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Tests treatment safety and results for Glioblastoma Multiforme
Official title A Study to Evaluate Safety and Efficacy of BEY1107 in Combination with Temozolomide in Patients with Recurrent or Progressive Glioblastoma Multiforme (GBM)
ClinicalTrials.gov ID: NCT05769660
What this study is testing
What is BEY1107?
BEY1107 is an investigational medicine, given as an once-daily, being studied as a potential treatment for glioblastoma multiforme.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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)
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 19 and older
You may be able to join if
- Adult males and females aged over 19 years or older at the time of Informed Consent.
- Diagnosed with GBM according to the World Health Organization(WHO) criteria.
- people with progression or recurrence, with no response to the initial standard of care after being confirmed as GBM on histopathology.
- people with 1 or more lesions that are measurable or evaluable according to the Response Assessment in Neuro-Oncology(RANO) criteria.
- people with European Cooperative Oncology Group(ECOG) performance status 0 or 1.
You likely can't join if
- Patients with a history of chemotherapy for treatment of recurrent glioblastoma multiforme after the initial standard of care as of screening.
- people who have not recovered from the toxicity of the prior anticancer therapy.
- people who have past history of major gastrointestinal surgery making oral drug administration impossible or possibly affecting absorption of IP.
- people who had a major surgery requiring general anesthesia within 4 weeks of screening.
- people with a history of other malignancy except adequately treated basal cell carcinoma of the skin or cervical carcinoma in situ, papillary thyroid...
- people with a genetic problem(eg. Galactose intolerance).
See the full eligibility criteria
- Adult males and females aged over 19 years or older at the time of Informed Consent.
- Diagnosed with GBM according to the World Health Organization(WHO) criteria.
- people with progression or recurrence, with no response to the initial standard of care after being confirmed as GBM on histopathology.
- people with 1 or more lesions that are measurable or evaluable according to the Response Assessment in Neuro-Oncology(RANO) criteria.
- people with European Cooperative Oncology Group(ECOG) performance status 0 or 1.
- For people 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.
- 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...
- Patients with a history of chemotherapy for treatment of recurrent glioblastoma multiforme after the initial standard of care as of screening.
- people who have not recovered from the toxicity of the prior anticancer therapy.
- people who have past history of major gastrointestinal surgery making oral drug administration impossible or possibly affecting absorption of IP.
- people who had a major surgery requiring general anesthesia within 4 weeks of screening.
- people 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.
- people with a genetic problem(eg. Galactose intolerance).
- people with hypersensitivity to the ingredient(s) or excipient(s) of the investigational product (BEY1107) or temozolomide.
- people with hypersensitivity to dacarbazine (DTIC).
- people who have the cardiovascular disease as of screening.
- Active hepatitis B, C or HIV positive.
- Patients with acute or severe infection.
- people who take a Rifampin, Phenytoin and azole class antifungal drugs in combination.
- people who had been administered other IP within 4 weeks prior to screening.
- Patients with inadequate bone marrow, kidney and liver function.
- Pregnant women, breastfeeding women, or positive findings on the pregnancy test at screening.
- people with life expectancy of less than 12 weeks by the investigator.
- people determined by the investigator to be ineligible for participation in this trial.
The study team makes the final eligibility decision.
Where it's taking place
- Seoul, South Korea
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 19 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Seoul, South Korea. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.