CM93 Treatment in Subjects With Epidermal Growth Factor Receptor (EGFR)-Modified Recurrent Gliobl… (NCT04933422) | Clinical Trial Compass
Not Yet RecruitingPhase 1
CM93 Treatment in Subjects With Epidermal Growth Factor Receptor (EGFR)-Modified Recurrent Glioblastoma (rGBM)
72 participantsStarted 2027-01
Plain-language summary
This is a first-in-human study of CM93, an oral investigational drug, in adults with Epidermal Growth Factor Receptor-modified glioblastoma. The study is designed in three parts consisting of a dose-escalation phase, a dose-expansion phase and a window-of-opportunity surgical trial. The trial objectives are to evaluate the safety, pharmacokinetics, pharmacodynamics and clinical effects of CM93 in this patient population.
Who can participate
Age range
18 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
. Have histologically confirmed recurrent or progressive World Health Organization IV isocitrate dehydrogenase (IDH) wild type glioblastoma and variants, including high-grade astrocytoma with molecular features of glioblastoma (WHO grade IV).
. Archival tumor from initial or other prior surgery is documented to have EGFR mutation or EGFR amplification
. Previous first line therapy with at least radiotherapy utilizing standard dosing of CNS radiation with or without chemotherapy.
. Patients must have shown unequivocal evidence of tumor progression by MRI and have confirmed measurable disease per RANO criteria.
. Patients must have confirmation of availability of sufficient tissue from prior surgery revealing glioblastoma or variants for submission following registration for repeat EGFR mutation testing and additional sequencing. The following amount of tissue is required:
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
Dose-limiting toxicities
Timeframe: 28 days
2
Maximum tolerated dose
Timeframe: 28 days
3
Recommended phase 2 dose
Timeframe: 28 days
4
Concentration of CM93 in non-enhancing areas of tumor
. Patients must have recovered to grade 0 or 1 as determined by the National Cancer Institute CTCAE version 5.0 or pre-treatment baseline from clinically significant toxic effects of prior therapy (including but not limited to exceptions for alopecia, laboratory values listed per inclusion criterion 3.1.12, and lymphopenia which is common after therapy with temozolomide).
. An interval of at least 4 weeks (to registration) between prior surgical resection or one week from stereotactic biopsy.
. Age ≥18 years. Because no dosing or adverse event data are currently available on the use of CM93 in participants \<18 years of age, children are excluded from this study, but will may be eligible for future pediatric trials.