In this multinational dose finding Phase IIb study the efficacy and safety of two doses of AP 12009 compared to standard chemotherapy (temozolomide or PCV) is investigated in adult patients with confirmed recurrent high-grade glioma.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Histopathologically confirmed diagnosis of recurrent or refractory high-grade glioma (anaplastic astrocytoma, WHO grade III; or glioblastoma, WHO grade IV)
* Supratentorial localization
* No more than two chemotherapy regimens including radiochemotherapy since primary diagnosis
* Eligible for either TMZ or PCV treatment
* Recovery from acute toxicity caused by any previous therapy
* Adequate organ functions
* KPS at least 70%
Exclusion Criteria:
* Tumor surgery within 2 weeks prior to study entry
* Radiation therapy within 8 weeks prior to study entry
* Chemotherapy within 4 weeks prior to study entry (nitrosureas: 6 weeks)
* No more than 3 mg/day dexamethasone (or equivalent) at baseline
* Prior TGF-beta targeted therapy or tumor vaccination
* Baseline MRI shows mass effect
* Known active infection with HIV, HBV, or HCV; acute viral, bacterial, or fungal infection
* Significant psychiatric disorders/legal incapacity or a limited legal capacity
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Overall response rate of two AP 12009 dose groups and control group assessed by the evaluation of tumor size on brain MRI scans