JK-1201I Combined with Adjuvant Temozolomide in Patients with Newly Diagnosed Glioblastoma Multiforme (GBM)

NCT06595186 | Recruiting Phase 2

• 1 other identifier: JK-1201I-202
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

This study was designed to evaluate the safety, tolerability, efficacy and pharmacokinetics of JK-1201I combined with adjuvant temozolomide in patients with newly diagnosed glioblastoma multiforme after surgery and concomitant radio-chemotherapy.

Conditions

Glioblastoma Multiforme (GBM)

Keywords

glioblastoma multiforme

Outcome Measures

Primary Outcomes (1)

• Incidence and Grade of Participants with Adverse Events or Serious Adverse Events

  Adverse Events (AEs) or Serious Adverse Events (SAEs) are assessed based on NCI CTCAE v5.0.

  From the date of first dose to the end of safety follow-up; Up to 12 months.

Secondary Outcomes (4)

• Progression-free Survival (PFS) Assessed by Investigators

  From the date of randomization to documented progressive disease, death, lost to follow-up, or withdrawal by the participant; Up to 12 months.

• Overall survival (OS)

  From the date of randomization to the date of death due to any cause; Up to 12 months.

• Pharmacokinetic Parameter Area Under the Plasma Concentration-Time Curve for JK-1201I, Irinotecan, SN38 and SN38G

  Up to 6 months.

• Pharmacokinetic Parameter Maximum Concentration for JK-1201I, Irinotecan, SN38 and SN38G

  Up to 6 months.

Study Arms (2)

Dose Escalation Cohort

EXPERIMENTAL

Participants will receive JK-1201I as an intravenous (IV) infusion at each 14-day cycle (Q2W) until a treatment discontinuation criterion is met as specified in the protocol. Escalating doses of JK-1201I will be evaluated by the traditional 3+3 design. Temozolomide will be administered per drug label.

Drug: JK-1201I; Drug: Temozolomide (TMZ)

Dose Expansion Cohort

EXPERIMENTAL

Participants will receive JK-1201I as an intravenous (IV) infusion as the recommended Phase 2 dose at each 14-day cycle (Q2W) until a treatment discontinuation criterion is met as specified in the protocol. Temozolomide will be administered per drug label.

Drug: JK-1201I; Drug: Temozolomide (TMZ)

Interventions

JK-1201I DRUG

JK-1201I will be administered.

Dose Escalation Cohort; Dose Expansion Cohort

Temozolomide (TMZ) DRUG

Temozolomide will be administered.

Dose Escalation Cohort; Dose Expansion Cohort

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must meet all the following criteria to be eligible for randomization into the study:
• Male or female aged ≥18 years and ≤75 years.
• Patients newly diagnosed with glioblastoma either by imaging or pathology testing, Gross total resection equal to or greater than 80%.
• Patients must finish concurrent chemo-radiotherapy (CCRT) no sooner than 4 weeks and no later than 6 weeks.
• Stable dose or reduced dose of corticosteroid for more than 2 weeks.
• Karnofsky score ≥ 70.
• Life expectancy \> 12 weeks.
• Adequate biological function.
• Men or women should be using adequate contraceptive measures during the study and for 6 months following the last dose of investigational product.
• Sign and date the informed consent form prior to the start of any study-specific qualification procedures.
• MGMT unmethylation (only for Dose Expansion Cohort).

You may not qualify if:

• Participants who meet any of the following criteria will be disqualified from entering the study:
• Patients who received anti-tumor therapy except for concurrent chemo-radiotherapy (CCRT).
• Patient diagnosed with brain stem and spinal cord tumor as the primary tumor.
• Hypersensitivity to any ingredient of JK-1201I.
• Severe, uncontrolled or active cardiovascular diseases within the past 6 months.
• Inability to take medication by oral or presence of clinically significant gastrointestinal abnormalities that may affect absorption of investigational product.
• Uncontrolled seizures.
• Patient receiving prohibited medications and that cannot be discontinued at least 2 weeks prior to the start of treatment.
• Severe or uncontrolled high blood pressure.
• Unresolved toxicity from prior anti-tumor therapy.
• Women who are pregnant or Breast-feeding. 11 Positive human immunodeficiency virus antibody, active hepatitis B virus infection, or active hepatitis C virus infection.
• \. Have participated in another clinical trial within 4 weeks prior to informed consent form.
• \. History of mental disorders. 14. Other conditions that the investigator considers unsuitable to participate in this clinical trial.

Sponsors & Collaborators

• JenKem Technology Co., Ltd.: lead

Study Sites (1)

Beijing Tiantan Hospital

Beijing, China

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

Central Study Contacts

Yahui SU

CONTACT

8610-82156767; yahuisu@jenkem.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2024
• First Posted: September 19, 2024
• Study Start: October 31, 2022
• Primary Completion (Estimated): August 16, 2026
• Study Completion (Estimated): December 16, 2026
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

CN (1)