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

JenKem Technology

Status and phase: Enrolling; Phase 2

Conditions: Glioblastoma Multiforme (GBM)

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT06595186

JK-1201I-202

Details and patient eligibility

About

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.

Full description

This is a multicenter, single arm, open-label, dose-escalation phase 2 study of JK-1201I combined with adjuvant temozolomide in patients with newly diagnosed glioblastoma multiforme (GBM) after surgery and concomitant radio-chemotherapy Patients will receive JK-1201I combined with temozolomide until disease progression.

The primary objective of this study is to assess the safety of JK-1201I combined with adjuvant temozolomide in patients with newly diagnosed glioblastoma multiforme after surgery and concomitant radio-chemotherapy.

The secondary objectives of the study are to further evaluate the efficacy and pharmacokinetic profiles of JK-1201I.

Enrollment: 25 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion

Participants must meet all the following criteria to be eligible for randomization into the study:

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

Exclusion

Participants who meet any of the following criteria will be disqualified from entering the study:

1. Patients who received anti-tumor therapy except for concurrent chemo-radiotherapy (CCRT).

2. Patient diagnosed with brain stem and spinal cord tumor as the primary tumor.

3. Hypersensitivity to any ingredient of JK-1201I.

4. Severe, uncontrolled or active cardiovascular diseases within the past 6 months.

5. Inability to take medication by oral or presence of clinically significant gastrointestinal abnormalities that may affect absorption of investigational product.

6. Uncontrolled seizures.

7. Patient receiving prohibited medications and that cannot be discontinued at least 2 weeks prior to the start of treatment.

8. Severe or uncontrolled high blood pressure.

9. Unresolved toxicity from prior anti-tumor therapy.

10. Women who are pregnant or Breast-feeding. 11 Positive human immunodeficiency virus antibody, active hepatitis B virus infection, or active hepatitis C virus infection.

11. Have participated in another clinical trial within 4 weeks prior to informed consent form.

12. History of mental disorders. 14. Other conditions that the investigator considers unsuitable to participate in this clinical trial.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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25 participants in 2 patient groups

Dose Escalation Cohort

Experimental group

Description:

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.

Treatment:

Drug: JK-1201I

Drug: Temozolomide (TMZ)

Dose Expansion Cohort

Experimental group

Description:

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.

Treatment:

Drug: JK-1201I

Drug: Temozolomide (TMZ)