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

Study Overview
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Brief Summary
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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.

Official Title
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A Phase III Randomized, Double-blind, Placebo-controlled, Multi-center Trial to Evaluate Safety and Efficacy pf ASC40 Tablets Combined With Bevacizumab in Subjects With Recurrent Glioblastoma

Conditions
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Recurrent Glioblastoma

Intervention / Treatment
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* Drug: ASC40 tablets
* Drug: Placebo tablets
* Drug: Bevacizumab


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ASC40<br>ASC40 tablets 100mg/m^2 and bevacizumab 10mg/kg. | Drug: ASC40 tablets<br>* ASC40 tablets administered orally once daily<br>* Other names: TVB-2640;Drug: Bevacizumab<br>* Bevacizumab once every 2 weeks, intravenous drip.<br>|
| Placebo Comparator: Placebo<br>Placebo and bevacizumab 10mg/kg. | Drug: Placebo tablets<br>* Placebo administered orally once daily.<br>Drug: Bevacizumab<br>* Bevacizumab once every 2 weeks, intravenous drip.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival | 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]) | 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 | 
| Total survival | the time from random grouping to death, compared with the control group. | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective remission rate | 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]). | Week 4 to Month 6 (every 8 weeks) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ASC40, Recurrent Glioblastoma