NBM-BMX Administered Orally to Patients With Solid Tumors or Newly Diagnosed Glioblastoma
A Phase Ib/II, Open-label Study of NBM-BMX as Monotherapy or in Combination With Radiotherapy and Temozolomide in Subjects With Solid Tumors or Newly Diagnosed Glioblastoma
Sponsor: Novelwise Pharmaceutical Corporation
Listed as NCT06012695, this observational or N/A phase trial focuses on Malignant Neoplasm and Malignant Neoplasm of Brain and remains actively recruiting participants. Sponsored by Novelwise Pharmaceutical Corporation, it has been updated 7 times since 2023, reflecting limited change activity. This study contributes to the evolving evidence base for cancer treatment protocols.
Study Description(click to expand)This is a multi-center, open-label, 2-arm, phase Ib/II study to evaluate the safety, pharmacokinetics, and preliminary efficacy of NBM-BMX as monotherapy in the treatment of solid tumors (Arm A) or in combination with radiotherapy/temozolomide in the treatment of glioblastoma (Arm B).
Arm A consists of dose escalation cohorts in subjects with advanced solid tumors who will be treated with NBM-BMX monotherapy at different dose levels. Arm B consists of dose escalation cohorts (Phase Ib) and expansion cohorts (Phase II) in subjects with newly diagnosed glioblastoma (GBM). Subjects will be treated with NBM-BMX at different dose levels in combination with the first-line standard of care treatment (i.e., concomitant Radiotherapy (RT)/TMZ followed by adjuvant TMZ) in Phase Ib. After the recommended Phase 2 dose (RP2D) is determined in Phase Ib, additional subjects will be enrolled and treated at the RP2D to evaluate the efficacy of NBM-BMX combination therapy.
This is a multi-center, open-label, 2-arm, phase Ib/II study to evaluate the safety, pharmacokinetics, and preliminary efficacy of NBM-BMX as monotherapy in the treatment of solid tumors (Arm A) or in combination with radiotherapy/temozolomide in the treatment of glioblastoma (Arm B).
Arm A consists of dose escalation cohorts in subjects with advanced solid tumors who will be treated with NBM-BMX monotherapy at different dose levels. Arm B consists of dose escalation cohorts (Phase Ib) and expansion cohorts (Phase II) in subjects with newly diagnosed glioblastoma (GBM). Subjects will be treated with NBM-BMX at different dose levels in combination with the first-line standard of care treatment (i.e., concomitant Radiotherapy (RT)/TMZ followed by adjuvant TMZ) in Phase Ib. After the recommended Phase 2 dose (RP2D) is determined in Phase Ib, additional subjects will be enrolled and treated at the RP2D to evaluate the efficacy of NBM-BMX combination therapy.
Status Flow
Change History
7 versions recorded-
May 4, 2026 — Present [daily]
Recruiting
Phase: PHASE1/PHASE2 → None
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Sep 2025 — May 2026 [monthly]
Recruiting PHASE1/PHASE2
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Dec 2024 — Sep 2025 [monthly]
Recruiting PHASE1/PHASE2
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Sep 2024 — Dec 2024 [monthly]
Recruiting PHASE1/PHASE2
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Jul 2024 — Sep 2024 [monthly]
Recruiting PHASE1/PHASE2
Phase: PHASE1_PHASE2 → PHASE1/PHASE2
▶ Show 2 earlier versions
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Apr 2024 — Jul 2024 [monthly]
Recruiting PHASE1_PHASE2
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Sep 2023 — Apr 2024 [monthly]
Recruiting PHASE1_PHASE2
First recorded
Aug 2023
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
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.
Contact Information
- Novelwise Pharmaceutical Corporation
For direct contact, visit the study record on ClinicalTrials.gov .