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Trial Title:
A Study to Evaluate Safety and Efficacy of BEY1107 in Combination With Temozolomide in Patients With Recurrent or Progressive Glioblastoma Multiforme (GBM)
NCT ID:
NCT05769660
Condition:
Glioblastoma Multiforme
Conditions: Official terms:
Glioblastoma
Temozolomide
Conditions: Keywords:
GBM
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Masking description:
open label
Intervention:
Intervention type:
Drug
Intervention name:
BEY1107
Description:
Administer twice daily, PO, 4-week continuous dose.
Arm group label:
BEY1107 + Temozolomide
Intervention type:
Combination Product
Intervention name:
Temozolomide
Description:
Administer once daily, PO, 5-day continuous dose, followed by 23-day rest period.
Arm group label:
BEY1107 + Temozolomide
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)
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.
Criteria for eligibility:
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.
Gender:
All
Minimum age:
19 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Seoul National University Hospital
Address:
City:
Seoul
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Beyondbio Inc.
Phone:
+82-42-716-0020
Email:
clinicaltrials@beyondbio.co.kr
Start date:
November 29, 2022
Completion date:
October 31, 2024
Lead sponsor:
Agency:
BeyondBio Inc.
Agency class:
Industry
Source:
BeyondBio Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05769660
