Phase 2 Clinical Trial of KH617

NCT07138001 | Not Yet Recruiting Phase 2

• 1 other identifier: KH617-30201
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief 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

Conditions

Recurrent Glioblastoma

Outcome Measures

Primary Outcomes (3)

• ORR

  54 weeks

• PFS-6

  54 weeks

• TEAE

  54 weeks

Secondary Outcomes (4)

• DOR

  54 weeks

• PFS

  54 weeks

• OS

  54 weeks

• EORTC QLQ-BN20

  54 weeks

Study Arms (3)

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.

Combination Product: KH617+TMZ

KH617

EXPERIMENTAL

KH617： 33mg/kg intravenous infusion, every 4 weeks as one cycle.

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.

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

Interventions

KH617+TMZ COMBINATION_PRODUCT

use KH617 and TMZ(5/28) as Combination Product.

KH617+TMZ

KH617 DRUG

Single Clinical trial investigational drug

KH617

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

Comparator product, Two treatment options for physicians and subjects to choose from: 1. use TMZ(7/7) 2. Use Platinum (cisplatin or carboplatin)+VP-16

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

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Sichuan Honghe Biotechnology Co., Ltd.: lead

MeSH Terms

Conditions

Glioblastoma

Interventions

Platinum; Cisplatin

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)

Metals, Heavy; Elements; Inorganic Chemicals; Transition Elements; Metals; Chlorine Compounds; Nitrogen Compounds; Platinum Compounds

Study Officials

• Wenbin Li

  Beijing Titan Hospital,Capital Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Manxi Zhao

CONTACT

86 15882459305; zhaomanqian@cnkh.com

Jiaojiao Liang

CONTACT

86 18180980577; 027056@cnkh.com

Study Design

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

Study Record Dates

• First Submitted: August 15, 2025
• First Posted: August 22, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): December 1, 2030
• Last Updated: August 22, 2025

Record last verified: 2025-08