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SM-1 Combined With Temozolomide in Subjects With Refractory or Recurrent High-Grade Gliomas

NCT07635173 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2026-06-09

No results posted yet for this study

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.

Conditions

Interventions

DRUG

SM-1,TMZ

This study plans to set up three independent dose cohorts in the dose escalation stage. Combined with the existing safety and pharmacokinetic data from the completed Phase I SM-1 monotherapy clinical trial, the initial dose is determined as 450 mg/day, the second intermediate dose cohort is set at 600 mg/day, and the highest planned dose cohort is 800 mg/day. A standard 3+3 dose-escalation clinical design is adopted for sequential dose escalation, with each dose cohort enrolling 3 to 6 evaluable subjects.

Sponsors & Collaborators

  • Shenzhen Zhenxing Medical Technology Co., Ltd

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-19
Primary Completion
2024-04-22
Completion
2026-03-28

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07635173 on ClinicalTrials.gov