Recurrent GlioblastomaPhase 2NCT07138001
Phase 2 Clinical Trial of KH617
A Phase 2 study testing KH617+TMZ, KH617 and TPC: TMZ or Platinum (cisplatin or carboplatin)+VP-16 in people with Recurrent Glioblastoma, run by Sichuan Honghe Biotechnology Co., Ltd..
Trial summary
To evaluate the efficacy and safety of KH617 for injection in combination with temozolomide versus investigator's choice therapy or KH617 monotherapy for recurrent glioblastoma Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Recurrent Glioblastoma
- What is being tested?
- KH617+TMZ, KH617 and TPC: TMZ or Platinum (cisplatin or carboplatin)+VP-16
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Aug 2025to Dec 2030
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female,age≥18 years old.
- Life expectancy of at least 3 months.
- Glioblastoma confirmed by histopathology.
- Glioblastoma that recurred for the first time after failure of standard treatment.
- Patient has at least one measurable lesion by iRANO.
- MGMT promoter is unmethylated.
- KPS≥ 60.
- Adequate organ and bone marrow reserve function.
Who cannot join
- Pregnant or breastfeeding women, or women or men who are planning to have children.
- Patients who have received the following treatments before enrollment should be excluded:
- Patients who have received surgery, chemotherapy, targeted and immune drug therapy, iodine internal radiation, or radiotherapy within 4 weeks or 5 half-lives (whichever is shorter) before enrollment or who plan to receive radiotherapy during the trial.
- Patients who had undergone intracranial lesion biopsy within 7 days before enrollment.
- Received other clinical research drugs or treatments within 4 weeks before enrollment.
- Received treatment with traditional Chinese medicine or Chinese patent medicine with anti-tumor effects within 1 week before enrollment.
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- History of central nervous system hemorrhage/infarction, such as ischemic/hemorrhagic stroke, within 6 months before enrollment.
- Known history of unstable angina, myocardial infarction, or congestive heart failure within the past 6 months or clinically significant arrhythmia requiring antiarrhythmic therapy.
- Poorly controlled high blood pressure or diabetes.
- Uncontrolled pleural effusion, pericardial effusion, or ascites.
- Patients at risk for active autoimmune disease or those with a history of autoimmune disease that may involve the central nervous system.
- Pulmonary disease defined as grade ≥3 according to NCI-CTCAE v5.0.
- Significant active bleeding within 6 months before the first dose.
- Newly diagnosed thromboembolic events requiring treatment within 6 months before the first dose.
- Other malignant tumors diagnosed within 5 years before the first dose.
- Known allergy to any component of KH617.
- Positive human immunodeficiency virus (HIV) antibodies, active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection, and the presence of untreated or currently treated tuberculosis in the patient.
- Patients who have received allogeneic cell or solid organ transplantation.
- Active infection requiring systemic therapy.
- Known history of psychotropic substance abuse, alcoholism, or drug abuse.
- Other circumstances that the researcher deems unsuitable for participation in this clinical trial.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Randomized, Controlled, Open-label, Multicenter Phase 2 Clinical Trial to Evaluate the Efficacy and Safety of KH617 in Combination With Temozolomide Versus Investigator's Choice Treatment or KH617 Monotherapy for Recurrent Glioblastoma
To evaluate the efficacy and safety of KH617 for injection in combination with temozolomide versus investigator's choice therapy or KH617 monotherapy for recurrent glioblastoma
- Conditions
- Recurrent Glioblastoma
- Being tested
- KH617+TMZ, KH617, TPC: TMZ or Platinum (cisplatin or carboplatin)+VP-16
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KH617+TMZCombination product
use KH617 and TMZ(5/28) as Combination Product.
KH617Drug
Single Clinical trial investigational drug
TPC: TMZ or Platinum (cisplatin or carboplatin)+VP-16Drug
Comparator product, Two treatment options for physicians and subjects to choose from:
- use TMZ(7/7)
- Use Platinum (cisplatin or carboplatin)+VP-16
| Study group | Role | What they receive |
|---|---|---|
| KH617+TMZ | Experimental | KH617： 33mg/kg intravenous infusion, every 4 weeks as one cycle.
TMZ（5/28）：150~200mg/m2/d, oral, every 4 weeks as one cycle. Receives: Combination Product: KH617+TMZ |
| KH617 | Experimental | KH617： 33mg/kg intravenous infusion, every 4 weeks as one cycle. Receives: Drug: KH617 |
| TPC: TMZ or Platinum (cisplatin or carboplatin)+VP-16 | Active comparator | TMZ（7/7）： 100-150 mg/m2/d，oral, alternating weekly,every 4 weeks as one cycle.
