Study on the Safety and Effectiveness of ACT001 and Anti-PD-1 for Patients with Recurrent Glioblastoma Multiforme

Sponsor: Accendatech USA Inc.

Sponsor score: 0

ClinicalTrials ID:NCT05053880

This clinical trial is testing a new treatment combination of ACT001 and Pembrolizumab to see if it is safe and effective for patients with recurrent glioblastoma multiforme, a type of brain cancer that can be surgically removed.

Patient Parameters

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Program Overview

The study aims to understand how the combination of ACT001 and Pembrolizumab affects the tumor environment and the outcomes for patients with recurrent glioblastoma multiforme. Researchers will analyze the impact of these drugs on the tumor before and after surgery.

Description

This study is divided into two phases:

Phase 1b:

The goal is to find the best dose of ACT001 when combined with Pembrolizumab. Three different doses of ACT001 (200mg, 400mg, and 800mg) will be tested along with the standard dose of Pembrolizumab.
Patients will receive a single dose of both drugs about two weeks before their surgery to remove the tumor.
After surgery, a biopsy will be taken to see how the drugs affected the tumor.
Patients will continue taking ACT001 and Pembrolizumab after they recover from surgery until the tumor grows again or they experience side effects that require stopping the treatment.
A Safety Monitoring Committee will review the data to decide if it's safe to increase the dose.

Phase 2a:

Patients will be randomly assigned to receive either Pembrolizumab alone or the combination of ACT001 and Pembrolizumab.
This phase will use the dosing schedule determined in Phase 1b.

The study will help determine if this combination treatment can improve outcomes for patients with recurrent glioblastoma multiforme.

Eligibility Criteria

Inclusion Criteria

Must provide written consent to participate.
Be 18 years or older.
Have a confirmed diagnosis of glioblastoma multiforme (GBM).
Experiencing first or second relapse of GBM.
Tumor must show progression after previous treatments.
Surgery must be possible to remove the tumor.
Have a Karnofsky Performance Status of 70% or higher, meaning they can care for most of their needs.
Must be at least 4 weeks from the last cancer treatment and have recovered from any side effects.
Have a life expectancy of at least 3 months.
Have adequate organ function based on specific blood tests.
Women must not be pregnant and must use effective birth control if of childbearing potential.
Men must agree to use effective birth control if sexually active.
No worsening neurological symptoms or new seizures.
No unresolved side effects from previous treatments.
No other significant medical conditions.

Exclusion Criteria

Have an uncontrolled infection.
Have serious heart conditions or a recent stroke.
Have a disorder affecting the absorption of oral drugs.
Have untreated or unstable brain or spinal cord metastases.
Have an allergy to ACT001 or similar drugs.
Have an active autoimmune disease requiring treatment in the past 2 years.
Have a history of non-infectious lung inflammation.
Have received cancer treatments recently, except for certain bone metastases treatments.
Have used certain immune or blood vessel-targeting drugs.
Have used high doses of corticosteroids recently.
Have used other immunosuppressive treatments recently.
Have an ongoing immune deficiency or HIV.
Have unresolved side effects from previous cancer treatments.
Have had major surgery recently.
Be pregnant or breastfeeding.
Have a history of HIV or hepatitis B or C.
Have participated in another drug study recently.
Be considered unsuitable for the study by the investigator.

Locations

FACILITY	ZIP	CITY	STATE
UT MD Anderson Cancer Center, Dept of Neuro-Oncology	77030	Houston	Texas

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