Participant flow

A Study of Ad-RTS-hIL-12 + Veledimex in Pediatric Subjects With Brain Tumors Including DIPG · Source last updated 2025-08-12

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

groups

1. description

   Intratumoral Ad-RTS-hIL-12 freehand injection after tumor resection and oral veledimex (activator ligand) in pediatric patients with brain tumors. Ad-RTS-hIL-12: 2.0 x 10\^11 viral particles (vp) per injection, one intratumoral injection of Ad-RTS-hIL-12 Oral Veledimex - Arm 1 (Pediatric Brain Tumor): * Planned: 1 dose level (10mg/day) 15 oral daily doses of veledimex * Actual: All patients received 1 dose level (10 mg/day veledimex)

   id

   FG000

   title

   Arm 1 - Closed

2. description

   Intratumoral Ad-RTS-hIL-12 stereotactic injection and oral veledimex (activator ligand) in pediatric patients with DIPG. Ad-RTS-hIL-12: 2.0 x 10\^11 viral particles (vp) per injection, one intratumoral injection of Ad-RTS-hIL-12 Oral Veledimex - Arm 2 (DIPG): * Planned:2 dose levels (10mg/day, 20mg/day) * Actual: 1 patient received 5 mg/day veledimex. The other patient did not receive veledimex due to SAE.

   id

   FG001

   title

   Arm 2 - Closed

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      type

      Adverse Event

   2. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      type

      Withdrawal by Subject

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         3

      2. group Id

         FG001

         num Subjects

         3

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         3

      2. group Id

         FG001

         num Subjects

         2

      type

      Treated With Ad-RTS-hIL-12 Injection

   3. achievements

      1. group Id

         FG000

         num Subjects

         3

      2. group Id

         FG001

         num Subjects

         1

      type

      Treated With Veledimex

   4. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         2

      type

      Did Not Receive Veledimex Treatment

   5. achievements

      1. group Id

         FG000

         num Subjects

         3

      2. group Id

         FG001

         num Subjects

         1

      type

      Received Veledimex Treatment

   6. achievements

      1. group Id

         FG000

         num Subjects

         3

      2. group Id

         FG001

         num Subjects

         1

      type

      COMPLETED

   7. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         2

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

All subjects in Arm 1 received 10mg daily of veledimex. A total of three subjects were assigned to Arm 2. One subject withdrew consent prior to any study procedures on Day 0 and received no treatment. A second subject was discontinued from the study due to a Serious Adverse Event (SAE) after the Ad-RTS-hIL-12 injection but prior to receiving veledimex. The third subject received veledimex at a dose of 5 mg/day, which was the body surface area (BSA)-adjusted dose.

recruitment Details

One Arm 2 subject was screened and enrolled but consent was withdrawn prior to Day 0.

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice