A Study to Evaluate Safety and Efficacy of BEY1107 in Combination with Temozolomide in Patients with Recurrent or Progressive Glioblastoma Multiforme (GBM)

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A Study to Evaluate Safety and Efficacy of BEY1107 in Combination with Temozolomide in Patients with Recurrent or Progressive Glioblastoma Multiforme (GBM)

Study Purpose

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)

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	19 Years and Over
Gender	All

More Inclusion & Exclusion 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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05769660
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 1
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	BeyondBio Inc.
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	Korea, Republic of
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Glioblastoma Multiforme

Additional Details

In Phase 1, patients with recurrent or progressive glioblastoma multiforme who failed with the standard of care will be enrolled at each dose level of BEY1107 in combination with Temozolomide.

Arms & Interventions

Arms

Experimental: BEY1107 + Temozolomide

Administer BEY1107 in combination with Temozolomide, 4-weeks as 1 cycle.

Interventions

Drug: - BEY1107

Administer twice daily, PO, 4-week continuous dose.

Combination Product: - Temozolomide

Administer once daily, PO, 5-day continuous dose, followed by 23-day rest period.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.