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

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ClinicalTrials.gov Identifier: NCT05118776
Recruitment Status : Recruiting
First Posted : November 12, 2021
Last Update Posted : April 3, 2024
Sponsor:
Information provided by (Responsible Party):
Ascletis Pharmaceuticals Co., Ltd.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Recurrent Glioblastoma Drug: ASC40 tablets Drug: Placebo tablets Drug: Bevacizumab Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : January 21, 2022
Estimated Primary Completion Date : December 31, 2024
Estimated Study Completion Date : December 31, 2024

Resource links provided by the National Library of Medicine

Drug Information available for: Bevacizumab

Arms and Interventions
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Arm Intervention/treatment
Experimental: ASC40
ASC40 tablets 100mg/m^2 and bevacizumab 10mg/kg.
 Drug: ASC40 tablets
ASC40 tablets administered orally once daily
Other Name: TVB-2640

Drug: Bevacizumab
Bevacizumab once every 2 weeks, intravenous drip.
Placebo Comparator: Placebo
Placebo and bevacizumab 10mg/kg.
 Drug: Placebo tablets
Placebo administered orally once daily.

Drug: Bevacizumab
Bevacizumab once every 2 weeks, intravenous drip.


Outcome Measures
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Primary Outcome Measures :
  1. Progression-free survival [ 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 ]
    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])

  2. Total survival [ 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 ]
    the time from random grouping to death, compared with the control group.


Secondary Outcome Measures :
  1. Objective remission rate [ Time Frame: 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]).


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05118776


Contacts
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Contact: Wenbin Li, Doctor 86-010-59975034 neure55@126.com
Contact: Zhuang Kang, Master 86-010-59975034 kzhaoren1984@163.com

Locations
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China, Beijing
Beijing Tiantan Hospital，Capital Medical University Recruiting
Beijing, Beijing, China, 100071
Contact: Wenbin Li    +861059975034    neure55@126.com   
Contact: Zhuang Kang    +861059975034    kzhaoren1984@163.com   
Principal Investigator: Wenbin Li, Doctor         
Sponsors and Collaborators
Ascletis Pharmaceuticals Co., Ltd.
More Information
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Responsible Party: Ascletis Pharmaceuticals Co., Ltd.
ClinicalTrials.gov Identifier: NCT05118776    
Other Study ID Numbers: ASC40-301
First Posted: November 12, 2021    Key Record Dates
Last Update Posted: April 3, 2024
Last Verified: April 2024

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Ascletis Pharmaceuticals Co., Ltd.:
ASC40
Recurrent Glioblastoma
Additional relevant MeSH terms:
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Glioblastoma
Recurrence
Disease Attributes
Pathologic Processes
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
 Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Bevacizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors