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

NCT05118776 | Active Not Recruiting Phase 3

• 1 other identifier: ASC40-301
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 1

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

Keywords

ASC40; Recurrent Glioblastoma

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Objective remission rate

  Week 4 to Month 6 (every 8 weeks)

Study Arms (2)

ASC40

EXPERIMENTAL

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

Drug: ASC40 tablets; Drug: Bevacizumab

Placebo

PLACEBO COMPARATOR

Placebo and bevacizumab 10mg/kg.

Drug: Placebo tablets; Drug: Bevacizumab

Interventions

ASC40 tablets DRUG

ASC40 tablets administered orally once daily

Also known as: TVB-2640

ASC40

Placebo tablets DRUG

Placebo administered orally once daily.

Placebo

Bevacizumab DRUG

Bevacizumab once every 2 weeks, intravenous drip.

ASC40; Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Age ≥18 years old, both male and female;
• \. Histologically confirmed glioblastoma;
• \. 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.

You may not qualify if:

• \. Use low molecular weight heparin and warfarin within 35 days before randomization;
• \. 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

Sponsors & Collaborators

• Ascletis Pharmaceuticals Co., Ltd.: lead

Study Sites (1)

Beijing Tiantan Hospital，Capital Medical University

Beijing, Beijing Municipality, 100071, China

Location

MeSH Terms

Conditions

Glioblastoma

Interventions

TVB-2640; Bevacizumab

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2021
• First Posted: November 12, 2021
• Study Start: January 21, 2022
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: October 31, 2024

Record last verified: 2024-10

Locations

CN (1)