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

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)

Study Overview

• Status: Recruiting
• Conditions: Glioblastoma Multiforme
• Intervention / Treatment: Drug: BEY1107; Combination product: Temozolomide

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 Type: Interventional
• Enrollment (Anticipated): 12
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Recruiting
    • Seoul National University Hospital
    • Contact: Beyondbio Inc.; Phone Number: +82-42-716-0020; Email: clinicaltrials@beyondbio.co.kr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BEY1107 + Temozolomide; Administer BEY1107 in combination with Temozolomide, 4-weeks as 1 cycle.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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

Collaborators and Investigators

• Sponsor: BeyondBio Inc.

Study record dates

Study Major Dates

• Study Start (Actual): November 29, 2022
• Primary Completion (Anticipated): November 29, 2023
• Study Completion (Anticipated): October 31, 2024

Study Registration Dates

• First Submitted: February 5, 2023
• First Submitted That Met QC Criteria: March 13, 2023
• First Posted (Actual): March 15, 2023

Study Record Updates

• Last Update Posted (Actual): March 15, 2023
• Last Update Submitted That Met QC Criteria: March 13, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: GBM
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Glioblastoma; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Antineoplastic Agents, Alkylating; Alkylating Agents; Temozolomide
• Other Study ID Numbers: BEY-2021-02

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No