NBM-BMX Administered Orally to Patients with Solid Tumors or Newly Diagnosed Glioblastoma

Launched by NOVELWISE PHARMACEUTICAL CORPORATION · Aug 22, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new medication called NBM-BMX, which is taken by mouth, to see if it is safe and effective for treating patients with advanced solid tumors or newly diagnosed glioblastoma, a type of brain cancer. NBM-BMX is designed to target specific proteins that cancer cells use to grow. The trial will be looking at how well the drug works on its own and when combined with standard treatments for glioblastoma.

To be eligible for the study, participants must be at least 18 years old and have specific types of cancer that have either not responded to other treatments or for which there are no effective options available. Participants in the trial can expect regular check-ups and tests to monitor their health and how their body is responding to the medication. It’s also important to know that there are certain health conditions and treatments that may exclude someone from participating, such as recent surgeries or other serious medical issues. Overall, this trial aims to find out if NBM-BMX could be a beneficial new option for patients battling these challenging cancers.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Arm A (advanced solid tumors)
• • 1. Having signed and dated the informed consent form.
• • 2. Females or males \> 18 years old.
• • 3. Histologically or cytologically confirmed advanced solid tumors refractory to standard of care therapy, or for which no standard of care therapy is available.
• • 4. 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).
• • 5. Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2.
• 6. Adequate organ function as defined by the following criteria:
• • 1. Serum aspartate transaminase (AST) and serum alanine transaminase (ALT) ≤ 3 × upper limits of normal (ULN), unless liver metastases present, then ≤ 5 × 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/1.73 m2 × BSA (m2)/1.73.
• • Transfusion is not allowed to meet entry criteria.
• • 7. QTcF ≤ 480 msec
• • 8. Willingness and ability to comply with the study scheduled visits, treatment plans, laboratory tests and other procedures.
• • Arm B (newly diagnosed GBM)
• • 1. Having signed and dated the informed consent form.
• • 2. Females or males \> 18 years old.
• • 3. Newly diagnosed, histologically confirmed glioblastoma, non-resectable, partially resected or resected.
• • 4. Karnofsky performance status (KPS) ≥ 60 at screening and before the initiation (Day 1) of concomitant therapy.
• • 5. Disease that is measurable or evaluable as defined by Response Assessment in Neuro-Oncology (RANO) criteria.
• 6. Adequate organ function as defined by the following criteria:
• • 1. Serum aspartate transaminase (AST) and serum alanine transaminase (ALT) ≤ 3 × upper limit of normal (ULN), unless liver metastases present, then ≤ 5 × 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) ≥ 1,500/μL
• • 4. Platelets ≥ 100,000/μL
• • 5. Hemoglobin ≥ 8.0 g/dL
• • 6. 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.
• • 7. QTcF ≤ 480 msec
• • 8. Willingness and ability to comply with the study scheduled visits, treatment plans, laboratory tests and other procedures.
• Exclusion Criteria:
• • Arm A (advanced solid tumors)
• • 1. 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.
• • 2. Curative radiation therapy within 28 days or palliative RT within 7 days of the first dose of NBM-BMX.
• • 3. Currently taking strong inhibitors (e.g., gemfibrozil) or inducers of CYP2C8.
• • 4. 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.
• • 5. 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.
• • 6. Known history of human immunodeficiency virus (HIV) infection.
• • 7. Men and women of childbearing potential who are unwilling to use highly effective contraceptive methods during the study period.
• • Highly effective contraceptive methods include implants, injectables, combined oral contraceptives, intra-uterine devices (IUDs), sexual abstinence, surgical sterilization or a partner who is sterile.
• • 8. Females 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.
• • Arm B (newly diagnosed GBM)
• • 1. Prior systemic therapy (including Gliadel wafer implant), immunotherapy, investigational agents, or radiotherapy for glioblastoma.
• • 2. Currently taking strong inhibitors (e.g., gemfibrozil) or inducers of CYP2C8.
• • 3. Corticosteroid use of \> 8 mg/day dexamethasone or equivalent within 5 days before the first dose of NBM-BMX.
• • 4. A history of hypersensitivity reaction to temozolomide or dacarbazine.
• • 5. 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.
• • 6. 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.
• • 7. Known history of human immunodeficiency virus (HIV) infection. Note: HIV testing is not required.
• • 8. Men and women of childbearing potential who are unwilling to use highly effective contraceptive methods during the study period and for at least 6 months after the final dose of temozolomide.
• • Highly effective contraceptive methods include implants, injectables, combined oral contraceptives, intra-uterine devices (IUDs), sexual abstinence, surgical sterilization or a partner who is sterile.
• • 9. Female who are pregnant or breastfeeding.
• • 10. 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.