Treatment of Patients With Recurrent High-Grade Glioma With APG-157 and Bevacizumab

Part of paid clinical trials in Rochester, Minnesota.

Sponsor
Aveta Biomics, Inc.
Study ID
NCT06011109
Phase
PHASE1/PHASE2
Status
Recruiting

Conditions

Eligibility Criteria

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

Interventions

  • APG-157 — DRUG
    The participants will receive APG-157 daily; and continue to receive Bevacizumab as standard of care.

Study Details

The goal of this interventional study is to evaluate the efficacy of APG-157 in combination with Bevacizumab in subjects with recurrent high-grade glioma. The main questions the study aims to answer are: * Progression-free and overall survival of patients receiving this combination; * Quality of Life (QOL); and * Tumor response on imaging The participants will take APG-157 daily by dissolving two pastilles in their mouth at around breakfast, lunch and dinner time (total of six pastilles per day). The pastilles dissolve in the mouth. The participants will continue to receive Bevacizumab as standard of care.

Key Dates

Start date
Dec 13, 2023
Status verified
Jun 2026
Primary completion
Dec 31, 2026
Completion
Jun 30, 2027

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: APG-157
    The participants will receive APG-157 daily by taking two pastilles in their mouth at around breakfast, lunch and dinner time (total of six pastilles per day). The pastilles dissolve in the mouth. The participants will continue to receive Bevacizumab as standard of care.

Primary Outcome Measure

Progression-free Survival [ Time Frame: From date of commencement of treatment until the date of first documented progression or date of death from any cause, whichever comes first, assessed up to 12 months ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Mayo ClinicRochesterMinnesota55905
Joon Uhm, MD
507-284-2120
University of Nebraska Medical CenterOmahaNebraska68198
Nicole Shonka, MD
402-559-3881

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