NBM-BMX Administered Orally to Patients With Solid Tumors or Newly Diagnosed Glioblastoma
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorNovelwise Pharmaceutical Corporation
About this trial
NBM-BMX is an orally available new chemical entity to inhibit histone deacetylases 8 (HDAC8) activity specifically, being developed as a potential anti-cancer therapeutic by NatureWise. This study aims to evaluate the safety, pharmacokinetics, and preliminary efficacy of NBM-BMX as monotherapy in subjects with advanced solid tumors or combination with the standard of care treatment in subjects with newly diagnosed glioblastoma.
Eligibility criteria
Qualifiers
Having signed and dated the informed consent form.
Females or males > 18 years old.
Histologically or cytologically confirmed advanced solid tumors refractory to standard of care therapy, or for which no standard of care therapy is available.
Disease that is measurable or evaluable as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or Response Assessment in Neuro-Oncology (RANO) criteria (for CNS tumors).
Disqualifiers
Systemic anti-cancer treatment (investigational or approved) within 28 days or 5 half-lives of that drug (whichever is shorter) of the first dose of NBM-BMX.
Curative radiation therapy within 28 days or palliative RT within 7 days of the first dose of NBM-BMX.
Currently taking strong inhibitors (e.g., gemfibrozil) or inducers of CYP2C8.
Any of the following within 6 months of the first dose of NBM-BMX: pulmonary embolism events, deep vein thrombosis (DVT) events, myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, congestive heart failure, or cerebrovascular accident including transient ischemic attack.
Trial design
Treatments tested in this trial
- NBM-BMX Capsule
- Temozolomide
- Standard radiotherapy
Treatment groups
79 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov