A Rollover Study of NBM-BMX in Combination With Temozolomide in Patients With Newly Diagnosed Glioblastoma

NCT07569042 | Recruiting Phase 1 FDA Drug

• 1 other identifier: NBM-BMX-005
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 3

Brief Summary

This clinical trial is a rollover study designed to provide continued access to NBM-BMX and temozolomide (TMZ) for eligible participants with newly diagnosed glioblastoma who have completed the designated treatment in Study NBM-BMX-003 (the parent study), and to evaluate the long-term safety and efficacy of NBM-BMX administered in combination with TMZ.

Conditions

Malignant Neoplasm of Brain

Outcome Measures

Primary Outcomes (2)

• Frequency, types, severity, and relationship to NBM-BMX of adverse events (AEs)

  To evaluate the long-term safety and tolerability of NBM-BMX in combination with temozolomide.

  Through study completion, an average of 1 year.

• Progression-free survival (PFS) and overall survival (OS)

  To assess the preliminary long-term efficacy of the combination therapy.

  Through study completion, an average of 1 year.

Study Arms (1)

Combination therapy in glioblastoma

EXPERIMENTAL

Subjects with newly diagnosed glioblastoma who have completed Study NBM-BMX-003 will transition into this study to continue receiving study drugs (NBM-BMX and temozolomide) at the same doses and schedules as in the parent study.

Drug: NBM-BMX Capsule; Drug: Temozolomide

Interventions

NBM-BMX Capsule DRUG

Each capsule contains 100 mg of the active ingredient.

Combination therapy in glioblastoma

Temozolomide DRUG

Temodal 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.

Also known as: TMZ

Combination therapy in glioblastoma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must meet all of the following criteria to be eligible for the study:
• Have completed or currently enrolled in Arm B of Study NBM-BMX-003 (the parent study), and in the opinion of the Investigator, may derive clinical benefit from continued treatment with study drugs.
• Histologically confirmed glioblastoma.
• Can enroll into this rollover study within 35 days after completing the last dose of NBM-BMX in the parent study.
• Have signed and dated the informed consent form.
• Karnofsky performance status (KPS) ≥ 60 at enrollment in this study.
• Adequate organ functions as defined by the following criteria:
• Serum aspartate transaminase (AST) and serum alanine transaminase (ALT) ≤ 3 × upper limit of normal (ULN)
• Total serum bilirubin ≤ 1.5 × ULN unless bilirubin elevation is related to Gilbert's Syndrome for which bilirubin ≤ 3 × ULN
• Absolute neutrophil count (ANC) ≥ 1,000/µL
• Platelets ≥ 75,000/µL
• Hemoglobin ≥ 8.0 g/dL
• Non-indexed estimated glomerular filtration rate (eGFR) ≥ 50 mL/min
• Women of childbearing potential must have a negative pregnancy test performed within 14 days before the first dose of this study.
• Men and women of childbearing potential must agree to use acceptable contraceptive methods throughout the study period and for at least 6 months after the final dose of temozolomide.

You may not qualify if:

• Participants with any of the following will be excluded from the study:
• Currently receive or plan to receive anti-cancer treatments other than the study drugs including Gliadel wafer implant or tumor treating fields (TTFields).
• Permanently discontinued from the parent study due to unacceptable toxicity, non-compliance with study procedures, withdrawal of consent, or any other reason.
• A positive test for hepatitis B (HBsAg) and/or hepatitis C (anti-HCV antibody), unless the HBV DNA level and/or HCV RNA level is below the limit of detection.
• QTcF \> 480 msec
• Currently taking strong inhibitors (e.g., gemfibrozil) or inducers of CYP2C8.
• Have known hypersensitivity reaction to temozolomide, dacarbazine or NBM-BMX.
• Have difficulty swallowing (including those require nasogastric tube) or with impaired absorption of oral medications.
• Female who are pregnant or breastfeeding.
• Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that would impart, in the judgement of the Investigator and/or sponsor, excess risks associated with study participation or study drug administration.

Sponsors & Collaborators

• Novelwise Pharmaceutical Corporation: lead

Study Sites (3)

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, 807, Taiwan

NOT YET RECRUITING

Taichung Veterans General Hospital

Taichung, 407, Taiwan

NOT YET RECRUITING

Linkou Chang-Gung Memorial Hospital

Taoyuan City, 333, Taiwan

RECRUITING

MeSH Terms

Conditions

Brain Neoplasms

Interventions

Temozolomide

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Dacarbazine; Triazenes; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Chia-Chung Hou, Ph.D.

CONTACT

886 2 26559109; alison.hou@novelwisepharma.com

Cherry Hsu

CONTACT

886 2 27891060; cherry.hsu@effpha.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2026
• First Posted: May 6, 2026
• Study Start: April 20, 2026
• Primary Completion (Estimated): September 30, 2029
• Study Completion (Estimated): December 31, 2030
• Last Updated: May 6, 2026

Record last verified: 2026-05

Locations

TW (3)