Testing HX301 with Temozolomide for high-grade glioma

A Phase IIa Clinical Study of HX301 Alone or in Combination with Temozolomide in Patients with High-Grade Glioma (Grade III and IV)

This study is testing a new drug called HX301 combined with Temozolomide to see if it can help people with high-grade glioma feel better and fight their cancer more effectively.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 72 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Hangzhou Hanx Biopharmaceuticals, Ltd. (Industry-sponsored)
• Drugs / interventions: radiation
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT06703255 on ClinicalTrials.gov

What this trial studies

This clinical trial is designed to evaluate the safety and effectiveness of HX301 in combination with Temozolomide for patients with high-grade glioma. It includes a dose-escalation phase to determine the optimal dose of HX301 and a dose-expansion phase to assess its preliminary antitumor activity. Participants will be closely monitored for treatment response and side effects throughout the study. The trial aims to provide insights into a new treatment option for this challenging condition.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with histologically confirmed high-grade glioma who have previously received Temozolomide treatment.

Not a fit: Patients with low-grade glioma or those who have not received prior treatment for their condition may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could offer a new therapeutic option for patients with high-grade glioma, potentially improving survival and quality of life.

How similar studies have performed: While this approach is novel, similar studies targeting high-grade glioma with investigational drugs have shown promise, suggesting potential for success.

Eligibility criteria

Inclusion Criteria:

1. Signed informed consent form;
2. Age ≥ 18 years;
3. Expected survival ≥ 12 weeks;
4. Part I:1) Histologically confirmed high-grade glioma (WHO classification grade III or IV); 2) At least one prior temozolomide treatment; 3) Patients with recurrent or progressive clinically assessed disease according to RANO criteria with evaluable lesions; Part II: Patients with histological or cytological diagnosis of glioblastoma according to World Health Organization (WHO) classification (2021) who received surgical treatment for the first time and standard concurrent chemoradiotherapy and who have not received any other prior treatment;
5. Part II: Subjects must undergo partial or complete surgical resection, and available results of postoperative brain contrast-enhanced MRI were documented as follows: 1) complete resection without gadolinium enhancement ; or 2) complete resection (80% or more);
6. Part II: Subjects must complete initial radiotherapy combined with TMZ (concurrent chemoradiotherapy) for glioblastoma according to the Stupp regimen (Stupp 2005) (total radiation dose 5 4-60 G y);
7. Part I: If radiotherapy has been performed, the completion of radiotherapy shall last for 3 months, or there shall be tumor progression or histopathological confirmation of progression in the original radiation field within 3 months; Part II: there shall be no evidence of disease progression after chemoradiotherapy, except for pseudo progression;
8. Dexamethasone was administered at ≤ 5 mg/day at study entry.Corticosteroids should be reduced as far as possible to the smallest dose necessary to control neurological symptoms before receiving study treatment;
9. Karnofsky performance status (KPS) ≥ 70 within 1 4days prior to receiving study treatment ;
10. Willing and able to comply with the protocol.

Exclusion Criteria:

1. Part II: Patients with recurrent glioblastoma;
2. Distant metastasis involving brainstem and meninges or extension of lesions to spinal cord;
3. Human immunodeficiency virus (HIV) antibody positive, syphilis antibody (Anti-TP) positive, hepatitis C virus (HCV) antibody positive and HCV RNA positive, hepatitis B virus surface antigen (HBsAg) positive and HBV DNA positive (HBsAg positive requires further detection of HBV DNA, HBV DNA ≥ 200 IU/ml, or ≥ 10 3 copies/ml);
4. Hypersensitivity to temozolomide and/or components of HX301;
5. At risk for torsades de pointes (TdP): patients with a marked prolongation of the QT/QTc interval calculated using the Fredericia QT correction formula at baseline (eg, repeated demonstration of QTc interval \> 470 ms), or a history of other TdP risk factors (eg, heart failure, hypokalemia, family history of long QT syndrome), or patients who are currently taking medications that prolong the QT/QTc interval;
6. Grade ≥ 2 diarrhea at baseline;
7. Participation in another study involving an investigational drug within 30 days prior to the first dose of study drug;

Where this trial is running

Beijing, Beijing Municipality

• Beijing Tiantan Hospital Capital Medical University — Beijing, Beijing Municipality, China (Recruiting)

Study contacts

• Study coordinator: Shuang Liu

Conditions Glioma