Evaluating BEY1107 with Temozolomide for recurrent glioblastoma

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)

This study is testing a new treatment called BEY1107 combined with Temozolomide to see if it can help adults with recurrent glioblastoma who haven't had success with standard therapies.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Ages: 19 Years and up
• Sex: All
• Sponsor: BeyondBio Inc. (Industry-sponsored)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Seoul)
• Trial ID: NCT05769660 on ClinicalTrials.gov

What this trial studies

This Phase 1 study aims to determine the maximum tolerated dose, safety, and efficacy of BEY1107 when combined with Temozolomide in patients suffering from recurrent or progressive glioblastoma multiforme (GBM). Participants will be adults who have not responded to standard treatments and will be enrolled at various dose levels of BEY1107. The study will assess the treatment's effects on measurable lesions according to established criteria. The goal is to find a potentially effective new treatment option for this challenging condition.

Who should consider this trial

Good fit: Ideal candidates are adults over 19 years old with recurrent or progressive GBM who have not responded to standard care.

Not a fit: Patients with stable GBM who have not progressed or those who have not failed standard treatments may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with recurrent glioblastoma multiforme who have limited choices.

How similar studies have performed: Other studies have explored similar combinations for GBM, but the specific approach of BEY1107 with Temozolomide is novel.

Eligibility criteria

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.

Where this trial is running

Seoul

• Seoul National University Hospital — Seoul, South Korea (Recruiting)

Conditions Glioblastoma Multiforme; GBM