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

NCT ID: NCT05118776

Last Updated: 2024-10-31

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 136 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-21
• Study Completion Date: 2025-06-30

Brief Summary

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.

Conditions

Recurrent Glioblastoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

ASC40

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

Group Type: EXPERIMENTAL

ASC40 tablets

Intervention Type: DRUG

ASC40 tablets administered orally once daily

Bevacizumab

Intervention Type: DRUG

Bevacizumab once every 2 weeks, intravenous drip.

Placebo

Placebo and bevacizumab 10mg/kg.

Group Type: PLACEBO_COMPARATOR

Placebo tablets

Intervention Type: DRUG

Placebo administered orally once daily.

Bevacizumab

Intervention Type: DRUG

Bevacizumab once every 2 weeks, intravenous drip.

Interventions

ASC40 tablets

ASC40 tablets administered orally once daily

Intervention Type: DRUG

Placebo tablets

Placebo administered orally once daily.

Intervention Type: DRUG

Bevacizumab

Bevacizumab once every 2 weeks, intravenous drip.

Intervention Type: DRUG

Other Intervention Names

TVB-2640

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ascletis Pharmaceuticals Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Beijing Tiantan Hospital，Capital Medical University

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

ASC40-301

Identifier Type: -

Identifier Source: org_study_id