Glioblastoma Multiforme (GBM)Phase 2NCT06595186
JK-1201I Combined with Adjuvant Temozolomide in Patients with Newly Diagnosed Glioblastoma Multiforme (GBM)
A Phase 2 study testing JK-1201I and Temozolomide (TMZ) in people with Glioblastoma Multiforme (GBM), run by JenKem Technology Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Glioblastoma Multiforme (GBM)
- What is being tested?
- JK-1201I and Temozolomide (TMZ)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteChina
- Study dates
- 31 Oct 2022to 16 Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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).
Who cannot join
- 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.
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- 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.
- 12. Have participated in another clinical trial within 4 weeks prior to informed consent form.
- 13. History of mental disorders. 14. Other conditions that the investigator considers unsuitable to participate in this clinical trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing Tiantan Hospital
Beijing
Wenbin LI, 8610-82156767, yahuisu@jenkem.com
About this study
Official title: 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
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.
Read the detailed 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.
- Conditions
- Glioblastoma Multiforme (GBM)
- Being tested
- JK-1201I, Temozolomide (TMZ)
- Keywords
- glioblastoma multiforme
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JK-1201IDrug
JK-1201I will be administered.
Temozolomide (TMZ)Drug
Temozolomide will be administered.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: JK-1201I; Drug: Temozolomide (TMZ) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Progression-free Survival (PFS) is defined as the time interval from the randomization to disease progression or death due to any cause.
Measured: 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)
Overall survival (OS) is defined as the time interval from randomization to death due to any cause.
Measured: 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
Area under the plasma concentration-time curve up to the last quantifiable time point (AUClast) and area under the plasma concentration-time curve dosing interval (AUCtau) will be assessed using Non-linear mixed effect modeling.
Measured: Up to 6 months.
Pharmacokinetic Parameter Maximum Concentration for JK-1201I, Irinotecan, SN38 and SN38G
Maximum concentration (Cmax) will be assessed using Non-linear mixed effect modeling.
Measured: Up to 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start31 Oct 2022
- Primary completion16 Aug 2026 (estimated)
- Study completion16 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glioblastoma Multiforme (GBM)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- JenKem Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06595186
- Sponsor's protocol ID
- JK-1201I-202
- Status last verified
- Sep 2024
- First submitted
- 4 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06595186
- Acronym / sponsor ID
- JK-1201I-202
- Conditions
- Glioblastoma Multiforme (GBM)
- Keywords
- glioblastoma multiforme
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- JenKem Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 31 Oct 2022 (actual)
- Primary completion
- 16 Aug 2026 (estimated)
- Study completion
- 16 Dec 2026 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation Cohort | Experimental | Drug: JK-1201I, Drug: Temozolomide (TMZ)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. |
| Dose Expansion Cohort | Experimental | Drug: JK-1201I, Drug: Temozolomide (TMZ)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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JK-1201IJK-1201I will be administered. | Drug | Dose Escalation Cohort, Dose Expansion Cohort |
| Temozolomide (TMZ)Temozolomide will be administered. | Drug | Dose Escalation Cohort, Dose Expansion Cohort |
Primary outcome
Incidence and Grade of Participants with Adverse Events or Serious Adverse Events
Time frame: From the date of first dose to the end of safety follow-up; Up to 12 months.
Adverse Events (AEs) or Serious Adverse Events (SAEs) are assessed based on NCI CTCAE v5.0.
4 secondary outcomes
Progression-free Survival (PFS) Assessed by Investigators
Time frame: 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)
Time frame: 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
Time frame: Up to 6 months.
Pharmacokinetic Parameter Maximum Concentration for JK-1201I, Irinotecan, SN38 and SN38G
Time frame: Up to 6 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing JK-1201I and Temozolomide (TMZ) in people with Glioblastoma Multiforme (GBM), run by JenKem Technology Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yahui SU (8610-82156767, yahuisu@jenkem.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and Grade of Participants with Adverse Events or Serious Adverse Events (time frame: From the date of first dose to the end of safety follow-up; Up to 12 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024; AzTrials last refreshed its copy on 8 Nov 2026.