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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Signed informed consent form;

• Age ≥ 18 years;

• Expected survival ≥ 12 weeks;

• 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;

• 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);

• 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);

• 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;

• 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;

• Karnofsky performance status (KPS) ≥ 70 within 1 4days prior to receiving study treatment ;

⁃ Willing and able to comply with the protocol.

Locations
Other Locations
China
Beijing Tiantan Hospital Capital Medical University
RECRUITING
Beijing
Contact Information
Primary
Shuang Liu
shuang.liu@hanxbio.com
+8618601689862
Time Frame
Start Date: 2025-01-08
Estimated Completion Date: 2028-12-31
Participants
Target number of participants: 72
Treatments
Experimental: Patients received HX301/+Temozolomide treatment at assigned dose level on a 4 weeks basis
Related Therapeutic Areas
Sponsors
Leads: Hangzhou Hanx Biopharmaceuticals, Ltd.

This content was sourced from clinicaltrials.gov

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