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Virus Therapy
ACT001 + Pembrolizumab for Brain Tumor
Phase 1 & 2
Waitlist Available
Research Sponsored by Accendatech USA Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from start of dosing until 30 days after the last dose of act001
Awards & highlights
Summary
This trial is testing a new drug called ACT001 combined with Pembrolizumab in patients having surgery to remove tumors. The aim is to see if ACT001 can improve how well Pembrolizumab helps the immune system fight cancer. Pembrolizumab is a medication first approved by the FDA in 2014 for the treatment of advanced melanoma and is now used for various cancers including non-small-cell lung cancer.
Eligible Conditions
- Brain Tumor
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ approximately 8months/ patient.each cycle is 21 days. start at screening, pre-surgical treatment period, cycle 1 and each subsequent cycle and 30 days after last dose
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 8months/ patient.each cycle is 21 days. start at screening, pre-surgical treatment period, cycle 1 and each subsequent cycle and 30 days after last dose
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
1b-Dose limiting toxicities (DLTs)
1b-Mean changes in Karnofsky Performance Scale score
1b-Mean changes in electrocardiogram (ECG) parameters
+4 moreSecondary study objectives
1b- Pharmacokinetics (PK) of ACT001 in Plasma concentrations in tumor.
2a-Incidence, type and severity of TEAEs
2a-Overall survival
Trial Design
2Treatment groups
Experimental Treatment
Group I: 2a- Randomized/Two-treatment ArmExperimental Treatment1 Intervention
30 Patients will be randomized to Arm A or Arm B at a ratio of 1 (Arm A) : 2 (Arm B). 10 patients will be randomized to the Pembrolizumab only arm (Arm A) and 20 patients will be randomized to the ACT001 plus Pembrolizumab arm (Arm B).
Group II: 1b dose explorationExperimental Treatment1 Intervention
1b dose exploration for 18 patients - The starting dose of ACT001 will be administered in combination with a single intravenous (IV) infusion of Pembrolizumab. After recovery from surgical resection, dosing will resume on a 3 weekly cycle and will consist of Pembrolizumab (standard dosing) and daily ACT001. Evaluation of a dose level of at least three (3) patients after completing one cycle of treatment post-surgery is required prior to commencing the next dose level.
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Who is running the clinical trial?
Avance Clinical Pty Ltd.Industry Sponsor
15 Previous Clinical Trials
3,073 Total Patients Enrolled
Accendatech USA Inc.Lead Sponsor
C3 Research AssociatesUNKNOWN
2 Previous Clinical Trials
111 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You are allergic to ACT001 or similar substances.You have a history of lung inflammation that is not caused by an infection and is currently active.You are using an intrauterine device (IUD) that has a very low chance of not working (less than 1% per year).You have received previous treatment with immune checkpoint blockade (CPB) or drugs like Avastin that target blood vessels.It is possible for you to undergo another surgery if needed.The doctor believes that the patient is not suitable for the study for any other reason.You have taken a medication called everolimus, which suppresses your immune system, within the past four weeks.You must use two forms of birth control, like a condom and a diaphragm, to prevent pregnancy.You do not have worsening neurological symptoms, new seizures, or the need for higher doses of corticosteroids.You should not have any major side effects from previous treatments that have not improved to a mild level (Grade 1) unless stated otherwise.You are able to take care of most of your needs with occasional help.
Research Study Groups:
This trial has the following groups:- Group 1: 1b dose exploration
- Group 2: 2a- Randomized/Two-treatment Arm
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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