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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
NBM-BMX Capsule
DrugEach capsule contains 100 mg of the active ingredient.
Temozolomide
DrugTMZ will be administered orally at a 75 mg/m2 dose daily during concomitant therapy. In the maintenance period, days 1-5 of each cycle will be administered 150-200 mg/m2.
Standard radiotherapy
RadiationA total dose of 60 Gy will be administered in 6 weeks.
Treatment groups
79 Participants
are divided into 2 treatment groupsGroup A: monotherapy in advanced solid tumorsExperimental treatment 1 intervention
Group B: combination therapy in newly diagnosed glioblastomaExperimental treatment 3 interventions
Trial outcomes
Primary outcomes
1
[Arm A, Phase Ib] Frequency of dose-limiting toxicity (DLT) at each dose level
To determine the maximum tolerated dose (MTD) for NBM-BMX monotherapy in subjects with advanced solid tumors, toxicities will be graded according to the National Cancer Institute Common Terminology.
Time frame
up to 28 days2
[Arm B, Phase Ib] Frequency of dose-limiting toxicity (DLT) at each dose level
To determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) for NBM-BMX in combination with RT and TMZ in subjects with newly diagnosed GBM, toxicities will be graded according to the National Cancer Institute Common Terminology.
Time frame
up to 10 weeks3
[Arm B, Phase II] Progression-free survival rate at 6 months (PFS6)
To assess the preliminary efficacy of NBM-BMX in combination with RT and TMZ in subjects with newly diagnosed GBM, the investigators will evaluate anti-tumor activity using RANO criteria.
Time frame
up to 6 monthsSecondary outcomes
1
Frequency, types, severity, and relationship to NBM-BMX of adverse events (AEs)
The severity of AEs will be graded using NCI CTCAE Version 5.0 by the investigator.
Time frame
up to 28 days2
Preliminary assessment of anti-tumor activity by response evaluation criteria
Tumor response and progression will be assessed using the RECIST v1.1 or Response Assessment in Neuro-Oncology (RANO) criteria.
Time frame
at least 8 weeks3
Area under the plasma concentration versus time curve (AUC) of NBM-BMX
Blood samples will be collected at each pre-specified time point for measuring concentrations of NBM-BMX in plasma using a validated bioanalytical method.
Time frame
Day 1, 8 and 15 for Cycle 1 only (each cycle is 28 days)4
Peak plasma concentration (Cmax) of NBM-BMX
Blood samples will be collected at each pre-specified time point for measuring concentrations of NBM-BMX in plasma using a validated bioanalytical method.
Time frame
Day 1, 8 and 15 for Cycle 1 only (each cycle is 28 days)Sponsors and contacts
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Source ClinicalTrials.gov