IN10018 in Combination With Dalpiciclib for Progressive Meningiomas
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorCapital Medical University
About this trial
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 will be taken once daily throughout each cycle, and dalpiciclib will be taken once daily for 21 days followed by 7 days without dalpiciclib. 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.
Eligibility criteria
Qualifiers
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.
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.
Disqualifiers
Left ventricular ejection fraction below 50%;
Corrected QT interval greater than 480 milliseconds;
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.
Trial design
Treatments tested in this trial
- Ifebemtinib
- Dalpiciclib
Treatment groups
24 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov