Actively Recruiting
A Phase IIa Clinical Study of HX301 Alone or with Temozolomide in Patients with High-Grade Glioma (Grade III and IV)
Led by Hangzhou Hanx Biopharmaceuticals, Ltd. · Updated on 2025-01-15
72
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting a Phase IIa clinical study to evaluate the investigational drug HX301 alone or combined with Temozolomide in patients with high-grade glioma (Grade III and IV). The study aims to find the recommended dose for Phase 2 and assess preliminary antitumor activity. HX301 is not yet approved by regulatory authorities and is being studied for its safety and effectiveness in this patient group. The study includes two parts: Part I explores HX301 monotherapy with dose escalation, starting at 160 mg and possibly reducing to 120 mg if needed, given in cycles of 28 days for up to 24 cycles. Part II evaluates HX301 combined with Temozolomide after chemoradiotherapy, with Temozolomide given in cycles of 150 mg/m2 daily for 5 days initially, possibly increasing to 200 mg/m2 for up to 12 cycles. After Temozolomide, participants continue HX301 monotherapy for up to 12 additional cycles. Participants will undergo safety monitoring, including tracking adverse events, and assessments of tumor response using RANO criteria during the 24 cycles. The study measures progression-free survival, objective response rate, and overall survival. Safety evaluations cover all adverse events during and up to 28 days after treatment. The total participation may extend through multiple treatment cycles, with careful follow-up and protocol compliance required.
CONDITIONS
Brief 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
- For Part I: Histologically confirmed high-grade glioma (WHO grade III or IV)
- For Part I: At least one prior Temozolomide treatment
- For Part I: Recurrent or progressive disease with evaluable lesions per RANO criteria
- For Part II: Histological or cytological diagnosis of glioblastoma
- For Part II: Underwent surgical treatment for first time and standard chemoradiotherapy
- For Part II: Partial or complete surgical resection with documented postoperative MRI results
- For Part II: Completed initial radiotherapy combined with Temozolomide per Stupp regimen
- For Part I: If radiotherapy done, completed at least 3 months prior or evidence of progression
- For Part II: No disease progression after chemoradiotherapy except pseudoprogression
- Use of Dexamethasone at 5 mg/day or less at study entry with dose reduced as possible
- Karnofsky performance status of 70 or higher within 14 days prior to treatment
- Willing and able to comply with the study protocol
You will not qualify if you...
- For Part II: Patients with recurrent glioblastoma
- Distant metastasis involving brainstem, meninges, or spinal cord extension
- Positive for HIV antibodies, syphilis antibodies, hepatitis B or C with active infection
- Hypersensitivity to Temozolomide or components of HX301
- Risk factors for torsades de pointes including prolonged QT interval or related conditions
- Grade 2 or higher diarrhea at baseline
- Participation in another investigational drug study within 30 days prior to first dose of study drug
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 24 cycles of 28 days each
Participants receive HX301 monotherapy or HX301 in combination with temozolomide in cycles of 28 days each until disease progression, intolerable toxicity, or other reasons for stopping treatment.
Treatment visits every 4 weeks
Duration - Up to 24 cycles of 28 days each
Following chemoradiotherapy, participants receive combination therapy with HX301 and temozolomide for up to 12 cycles of 28 days each, followed by HX301 monotherapy for a maximum of 12 cycles of 28 days each.
Treatment visits every 4 weeks
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
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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