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

Primary Purpose

Recurrent Glioblastoma

Status

Recruiting

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

ASC40 tablets

Placebo tablets

Bevacizumab

About this trial

This is an interventional treatment trial for Recurrent Glioblastoma focused on measuring ASC40, Recurrent Glioblastoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Beijing Tiantan Hospital，Capital Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

ASC40

Placebo

Arm Description

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

Placebo and bevacizumab 10mg/kg.

Outcomes

Primary Outcome Measures

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])

Total survival

the time from random grouping to death, compared with the control group.

Secondary Outcome Measures

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]).

Full Information

NCT ID

NCT05118776

First Posted

October 26, 2021

Last Updated

June 28, 2022

Sponsor

Ascletis Pharmaceuticals Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT05118776

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2022

Overall Recruitment Status

Recruiting

Study Start Date

January 21, 2022 (Actual)

Primary Completion Date

July 16, 2023 (Anticipated)

Study Completion Date

September 16, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Ascletis Pharmaceuticals Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Recurrent Glioblastoma

Keywords

ASC40, Recurrent Glioblastoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

ASC40

Arm Type

Experimental

Arm Description

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

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo and bevacizumab 10mg/kg.

Intervention Type

Drug

Intervention Name(s)

ASC40 tablets

Other Intervention Name(s)

TVB-2640

Intervention Description

ASC40 tablets administered orally once daily

Intervention Type

Drug

Intervention Name(s)

Placebo tablets

Intervention Description

Placebo administered orally once daily.

Intervention Type

Drug

Intervention Name(s)

Bevacizumab

Intervention Description

Bevacizumab once every 2 weeks, intravenous drip.

Primary Outcome Measure Information:

Title

Progression-free survival

Description

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])

Time Frame

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

Title

Total survival

Description

the time from random grouping to death, compared with the control group.

Time Frame

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 Measure Information:

Title

Objective remission rate

Description

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]).

Time Frame

Week 4 to Month 6 (every 8 weeks)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Wenbin Li, Doctor

Phone

86-010-59975034

neure55@126.com

First Name & Middle Initial & Last Name or Official Title & Degree

Zhuang Kang, Master

Phone

86-010-59975034

kzhaoren1984@163.com

Facility Information:

Facility Name

Beijing Tiantan Hospital，Capital Medical University

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100071

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Wenbin Li

Phone

+861059975034

neure55@126.com

First Name & Middle Initial & Last Name & Degree

Zhuang Kang

Phone

+861059975034

kzhaoren1984@163.com

First Name & Middle Initial & Last Name & Degree

Wenbin Li, Doctor

12. IPD Sharing Statement

Learn more about this trial

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

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