Clinical trial NCT05769660: A Study to Evaluate Safety and Efficacy of BEY1107 in Combination with Temozolomide in Patients with Recurrent or Progressive Glioblastoma Multiforme (GBM)
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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Glioblastoma Multiforme
Keywords: GBM
Lead sponsor: BeyondBio Inc.
Sponsor class: INDUSTRY
First posted: 2023-03-15
Enrollment: 12
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief 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.

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.

Primary outcomes:
measure: Maximum Tolerated Dose(MTD)
timeFrame: From baseline up to disease progression, approximately 4 weeks
measure: Recommended Phase II Dose (RP2D) assessed by investigator following administration of BEY1107 in combination with Temozolomide in Phase I.
timeFrame: From baseline up to disease progression, approximately 48 weeks
Secondary outcomes:
measure: Disease control rate(DCR)
timeFrame: From baseline up to disease progression, approximately 48 weeks
measure: Progression-free survival(PFS) rate at 6 months
timeFrame: From baseline up to 6 months
measure: Pharmacokinetic(PK) of maximum serum Concentration (Cmax)
timeFrame: From baseline up to 4 weeks post-dose
measure: Pharmacokinetic of Time to Reach Maximum Serum Concentration (Tmax)
timeFrame: From baseline up to 4 weeks post-dose
measure: Pharmacokinetic of Area Under the Serum Concentration-Time Curve Up to Last Quantifiable Time (AUClast)
timeFrame: From baseline up to 4 weeks post-dose
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References: