Study to Evaluate the Safety and Efficacy of ASC40 Tablets in Combination With Bevacizumab in Subjects With rGBM

Ascletis

Status and phase: Active, not recruiting; Phase 3

Conditions: Recurrent Glioblastoma

Treatments: Drug: Bevacizumab; Drug: ASC40 tablets; Drug: Placebo tablets

Study type: Interventional

Funder types: Industry

Identifiers

NCT05118776

ASC40-301

Details and patient eligibility

About

This is a randomized, double-blind, controlled and multi-center Phase III clinical trial to evaluate the safety and efficacy of ASC40 tablets combined with bevacizumab in the treatment of adult patients with recurrent glioblastoma. After standard radiotherapy and chemotherapy (temozolomide), the subject first experienced clinical recurrence or progression.

Enrollment: 136 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 1. Age ≥18 years old, both male and female;
• 2. Histologically confirmed glioblastoma;
• 3. Patients with glioblastoma who have failed standard treatment (surgery, Stupp regimen), were diagnosed by MRI and evaluated by RANO standard to support the first recurrence. Stupp regimen needs to complete at least 6 medication cycles.

Exclusion criteria

• 1. Use low molecular weight heparin and warfarin within 35 days before randomization;
• 2. Arterial or venous thrombosis (such as cerebral infarction, myocardial infarction, venous thrombosis of lower limbs, arterial embolism of lower limbs, pulmonary embolism, etc.) occurred within 6 months before randomization

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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136 participants in 2 patient groups, including a placebo group

ASC40

Experimental group

Description:

ASC40 tablets 100mg/m\^2 and bevacizumab 10mg/kg.

Treatment:

Drug: ASC40 tablets

Drug: Bevacizumab

Placebo

Placebo Comparator group

Description:

Placebo and bevacizumab 10mg/kg.

Treatment:

Drug: Placebo tablets

Drug: Bevacizumab