Actively Recruiting
A Study to Evaluate Safety and Efficacy of BEY1107 in Combination with Temozolomide in Patients with Recurrent or Progressive Glioblastoma Multiforme (GBM)
Led by BeyondBio Inc. · Updated on 2025-03-10
12
Participants Needed
1
Research Sites
213 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official 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 at the time of informed consent
- Diagnosed with Glioblastoma Multiforme (GBM) according to WHO criteria
- Have progression or recurrence of GBM after initial standard treatment confirmed by histopathology
- Have one or more lesions that are measurable or evaluable according to RANO criteria
- Have an ECOG performance status of 0 or 1
- If using corticosteroids, have a stable dose without escalation for at least 2 weeks before starting study treatment
- Women of childbearing potential must agree to use acceptable contraception until 6 months after treatment and show evidence of not being fertile
- Non-vasectomized men must agree to use acceptable contraception by themselves and their partners until 3 months after treatment
- Must voluntarily agree to participate and provide written informed consent
You will not qualify if you...
- History of chemotherapy for recurrent glioblastoma after initial standard treatment
- Not recovered from toxicity of prior anticancer therapy
- History of major gastrointestinal surgery preventing oral drug use or absorption
- Major surgery requiring general anesthesia within 4 weeks before screening
- History of other cancers except treated basal cell carcinoma, cervical carcinoma in situ, papillary thyroid cancer, or early gastric cancer
- Genetic disorders such as galactose intolerance
- Allergic to BEY1107, temozolomide, or dacarbazine
- Cardiovascular disease at screening
- Active hepatitis B, hepatitis C, or HIV infection
- Acute or severe infection
- Taking Rifampin, Phenytoin, or azole antifungal drugs
- Use of other investigational products within 4 weeks before screening
- Inadequate bone marrow, kidney, or liver function
- Pregnant or breastfeeding women or positive pregnancy test at screening
- Life expectancy less than 12 weeks
- Deemed ineligible by the investigator
AI-Screening
AI-Powered Screening
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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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