Continued NBM-BMX with temozolomide for newly diagnosed glioblastoma

A Rollover Study to Evaluate the Long-Term Safety and Efficacy of NBM-BMX in Combination With Temozolomide in Patients With Newly Diagnosed Glioblastoma Who Completed Study NBM-BMX-003 (the Parent Study)

This rollover option lets people with newly diagnosed glioblastoma who finished the parent study continue NBM-BMX together with temozolomide to see if ongoing treatment is safe and helps control the tumor.

Quick facts

• Phase: PHASE1; PHASE2
• Study type: Interventional
• Enrollment: 15 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Novelwise Pharmaceutical Corporation (industry)
• Locations: 3 sites (Kaohsiung City and 2 other locations)
• Trial ID: NCT07569042 on ClinicalTrials.gov

What this trial studies

This is a multi-center, open-label, single-arm rollover study that provides continued access to NBM-BMX plus temozolomide for participants who completed Arm B of the parent NBM-BMX-003 study. Eligible participants will continue the same doses and schedules used in the parent study, with possible dose escalation for those from dose-escalation cohorts if approved by the Sponsor. Treatment may continue until disease progression, unacceptable toxicity, withdrawal of consent, death, or up to 12 cycles, whichever occurs first. The trial focuses on collecting long-term safety and efficacy data while maintaining continuity of therapy for participants.

Who should consider this trial

Good fit: Ideal candidates are people with histologically confirmed newly diagnosed glioblastoma who completed or are enrolled in Arm B of NBM-BMX-003, have KPS ≥ 60, adequate organ function, and can enroll within 35 days of their last parent-study dose.

Not a fit: Patients with progressive disease on prior therapy, poor performance status (KPS < 60), inadequate organ function, or who cannot enroll within the 35-day window are unlikely to receive benefit from this rollover treatment.

Why it matters

Potential benefit: If successful, continued NBM-BMX plus temozolomide could prolong disease control and possibly extend survival for some patients while monitoring long-term safety.

How similar studies have performed: Other trials combining experimental targeted agents with temozolomide in glioblastoma have shown mixed results, and long-term benefit from NBM-BMX remains unestablished.

Eligibility criteria

Inclusion Criteria:

Participants must meet all of the following criteria to be eligible for the study:

1. 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.
2. Histologically confirmed glioblastoma.
3. Can enroll into this rollover study within 35 days after completing the last dose of NBM-BMX in the parent study.
4. Have signed and dated the informed consent form.
5. Karnofsky performance status (KPS) ≥ 60 at enrollment in this study.
6. Adequate organ functions as defined by the following criteria:

   1. Serum aspartate transaminase (AST) and serum alanine transaminase (ALT) ≤ 3 × upper limit of normal (ULN)
   2. Total serum bilirubin ≤ 1.5 × ULN unless bilirubin elevation is related to Gilbert's Syndrome for which bilirubin ≤ 3 × ULN
   3. Absolute neutrophil count (ANC) ≥ 1,000/µL
   4. Platelets ≥ 75,000/µL
   5. Hemoglobin ≥ 8.0 g/dL
   6. Non-indexed estimated glomerular filtration rate (eGFR) ≥ 50 mL/min
7. Women of childbearing potential must have a negative pregnancy test performed within 14 days before the first dose of this study.
8. 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.

   Acceptable contraceptive methods include implants, injectables, combined oral contraceptives, intra-uterine devices (IUDs), sexual abstinence, surgical sterilization or a partner who is sterile.
9. Willingness and ability to comply with the study scheduled visits, treatment plans, laboratory tests and other procedures.

Exclusion Criteria:

Participants with any of the following will be excluded from the study:

1. Currently receive or plan to receive anti-cancer treatments other than the study drugs including Gliadel wafer implant or tumor treating fields (TTFields).
2. Permanently discontinued from the parent study due to unacceptable toxicity, non-compliance with study procedures, withdrawal of consent, or any other reason.
3. 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.
4. QTcF \> 480 msec
5. Currently taking strong inhibitors (e.g., gemfibrozil) or inducers of CYP2C8.
6. Have known hypersensitivity reaction to temozolomide, dacarbazine or NBM-BMX.
7. Have difficulty swallowing (including those require nasogastric tube) or with impaired absorption of oral medications.
8. Female who are pregnant or breastfeeding.
9. 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.

Where this trial is running

Kaohsiung City and 2 other locations

• Kaohsiung Medical University Chung-Ho Memorial Hospital — Kaohsiung City, Taiwan (NOT_YET_RECRUITING)
• Taichung Veterans General Hospital — Taichung, Taiwan (NOT_YET_RECRUITING)
• Linkou Chang-Gung Memorial Hospital — Taoyuan City, Taiwan (RECRUITING)

Study contacts

• Study coordinator: Chia-Chung Hou, Ph.D.

Conditions: Malignant Neoplasm of Brain