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Virus Therapy

ACT001 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
- Double barrier contraception defined as condom with a female diaphragm
Absence of deteriorating neurological symptoms, new onset of seizures and the need for increasing doses of corticosteroids.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up tissue at surgical resection only.
Awards & highlights

Study Summary

This trial is testing a new cancer treatment that could be more effective than current treatments.

Eligible Conditions
  • Brain Tumor

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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You must use two forms of birth control, like a condom and a diaphragm, to prevent pregnancy.
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You do not have worsening neurological symptoms, new seizures, or the need for higher doses of corticosteroids.
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You are able to take care of most of your needs with occasional help.
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You are using an intrauterine device (IUD) that has a very low chance of not working (less than 1% per year).
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You should not have any major side effects from previous treatments that have not improved to a mild level (Grade 1) unless stated otherwise.
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It is possible for you to undergo another surgery if needed.

Timeline

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
This trial's timeline: 3 weeks for screening, Varies for treatment, and 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 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
1b-Dose limiting toxicities (DLTs)
1b-Incidence, type and severity of treatment-emergent AEs (TEAEs)
1b-Mean changes in Karnofsky Performance Scale score
+6 more
Secondary outcome measures
1b- Pharmacokinetics (PK) of ACT001 in Plasma concentrations in tumor.
1b-Incidence of DLTs according to the MTD/RP2D evaluation process.
2a-Concentration of ACT001 in resected tumor biopsy tissue.
+2 more

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.

Find a Location

Who is running the clinical trial?

Avance Clinical Pty Ltd.Industry Sponsor
13 Previous Clinical Trials
2,654 Total Patients Enrolled
Accendatech USA Inc.Lead Sponsor
C3 Research AssociatesUNKNOWN
2 Previous Clinical Trials
111 Total Patients Enrolled

Media Library

ACT001 (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05053880 — Phase 1 & 2
Brain Tumor Research Study Groups: 1b dose exploration, 2a- Randomized/Two-treatment Arm
Brain Tumor Clinical Trial 2023: ACT001 Highlights & Side Effects. Trial Name: NCT05053880 — Phase 1 & 2
ACT001 (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05053880 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this trial currently enrolling new participants?

"According to clinicaltrials.gov, this medical investigation is currently seeking out suitable participants. The trial was published on September 22nd 2021 and the most recent amendment occurred November 12th of the same year."

Answered by AI

What medical application is ACT001 most frequently employed for?

"ACT001 is traditionally used to treat malignant neoplasms, and has also been found effective in managing conditions such as unresectable melanoma, microsatellite instability high, or disease progression caused by chemotherapy."

Answered by AI

To what degree has ACT001 been explored in other research efforts?

"Presently, 961 clinical trials are underway to investigate ACT001 with 122 of them in the advanced Phase 3 stage. Houston is the epicentre for these studies but there are an additional 35,731 sites actively running tests related to this medication."

Answered by AI

What is the ceiling for participants in this clinical trial?

"Affirmative. The clinical trial is actively recruiting, as stated on the official website of clinicaltrials.gov which records that it was first posted in September 2021 and recently updated in November 2021. 48 participants are required across 1 site of enrollment."

Answered by AI
~14 spots leftby Mar 2025