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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
No Placebo-Only Group

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 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

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 more
Secondary study objectives
1b- Pharmacokinetics (PK) of ACT001 in Plasma concentrations in tumor.
2a-Incidence, type and severity of TEAEs
2a-Overall survival

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
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

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
~12 spots leftby Oct 2025