at 125 mg on Days 1 through 21 of each cycle, followed by 7 days off treatment, with a permitted reduced dose of 100 mg. A modified 3+3 design will be used during dose confirmation to determine the recommended dose. Participants enrolled in the dose-expansion phase will receive the combination at the recommended dose. Treatment will continue until disease progression, unacceptable toxicity, withdrawal of consent, or another protocol-defined discontinuation criterion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (28 listed)
- Participants must be able to understand and willing to sign a written informed consent form and agree to comply with all study requirements. Written informed consent must be obtained before any study-related examination or procedure is performed.
- Aged 18 years or older, male or female.
- World Health Organization (WHO) Grade 2 or Grade 3 meningioma; or
- WHO Grade 1 meningioma that has recurred after surgery or radiotherapy and demonstrates clear radiographic or clinical progression, as determined by the investigator.
- No available standard treatment option, or failure of standard treatment, including surgery, radiotherapy, or other systemic therapy.
Key exclusion criteria (15 listed)
- Major surgery or major trauma within 28 days before the first dose, or diagnostic biopsy within 14 days before the first dose.
- Receipt of systemic anticancer treatment, including an investigational drug, within the protocol-specified washout period, including chemotherapy or targeted therapy within 14 days or 5 half-lives before the first dose, whichever is shorter, or immunotherapy within 28 days before the first dose.
- Previous treatment with a focal adhesion kinase inhibitor or a cyclin-dependent kinase 4/6 inhibitor, including dalpiciclib.
- A serious cardiovascular event or clinically significant cardiovascular condition within 6 months before initiation of study treatment, including but not limited to:
- Left ventricular ejection fraction below 50%;
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 |
|---|---|---|
| IfebemtinibIfebemtinib (IN10018) is an investigational oral focal adhesion kinase inhibitor. It will be administered at a starting dose of 100 mg once daily on Days 1 through 21 of each 28-day treatment cycle, followed by 7 days without IN10018. If the starting dose is not tolerated, the dose may be reduced to 50 mg once daily. Ifebemtinib will be administered in combination with dalpiciclib until disease progression, unacceptable toxicity, withdrawal of consent, or another protocol-defined discontinuation criterion. | Drug | IN10018 Plus Dalpiciclib |
| DalpiciclibDalpiciclib is an oral, selective cyclin-dependent kinase 4 and 6 inhibitor. It will be administered at a starting dose of 125 mg once daily on Days 1 through 21 of each 28-day treatment cycle, followed by 7 days without dalpiciclib. If the starting dose is not tolerated, the dose may be reduced to 100 mg once daily. Dalpiciclib will be administered in combination with ifebemtinib until disease progression, unacceptable toxicity, withdrawal of consent, or another protocol-defined discontinuation criterion. | Drug | IN10018 Plus Dalpiciclib |
Primary outcome
Incidence of Dose-Limiting Toxicities (DLTs)
Time frame: Dose-limiting toxicities will be assessed at the end of Cycle 1 (each cycle is 28 days).
The number and percentage of participants who experience at least one protocol-defined dose-limiting toxicity during Cycle 1. Dose-limiting toxicities will be assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0, and must be considered related to IN10018 and/or dalpiciclib.
Incidence of Treatment-Emergent Adverse Events
Time frame: Adverse events will be assessed from the first dose through 30 days after the last dose of study treatment, up to approximately 24 months.
Number and percentage of participants who experience treatment-emergent adverse events, treatment-related adverse events, serious adverse events, Grade 3 or higher adverse events, or adverse events resulting in treatment interruption, dose reduction, or permanent treatment discontinuation. Adverse events will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), version 5.0.
6 secondary outcomes
Objective Response Rate (ORR)
Time frame: From first dose until disease progression, initiation of new anticancer therapy, withdrawal, death, or study completion, up to 36 months.
Six-Month Progression-Free Survival Rate (PFS-6)
Time frame: At 6 months after the first dose.
Disease Control Rate (DCR)
Time frame: From first dose until disease progression, withdrawal, death, or study completion, up to 36 months.
Duration of Response (DoR)
Time frame: From first documented response until disease progression or death, up to 36 months.
Progression-Free Survival (PFS)
Time frame: From first dose until disease progression or death, up to 36 months.
Overall Survival (OS)
Time frame: From first dose until death from any cause, up to 36 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 21 Oct 2026.
- 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.
Hongwei Zhang, MD, PhD principal investigator
Beijing Sanbo Brain Hospital, Capital Medical University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ifebemtinib and Dalpiciclib in people with Meningioma and CDK4/6 Inhibitor, run by Capital Medical University at 2 sites in China.
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 28 inclusion and 15 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 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Research Secretary (+86 18701200112, 503071697@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Dose-Limiting Toxicities (DLTs) (time frame: Dose-limiting toxicities will be assessed at the end of Cycle 1 (each cycle is 28 days).). 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 21 Oct 2026.