Glioblastoma MultiformePhase 1NCT05769660
A Study to Evaluate Safety and Efficacy of BEY1107 in Combination with Temozolomide in Patients with Recurrent or Progressive Glioblastoma Multiforme (GBM)
A Phase 1 study testing BEY1107 and Temozolomide in people with Glioblastoma Multiforme, run by BeyondBio Inc. at 1 site in South Korea.
Trial summary
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) Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Glioblastoma Multiforme
- What is being tested?
- BEY1107 and Temozolomide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteSouth Korea
- Study dates
- 29 Nov 2022to 31 Dec 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Subjects with progression or recurrence, with no response to the initial standard of care after being confirmed as GBM on histopathology.
- Subjects with 1 or more lesions that are measurable or evaluable according to the Response Assessment in Neuro-Oncology(RANO) criteria.
- Subjects with European Cooperative Oncology Group(ECOG) performance status 0 or 1.
- 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.
Show all 9Show fewer
- 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.
Who cannot join
- Patients with a history of chemotherapy for treatment of recurrent glioblastoma multiforme after the initial standard of care as of screening.
- Subjects who have not recovered from the toxicity of the prior anticancer therapy.
- Subjects who have past history of major gastrointestinal surgery making oral drug administration impossible or possibly affecting absorption of IP.
- Subjects who had a major surgery requiring general anesthesia within 4 weeks of screening.
- 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.
- Subjects with a genetic problem(eg. Galactose intolerance).
Show all 17Show fewer
- Subjects with hypersensitivity to the ingredient(s) or excipient(s) of the investigational product (BEY1107) or temozolomide.
- Subjects with hypersensitivity to dacarbazine (DTIC).
- Subjects who have the cardiovascular disease as of screening.
- Active hepatitis B, C or HIV positive.
- Patients with acute or severe infection.
- Subjects who take a Rifampin, Phenytoin and azole class antifungal drugs in combination.
- Subjects 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.
- Subjects with life expectancy of less than 12 weeks by the investigator.
- Subjects determined by the investigator to be ineligible for participation in this trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital
Seoul
Beyondbio Inc., +82-42-716-0020, clinicaltrials@beyondbio.co.kr
About this study
Official title: 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 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)
Read the detailed description
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.
- Conditions
- Glioblastoma Multiforme
- Being tested
- BEY1107, Temozolomide
- Keywords
- GBM
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BEY1107Drug
Administer twice daily, PO, 4-week continuous dose.
TemozolomideCombination product
Administer once daily, PO, 5-day continuous dose, followed by 23-day rest period.
| Study group | Role | What they receive |
|---|---|---|
| BEY1107 + Temozolomide | Experimental | Administer BEY1107 in combination with Temozolomide, 4-weeks as 1 cycle. Receives: Drug: BEY1107; Combination Product: Temozolomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose(MTD)
MTD will be assessed based on dose-limiting toxicity(DLT) assessment
Measured: From baseline up to disease progression, approximately 4 weeks
Recommended Phase II Dose (RP2D) assessed by investigator following administration of BEY1107 in combination with Temozolomide in Phase I.
RP2D will be assessed based on MTD.
Measured: From baseline up to disease progression, approximately 48 weeks
Secondary outcomes (5)
Disease control rate(DCR)
DCR is defined as the proportion of participants who achieved a confirmed best overall response (BOR) of complete response (CR), partial response (PR), or stable disease (SD)
Measured: From baseline up to disease progression, approximately 48 weeks
Progression-free survival(PFS) rate at 6 months
PFS is defined as the time from the start of study treatment to the date of the first documentation of objective progressive disease(PD) or death due to any cause, whichever is earlier
Measured: From baseline up to 6 months
Pharmacokinetic(PK) of maximum serum Concentration (Cmax)
Plasma concentrations at each time point and PK parameters Cmax of BEY1107 will be assessed in the PK sampling cohort
Measured: From baseline up to 4 weeks post-dose
Pharmacokinetic of Time to Reach Maximum Serum Concentration (Tmax)
Plasma concentrations at each time point and PK parameters Tmax of BEY1107 will be assessed in the PK sampling cohort
Measured: From baseline up to 4 weeks post-dose
Pharmacokinetic of Area Under the Serum Concentration-Time Curve Up to Last Quantifiable Time (AUClast)
Plasma concentrations at each time point and PK parameters AUC last of BEY1107 will be assessed in the PK sampling cohort
Measured: From baseline up to 4 weeks post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2023
- Study start29 Nov 2022
- Primary completion30 Nov 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glioblastoma MultiformeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BeyondBio Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05769660
- Sponsor's protocol ID
- BEY-2021-02
- Status last verified
- Mar 2025
- First submitted
- 5 Feb 2023
- Last updated
- 10 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT05769660
- Acronym / sponsor ID
- BEY-2021-02
- Conditions
- Glioblastoma Multiforme
- Keywords
- GBM
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- BeyondBio Inc.Industry (pharma, biotech, devices)
- Study start
- 29 Nov 2022 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 15 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BEY1107 + Temozolomide | Experimental | Drug: BEY1107, Combination Product: TemozolomideAdminister BEY1107 in combination with Temozolomide, 4-weeks as 1 cycle. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
- Subjects with progression or recurrence, with no response to the initial standard of care after being confirmed as GBM on histopathology.
