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Phase 2 Clinical Trial of KH617 | Clinical Trials | Clareo Health

NOT_YET_RECRUITINGPHASE2

Phase 2 Clinical Trial of KH617

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

NCT07138001•Sichuan Honghe Biotechnology Co., Ltd.

View on ClinicalTrials.gov

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

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Male or female,age≥18 years old.
•2. Life expectancy of at least 3 months.
•3. Glioblastoma confirmed by histopathology.
•4. Glioblastoma that recurred for the first time after failure of standard treatment.
•5. Patient has at least one measurable lesion by iRANO.
•6. MGMT promoter is unmethylated.
•7. KPS≥ 60.
•8. Adequate organ and bone marrow reserve function.

Exclusion Criteria

•1. Pregnant or breastfeeding women, or women or men who are planning to have children.
•2. Patients who have received the following treatments before enrollment should be excluded:
•1. 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.
•2. Patients who had undergone intracranial lesion biopsy within 7 days before enrollment.
•3. Received other clinical research drugs or treatments within 4 weeks before enrollment.
•4. Received treatment with traditional Chinese medicine or Chinese patent medicine with anti-tumor effects within 1 week before enrollment.
•3. History of central nervous system hemorrhage/infarction, such as ischemic/hemorrhagic stroke, within 6 months before enrollment.
•4. Known history of unstable angina, myocardial infarction, or congestive heart failure within the past 6 months or clinically significant arrhythmia requiring antiarrhythmic therapy.
•5. Poorly controlled high blood pressure or diabetes.
•6. Uncontrolled pleural effusion, pericardial effusion, or ascites.
+11 more criteria

Key Dates

Start Date

August 1, 2025

Primary Completion Date

September 1, 2027

Completion Date

December 1, 2030

Last Updated

August 22, 2025

Enrollment

ESTIMATED participants

Conditions

Recurrent Glioblastoma

Interventions

KH617+TMZ

COMBINATION_PRODUCT

KH617

DRUG

TPC: TMZ or Platinum (cisplatin or carboplatin)+VP-16

DRUG

Contacts

Manxi Zhao

CONTACT

86 15882459305 zhaomanqian@cnkh.com

Jiaojiao Liang

CONTACT

86 18180980577 027056@cnkh.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 22, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Phase 2 Clinical Trial of KH617

Inclusion Criteria

Exclusion Criteria

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