SM-1 Combined With Temozolomide in Subjects With Refractory or Recurrent High-Grade Gliomas (NCT07635173) | Clinical Trial Compass
CompletedPhase 1
SM-1 Combined With Temozolomide in Subjects With Refractory or Recurrent High-Grade Gliomas
China35 participantsStarted 2022-09-19
Plain-language summary
The aim of this clinical trial is to evaluate the safety, preliminary effectiveness, and pharmacokinetic profiles of SM-1 (Obitrexate Fumarate Enteric-coated Pellet Capsules) combined with temozolomide, and conduct systematic dose exploration for the treatment of refractory or recurrent high-grade gliomas in adult patients. The core focus is to screen the optimal clinical dose regimen of SM-1, fully monitor adverse reactions, and preliminarily observe the anti-tumor efficacy of the combination regimen. The main questions it aims to answer are:
* What is the safety profile and tolerability of different dose cohorts of SM-1 in combination with temozolomide in patients with refractory or recurrent high-grade gliomas?
* What are the pharmacokinetic characteristics of SM-1 across different dose levels, supporting accurate dose optimization for subsequent clinical medication?
* Can the optimized SM-1 combined regimen exert preliminary anti-tumor effectiveness in patients with refractory or recurrent high-grade gliomas, and confirm the recommended Phase II dose? Researchers will enroll eligible patients and assign them to different gradient dose groups of SM-1 for dose-escalation exploration, match with standardized temozolomide combination therapy, comprehensively collect full-cycle safety data, and preliminarily evaluate the clinical anti-tumor efficacy of different dose combinations to determine the optimal safe and effective therapeutic dose for subsequent large-scale clinical trials.
Who can participate
Age range
18 Months
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
. Voluntarily sign the informed consent form.
. Age ≥ 18 years, with no restriction on gender.
. Patients with pathologically confirmed recurrent high-grade glioma (including grade III and IV, excluding brainstem tumors) after standard therapy.
. At least 4 weeks have elapsed between major surgery (excluding puncture/biopsy) and the first dose of study drug.
. At least 3 months have elapsed between the last radiotherapy session and enrollment.
. Expected survival \> 3 months.
. KPS score ≥ 60.
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.
1Since this is a Phase 1 trial that has already completed and was primarily designed to find a safe dose of SM-1 combined with temozolomide rather than to prove it works, what do the results tell us so far about whether this combination showed any signs of benefit in people with recurrent high-grade gliomas like mine?
2The trial was specifically measuring dose-limiting toxicity — meaning a key goal was figuring out how much of SM-1 is safe alongside temozolomide — so what side effects were actually observed, and how do they compare to the risks I'd face with standard treatment options?
3Because this trial is now completed and I can no longer enroll, are there any follow-on Phase 2 trials or expanded access programs using SM-1 that I might be eligible to discuss as a next step?
4My tumor is classified as a high-grade glioma that has come back or stopped responding to treatment — given what this completed trial found, do you think the SM-1 plus temozolomide approach is something worth pursuing further, or would a different recurrent GBM trial be a better fit for my situation right now?
5Since temozolomide is already a standard chemotherapy for glioblastoma, would it make sense to try temozolomide again on its own or in a different combination before considering an experimental agent like SM-1, and how would you weigh those options for me?
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 toxicity (DLT)
Timeframe: From enrollment to the end of treatment at 4 weeks
Trial details
NCT IDNCT07635173
SponsorShenzhen Zhenxing Medical Technology Co., Ltd
. Stable or tapering dose of corticosteroids for at least 5 days prior to dosing.
Exclusion criteria
. Received any anti-cancer therapy within 28 days prior to the first dose of study drug, including radiotherapy, biological agents (antibodies, immunomodulators, cytokines, etc.), chemotherapeutic agents (subjects who received nitrosourea drugs within 42 days prior to the first dose are excluded), or traditional Chinese medicines with anti-tumor indications; or participation in any clinical study treatment within ≤28 days prior to the first dose of study drug.
. History of immunodeficiency, other acquired or congenital immunodeficiency diseases, or history of organ transplantation.
. Conditions affecting oral drug absorption, such as inability to swallow, chronic diarrhea, intestinal obstruction, etc.
. Patients with a clear bleeding tendency, e.g., gastrointestinal bleeding, hemorrhagic gastric ulcer; history of melena or hematemesis within 2 months prior to dosing; or at risk of visceral hemorrhage.
. Received hematopoietic cytokines (granulocyte colony-stimulating factor \[G-CSF\], granulocyte-macrophage colony-stimulating factor \[GM-CSF\], or erythropoietin) within 7 days prior to the first dose of study drug.
. Unresolved toxicity from prior anti-tumor therapy, i.e., not returned to baseline or Grade 0-1 per NCI CTCAE Version 5.0 (except alopecia).
. Known hypersensitivity to study drugs (SM-1 and temozolomide), their excipients, or dacarbazine.
. Known history of psychoactive substance abuse, alcoholism, or drug addiction.