- Subjects with 1 or more lesions that are measurable or evaluable according to the Response Assessment in Neuro-Oncology(RANO) criteria.
- Subjects with European Cooperative Oncology Group(ECOG) performance status 0 or 1.
Key exclusion criteria (17 listed)
- Patients with a history of chemotherapy for treatment of recurrent glioblastoma multiforme after the initial standard of care as of screening.
- Subjects who have not recovered from the toxicity of the prior anticancer therapy.
- Subjects who have past history of major gastrointestinal surgery making oral drug administration impossible or possibly affecting absorption of IP.
- Subjects who had a major surgery requiring general anesthesia within 4 weeks of screening.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BEY1107Administer twice daily, PO, 4-week continuous dose. | Drug | BEY1107 + Temozolomide |
| TemozolomideAdminister once daily, PO, 5-day continuous dose, followed by 23-day rest period. | Combination product | BEY1107 + Temozolomide |
Primary outcome
Maximum Tolerated Dose(MTD)
Time frame: From baseline up to disease progression, approximately 4 weeks
MTD will be assessed based on dose-limiting toxicity(DLT) assessment
Recommended Phase II Dose (RP2D) assessed by investigator following administration of BEY1107 in combination with Temozolomide in Phase I.
Time frame: From baseline up to disease progression, approximately 48 weeks
RP2D will be assessed based on MTD.
5 secondary outcomes
Disease control rate(DCR)
Time frame: From baseline up to disease progression, approximately 48 weeks
Progression-free survival(PFS) rate at 6 months
Time frame: From baseline up to 6 months
Pharmacokinetic(PK) of maximum serum Concentration (Cmax)
Time frame: From baseline up to 4 weeks post-dose
Pharmacokinetic of Time to Reach Maximum Serum Concentration (Tmax)
Time frame: From baseline up to 4 weeks post-dose
Pharmacokinetic of Area Under the Serum Concentration-Time Curve Up to Last Quantifiable Time (AUClast)
Time frame: From baseline up to 4 weeks post-dose
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2025.
- Individual participant dataSharing planned: No
Related trials for Glioblastoma Multiforme
RecruitingObservational study
Collection of Blood and Urine Samples in Patients Receiving Radiation Therapy for Glioblastoma Multiforme
Glioblastoma Multiforme
RecruitingPhase 2
Tamoxifen Versus Etoposide After First Recurrence in GBM Patients
Glioblastoma Multiforme
RecruitingPhase 1
A Phase 1 Safety and Dose Finding Study of GLIX1 in Adults With Recurrent or Progressive High-grade Glioma
Glioblastoma Multiforme of Brain, Glioma
Active, not recruitingPhase 2
Chemoradiotherapy Versus Chemotherapy for Elderly and Frail GBM Patients
Glioblastoma Multiforme
RecruitingPhase 2
Study of Silevertinib With Temozolomide for the Treatment of Newly Diagnosed GBM With Unmethylated MGMT and EGFRvIII
Glioblastoma (GBM), Newly Diagnosed Glioblastoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BEY1107 and Temozolomide in people with Glioblastoma Multiforme, run by BeyondBio Inc. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Tolerated Dose(MTD) (time frame: From baseline up to disease progression, approximately 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2025; AzTrials last refreshed its copy on 7 Nov 2026.