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

NCT05769660 | Recruiting Phase 1

• 1 other identifier: BEY-2021-02
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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)

Conditions

Glioblastoma Multiforme

Keywords

GBM

Outcome Measures

Primary Outcomes (2)

• Maximum Tolerated Dose(MTD)

  MTD will be assessed based on dose-limiting toxicity(DLT) assessment

  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.

  From baseline up to disease progression, approximately 48 weeks

Secondary Outcomes (5)

• Disease control rate(DCR)

  From baseline up to disease progression, approximately 48 weeks

• Progression-free survival(PFS) rate at 6 months

  From baseline up to 6 months

• Pharmacokinetic(PK) of maximum serum Concentration (Cmax)

  From baseline up to 4 weeks post-dose

• Pharmacokinetic of Time to Reach Maximum Serum Concentration (Tmax)

  From baseline up to 4 weeks post-dose

• Pharmacokinetic of Area Under the Serum Concentration-Time Curve Up to Last Quantifiable Time (AUClast)

  From baseline up to 4 weeks post-dose

Study Arms (1)

BEY1107 + Temozolomide

EXPERIMENTAL

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

Drug: BEY1107; Combination Product: Temozolomide

Interventions

BEY1107 DRUG

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

BEY1107 + Temozolomide

Temozolomide COMBINATION_PRODUCT

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

BEY1107 + Temozolomide

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.
• 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.
• \. 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.

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• BeyondBio Inc.: lead

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Glioblastoma

Interventions

Temozolomide

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Dacarbazine; Triazenes; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Masking Details: open label
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2023
• First Posted: March 15, 2023
• Study Start: November 29, 2022
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 10, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)