Platinum (cisplatin or carboplatin)+VP-16： Cisplatin for injection 80-100mg/m2, divided into 3 days, the dose depends on tolerability, every 4 weeks as one cycle; carboplatin injection 75-100mg/m2/d, continuously administered for 3 days, the dose depends on tolerability, every 4 weeks as one cycle; etoposide injection 100mg/m2/d, continuously administered for 3 days, every 4 weeks as one cycle. Receives: Drug: TPC: TMZ or Platinum (cisplatin or carboplatin)+VP-16 |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR
Measured: 54 weeks
PFS-6
Measured: 54 weeks
TEAE
Measured: 54 weeks
Secondary outcomes (4)
DOR
Measured: 54 weeks
PFS
Measured: 54 weeks
OS
Measured: 54 weeks
EORTC QLQ-BN20
Measured: 54 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2025
- Study startAug 2025 (estimated)
- Primary completionSep 2027 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent GlioblastomaStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sichuan Honghe Biotechnology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Wenbin Li, Principal investigator, Beijing Titan Hospital,Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07138001
- Sponsor's protocol ID
- KH617-30201
- Status last verified
- Aug 2025
- First submitted
- 15 Aug 2025
- Last updated
- 22 Aug 2025
- 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 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled, Open-label, Multicenter Phase 2 Clinical Trial to Evaluate the Efficacy and Safety of KH617 in Combination With Temozolomide Versus Investigator's Choice Treatment or KH617 Monotherapy for Recurrent Glioblastoma
- ClinicalTrials.gov ID
- NCT07138001
- Acronym / sponsor ID
- KH617-30201
- Conditions
- Recurrent Glioblastoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Sichuan Honghe Biotechnology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Aug 2025 (estimated)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 22 Aug 2025 (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.
To evaluate the efficacy and safety of KH617 for injection in combination with temozolomide versus investigator's choice therapy or KH617 monotherapy for recurrent glioblastoma
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| KH617+TMZ | Experimental | Combination Product: KH617+TMZKH617： 33mg/kg intravenous infusion, every 4 weeks as one cycle. TMZ（5/28）：150~200mg/m2/d, oral, every 4 weeks as one cycle. |
| KH617 | Experimental | Drug: KH617KH617： 33mg/kg intravenous infusion, every 4 weeks as one cycle. |
| TPC: TMZ or Platinum (cisplatin or carboplatin)+VP-16 | Active comparator | Drug: TPC: TMZ or Platinum (cisplatin or carboplatin)+VP-16TMZ（7/7）： 100-150 mg/m2/d，oral, alternating weekly,every 4 weeks as one cycle. Platinum (cisplatin or carboplatin)+VP-16： Cisplatin for injection 80-100mg/m2, divided into 3 days, the dose depends on tolerability, every 4 weeks as one cycle; carboplatin injection 75-100mg/m2/d, continuously administered for 3 days, the dose depends on tolerability, every 4 weeks as one cycle; etoposide injection 100mg/m2/d, continuously administered for 3 days, every 4 weeks as one cycle. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female,age≥18 years old.
- Life expectancy of at least 3 months.
- Glioblastoma confirmed by histopathology.
- Glioblastoma that recurred for the first time after failure of standard treatment.
- Patient has at least one measurable lesion by iRANO.
Key exclusion criteria (21 listed)
- Pregnant or breastfeeding women, or women or men who are planning to have children.
- Patients who have received the following treatments before enrollment should be excluded:
- History of central nervous system hemorrhage/infarction, such as ischemic/hemorrhagic stroke, within 6 months before enrollment.
- Known history of unstable angina, myocardial infarction, or congestive heart failure within the past 6 months or clinically significant arrhythmia requiring antiarrhythmic therapy.
- Poorly controlled high blood pressure or diabetes.
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 |
|---|---|---|
| KH617+TMZuse KH617 and TMZ(5/28) as Combination Product. | Combination product | KH617+TMZ |
| KH617Single Clinical trial investigational drug | Drug | KH617 |
| TPC: TMZ or Platinum (cisplatin or carboplatin)+VP-16Comparator product, Two treatment options for physicians and subjects to choose from: 1. use TMZ(7/7) 2. Use Platinum (cisplatin or carboplatin)+VP-16 | Drug | TPC: TMZ or Platinum (cisplatin or carboplatin)+VP-16 |
Primary outcome
ORR
Time frame: 54 weeks
PFS-6
Time frame: 54 weeks
TEAE
Time frame: 54 weeks
4 secondary outcomes
DOR
Time frame: 54 weeks
PFS
Time frame: 54 weeks
OS
Time frame: 54 weeks
EORTC QLQ-BN20
Time frame: 54 weeks
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 22 Aug 2025.
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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.
Wenbin Li principal investigator
Beijing Titan Hospital,Capital Medical University
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing KH617+TMZ, KH617 and TPC: TMZ or Platinum (cisplatin or carboplatin)+VP-16 in people with Recurrent Glioblastoma, run by Sichuan Honghe Biotechnology Co., Ltd..
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 8 inclusion and 21 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: opening soon, as of the sponsor's last update on 22 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
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 Manxi Zhao (86 15882459305, zhaomanqian@cnkh.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR (time frame: 54 weeks). The study lists 3 primary outcomes in all. 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 22 Aug 2025.