Actively Recruiting
A Phase 2 Study of HX301 in Patients with High-grade Giloma
Led by Hangzhou Hanx Biopharmaceuticals, Ltd. · Updated on 2025-01-15
72
Participants Needed
1
Research Sites
207 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The study will include a dose-escalation and dose-expansion component to establish the recommended Phase 2 dose (RP2D) for HX301 in combination with Temozolomide and to evaluate the preliminary antitumor activity of HX301.HX301 is an investigational drug that has not yet been approved by the Food and Drug Administration (FDA) or any other regulatory authorities for commercial purposes.
CONDITIONS
Official Title
A Phase 2 Study of HX301 in Patients with High-grade Giloma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent form
- Age 18 years or older
- Expected survival of at least 12 weeks
- Part I: Histologically confirmed high-grade glioma (WHO grade III or IV)
- Part I: At least one prior temozolomide treatment
- Part I: Recurrent or progressive disease with evaluable lesions per RANO criteria
- Part II: Histological or cytological diagnosis of glioblastoma per WHO 2021
- Part II: Underwent partial or complete surgical resection with documented postoperative brain MRI
- Part II: Completed initial radiotherapy combined with temozolomide according to Stupp regimen
- Part I: If radiotherapy was given, completed at least 3 months prior or has tumor progression within 3 months
- Part II: No evidence of disease progression after chemoradiotherapy except pseudoprogression
- Dexamethasone dose of 5 mg/day or less at study entry with reduction to minimum needed
- Karnofsky performance status of 70 or higher within 14 days before treatment
- Willing and able to comply with the study protocol
You will not qualify if you...
- Part II: Patients with recurrent glioblastoma
- Distant metastasis involving brainstem, meninges, or spinal cord extension
- Positive for HIV antibody, syphilis antibody, hepatitis C antibody and RNA, or hepatitis B surface antigen and DNA with specified viral load
- Hypersensitivity to temozolomide or HX301 components
- Risk factors for torsades de pointes including prolonged QT/QTc interval, history, or medications
- Grade 2 or higher diarrhea at baseline
- Participation in another investigational drug study within 30 days before first dose
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Beijing Tiantan Hospital Capital Medical University
Beijing, Beijing Municipality, China, 100083
Actively Recruiting
Research Team
S
Shuang Liu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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