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

Phase 3

Active, not recruiting

• Conditions: Recurrent Glioblastoma
• Interventions: Drug: ASC40 tablets; Drug: Placebo tablets; Drug: Bevacizumab

• Registration Number: NCT05118776
• Lead Sponsor: Ascletis Pharmaceuticals Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-10-26
• Study First Submitted QC: 2021-11-02
• Study First Posted: 2021-11-12
• Study Start: 2022-01-21
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-30
• Last Update Posted: 2024-10-31
• Primary Completion: 2025-06
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 136

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ASC40	ASC40 tablets	ASC40 tablets 100mg/m\^2 and bevacizumab 10mg/kg.
Placebo	Placebo tablets	Placebo and bevacizumab 10mg/kg.
ASC40	Bevacizumab	ASC40 tablets 100mg/m\^2 and bevacizumab 10mg/kg.
Placebo	Bevacizumab	Placebo and bevacizumab 10mg/kg.

Primary Outcome Measures

Name	Time	Method
Progression-free survival	From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 6 months	The time of progression or death from any cause in randomly grouped diseases (whichever comes first) was compared with the control group (evaluated by Independent Imaging Evaluation Committee \[IRC\])
Total survival	From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 10 months	the time from random grouping to death, compared with the control group.

Secondary Outcome Measures

Name	Time	Method
Objective remission rate	Week 4 to Month 6 (every 8 weeks)	It is evaluated once in the 4th week after using experimental drugs (experimental drug group or control group), and then every 8 weeks until the disease progresses or dies (evaluated by \[IRC\]).

Trial Locations

Locations (1)

Beijing Tiantan Hospital，Capital Medical University; 🇨🇳 Beijing, Beijing, China