An Open-label, Phase I Clinical Trial to Assess the Maximum Tolerated Dose (MTD), Safety and Efficacy of BEY1107 in Combination with Temozolomide in Patient with Recurrent or Progressive Glioblastoma Multiforme (GBM)

Trial ID: NCT05769660

Interventional - Phase 1 - Recruiting

This is a Phase 1 study to evaluate the maximum tolerated dose, safety and efficacy of BEY1107 in combination with Temozolomide in Patients with Recurrent or Progressive Glioblastoma Multiforme (GBM)

Conditions

• Glioblastoma Multiforme

Interventions

• BEY1107
• Temozolomide

Eligibility

Inclusion criteria

• 1. Adult males and females aged over 19 years or older at the time of Informed Consent.
• 2. Diagnosed with GBM according to the World Health Organization(WHO) criteria.
• 3. Subjects with progression or recurrence, with no response to the initial standard of care after being confirmed as GBM on histopathology.
• 4. Subjects with 1 or more lesions that are measurable or evaluable according to the Response Assessment in Neuro-Oncology(RANO) criteria.
• 5. Subjects with European Cooperative Oncology Group(ECOG) performance status 0 or 1.
• 6. For Subjects using corticosteroids, those who do not need escalation within at least 2 weeks prior to administration of Investigational Product(IP) and on a stable dose.
• 7. Women of childbearing potential who are not surgically sterile must consent to practice acceptable contraception until 6 months after the end of IP administration and also have the evidence of not being fertile.
• 8 Non-vasectomized men who consent to use an acceptable contraception by one-self and the partner until 3 months after the end of IP administration.
• 9\. Subjects who are fully informed of this trial, voluntarily decide to participate in the trial and provide written consent to comply with requirements for the trial.

Exclusion criteria

• 1. Patients with a history of chemotherapy for treatment of recurrent glioblastoma multiforme after the initial standard of care as of screening.
• 2. Subjects who have not recovered from the toxicity of the prior anticancer therapy.
• 3. Subjects who have past history of major gastrointestinal surgery making oral drug administration impossible or possibly affecting absorption of IP.
• 4. Subjects who had a major surgery requiring general anesthesia within 4 weeks of screening.
• 5. Subjects with a history of other malignancy except adequately treated basal cell carcinoma of the skin or cervical carcinoma in situ, papillary thyroid cancer or early gastric cancer.
• 6. Subjects with a genetic problem(eg. Galactose intolerance).
• 7. Subjects with hypersensitivity to the ingredient(s) or excipient(s) of the investigational product (BEY1107) or temozolomide.
• 8. Subjects with hypersensitivity to dacarbazine (DTIC).
• 9. Subjects who have the cardiovascular disease as of screening.
• 10. Active hepatitis B, C or HIV positive.
• 11. Patients with acute or severe infection.
• 12. Subjects who take a Rifampin, Phenytoin and azole class antifungal drugs in combination.
• 13. Subjects who had been administered other IP within 4 weeks prior to screening.
• 14. Patients with inadequate bone marrow, kidney and liver function.
• 15. Pregnant women, breastfeeding women, or positive findings on the pregnancy test at screening.
• 16. Subjects with life expectancy of less than 12 weeks by the investigator.
• 17. Subjects determined by the investigator to be ineligible for participation in this trial.

Sponsor

BeyondBio Inc.

Source: ClinicalTrials.gov

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