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

Status: Recruiting
Location: See all (5) locations...
Intervention Type: Drug, Radiation
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

∙ Arm A (advanced solid tumors)

• 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).

• Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2.

• Adequate organ function as defined by the following criteria:

‣ Serum aspartate transaminase (AST) and serum alanine transaminase (ALT) ≤ 3 × upper limits of normal (ULN), unless liver metastases present, then ≤ 5 × 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/1.73 m2 × BSA (m2)/1.73.

• Transfusion is not allowed to meet entry criteria.

• QTcF ≤ 480 msec

• Willingness and ability to comply with the study scheduled visits, treatment plans, laboratory tests and other procedures.

∙ Arm B (newly diagnosed GBM)

• Having signed and dated the informed consent form.

• Females or males \> 18 years old.

• Newly diagnosed, histologically confirmed glioblastoma, non-resectable, partially resected or resected.

• Karnofsky performance status (KPS) ≥ 60 at screening and before the initiation (Day 1) of concomitant therapy.

• Disease that is measurable or evaluable as defined by Response Assessment in Neuro-Oncology (RANO) criteria.

• Adequate organ function as defined by the following criteria:

‣ Serum aspartate transaminase (AST) and serum alanine transaminase (ALT) ≤ 3 × upper limit of normal (ULN), unless liver metastases present, then ≤ 5 × 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) ≥ 1,500/μL

⁃ Platelets ≥ 100,000/μL

⁃ Hemoglobin ≥ 8.0 g/dL

⁃ Non-indexed estimated glomerular filtration rate (eGFR) ≥ 60 mL/min/1.73 m2 × BSA (m2)/1.73.

• Transfusion is not allowed to meet entry criteria.

• QTcF ≤ 480 msec

• Willingness and ability to comply with the study scheduled visits, treatment plans, laboratory tests and other procedures.

Locations
Other Locations
Taiwan
Hualien Tzu Chi Hospital
NOT_YET_RECRUITING
Hualien City
Kaohsiung Medical University Chung-Ho Memorial Hospital
NOT_YET_RECRUITING
Kaohsiung City
Taichung Veterans General Hospital
RECRUITING
Taichung
Koo Foundation Sun Yat-Sen Cancer Center
RECRUITING
Taipei
Linkou Chang-Gung Memorial Hospital
RECRUITING
Taoyuan
Contact Information
Primary
Chia-Chung Hou, Ph.D.
alison.hou@naturewise.com.tw
+886 2 26559109
Backup
Karis Chiang
karis.chiang@effpha.com
+886 2 27891060
Time Frame
Start Date: 2023-08-11
Estimated Completion Date: 2029-09-30
Participants
Target number of participants: 79
Treatments
Experimental: monotherapy in advanced solid tumors
Subjects with advanced solid tumors will be treated with NBM-BMX monotherapy at different dose levels depending on the order of their enrollment.
Experimental: combination therapy in newly diagnosed glioblastoma
Subjects with newly diagnosed glioblastoma will be treated with NBM-BMX at different dose levels in combination with the standard of care treatment (concomitant RT/TMZ followed by adjuvant TMZ). In the expansion study, Subjects will be treated with NBM-BMX at the recommended Phase 2 dose (RP2D) in combination with RT/TMZ.
Sponsors
Leads: Novelwise Pharmaceutical Corporation

This content was sourced from clinicaltrials.gov

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