Actively Recruiting
An Open-label Phase 1 Trial to Assess Safety and Maximum Tolerated Dose of BEY1107 Combined with Temozolomide in Adults with Recurrent or Progressive Glioblastoma Multiforme
Led by BeyondBio Inc. · Updated on 2025-03-10
12
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the safety and highest tolerated dose of BEY1107 combined with Temozolomide in adults who have recurrent or progressive glioblastoma multiforme (GBM), a type of brain cancer that has not responded to standard treatments. This Phase 1 trial aims to find the best dose to use in future studies and assess how well the combination works. Participants must have measurable brain lesions and meet certain health criteria to join. Participants will receive BEY1107 taken twice daily by mouth continuously for 4 weeks alongside Temozolomide taken once daily by mouth for 5 days followed by a 23-day rest period. Each 4-week period is considered one treatment cycle. The trial is open-label, so all participants will receive this combination treatment while researchers monitor safety and dosing. During the study, participants will undergo various assessments including scans to measure tumor response, evaluations of side effects, and blood tests to understand drug levels in the body. Researchers will track outcomes such as the maximum tolerated dose, recommended dose for future trials, disease control rate, and progression-free survival over time. The total observation period may last up to 48 weeks or until disease progression. Safety and treatment effects will be closely monitored throughout.
CONDITIONS
Brief Title
A Study to Evaluate Safety and Efficacy of BEY1107 in Combination with Temozolomide in Patients with Recurrent or Progressive Glioblastoma Multiforme (GBM)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 19 years or older
- Diagnosed with glioblastoma multiforme according to WHO criteria
- Recurrence or progression after initial standard treatment confirmed by histopathology
- At least one measurable or evaluable lesion by RANO criteria
- ECOG performance status of 0 or 1
- Stable corticosteroid dose for at least 2 weeks prior to treatment if applicable
- Women of childbearing potential must agree to use contraception until 6 months after treatment and demonstrate infertility
- Non-vasectomized men must agree to use contraception until 3 months after treatment
- Able and willing to provide informed consent and comply with trial requirements
You will not qualify if you...
- Prior chemotherapy for recurrent glioblastoma after initial standard care
- Not recovered from toxicity of previous anticancer treatment
- History of major gastrointestinal surgery affecting oral drug absorption
- Major surgery requiring general anesthesia within 4 weeks before screening
- History of other malignancies except certain treated skin, thyroid, or gastric cancers
- Genetic disorders such as galactose intolerance
- Hypersensitivity to BEY1107, temozolomide, or dacarbazine
- Cardiovascular disease at screening
- Active hepatitis B, C, or HIV infection
- Acute or severe infections
- Use of rifampin, phenytoin, or azole antifungal drugs
- Treatment with other investigational products within 4 weeks prior to screening
- Inadequate bone marrow, kidney, or liver function
- Pregnant or breastfeeding women or positive pregnancy test
- Life expectancy less than 12 weeks
- Any condition making the participant unsuitable as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 4-week cycles until disease progression or discontinuation
Participants receive BEY1107 twice daily and Temozolomide once daily for 5 days followed by 23 days rest, repeated as 4-week cycles.
Visits occur regularly during each 4-week cycle
Trial Site Locations
Total: 1 location
1
Seoul National University Hospital
Seoul, South Korea
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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