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

Sponsor
Ascletis Pharmaceuticals Co., Ltd.
Study ID
NCT05118776
Phase
PHASE3
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ASC40 tablets — DRUG
    ASC40 tablets administered orally once daily
  • Placebo tablets — DRUG
    Placebo administered orally once daily.
  • Bevacizumab — DRUG
    Bevacizumab once every 2 weeks, intravenous drip.

Study Details

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.

Key Dates

First listed
Nov 12, 2021
Start date
Jan 21, 2022
Status verified
Oct 2024
Primary completion
Jun 30, 2025
Completion
Jun 30, 2025

Study Design

Enrollment
136 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: ASC40
    ASC40 tablets 100mg/m\^2 and bevacizumab 10mg/kg.
  • Placebo Comparator: Placebo
    Placebo and bevacizumab 10mg/kg.

Primary Outcome Measure

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 ]

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