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

Glioblastoma Multiforme Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05769660
• Other study ID #: BEY-2021-02
• Status: Recruiting
• Phase: Phase 1
• Start date: November 29, 2022
• Est. completion date: October 31, 2024

Study information

• Verified date: March 2023
• Source: BeyondBio Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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)

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: October 31, 2024
• Est. primary completion date: November 29, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Glioblastoma
• Glioblastoma Multiforme

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
BeyondBio Inc.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Tolerated Dose(MTD)	MTD will be assessed based on dose-limiting toxicity(DLT) assessment	From baseline up to disease progression, approximately 4 weeks
Primary	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.	From baseline up to disease progression, approximately 48 weeks
Secondary	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)	From baseline up to disease progression, approximately 48 weeks
Secondary	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	From baseline up to 6 months
Secondary	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	From baseline up to 4 weeks post-dose
Secondary	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	From baseline up to 4 weeks post-dose
Secondary	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	From baseline up to 4 weeks post-dose