Evaluating Safety, Tolerability, and Preliminary Efficacy of YSCH-01 Monotherapy and in Combinati… (NCT07538128) | Clinical Trial Compass
RecruitingEarly Phase 1
Evaluating Safety, Tolerability, and Preliminary Efficacy of YSCH-01 Monotherapy and in Combination With Atezolizumab for Recurrent Glioblastoma
China10 participantsStarted 2025-01-09
Plain-language summary
The clinical study of YSCH-01 will adopt an open-label, randomized design, with a planned enrollment of 10 participants with recurrent glioblastoma. Participants will be randomly allocated to the YSCH-01 monotherapy cohort or the YSCH-01 + Atezolizumab combination cohort, with 5 participants in each cohort. The study consists of the following three phases: screening phase, treatment phase, and follow-up phase. The primary endpoint is the 1-year survival rate of participants
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Age \> 18 years, male or female.
✓. Expected survival ≥ 12 weeks.
✓. Karnofsky Performance Status (KPS) score ≥ 70 at baseline.
✓. Histopathologically confirmed glioblastoma (GBM), with first recurrence after prior surgery, chemotherapy, and/or radiotherapy.
✓. Presence of 1 contrast-enhancing tumor lesion (diameter 1-4 cm) assessed by MRI during the screening phase.
✓. Eligibility for tumor biopsy and Ommaya reservoir implantation based on hematological, hepatic, renal, and coagulation function parameters.
✓. Recovery from toxic effects of prior chemo/radiotherapy (CTCAE ≤ Grade 1, except for special cases like alopecia or pigmentation), with the Investigator determining that the corresponding adverse events (AEs) pose no safety risk.
✓. Eligible subjects of reproductive potential (male and female) must agree to use effective contraception during the trial and for at least 6 months after the last dose.
Exclusion criteria
✕. History or current evidence of another primary malignancy.
✕. Known allergy to the study drug or any of its excipients, or a history of unexplained severe allergic reactions.
✕. Any contraindication to gadolinium-enhanced MRI, such as presence of a pacemaker, infusion pump, or allergy to MRI contrast agents.
What they're measuring
1
Incidence and Nature of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Timeframe: From first dose up to 28 days after last dose
2
1-year survival rate
Timeframe: One year after receiving the first dose of YSCH-01
✕. Tumor involvement of the brainstem, cerebellum, or spinal cord; or leptomeningeal disease.
✕. MRI evidence of tumor enhancement extending to the ventricular wall, or the tumor cavity is fused with the ventricle after surgery.
✕. Preoperative MRI assessment showing the Ommaya puncture path traverses the ventricles.
✕. Active infection requiring intravenous antibiotic therapy, or unexplained fever (body temperature ≥37.5°C).
✕. Uncontrolled systemic diseases or relevant medical history, including: diabetes mellitus, cardiovascular/cerebrovascular disease (e.g., heart failure ≥NYHA Class II, hypertension ≥Grade 2, ≥First-degree atrioventricular block, history of myocardial infarction, myocarditis), pulmonary insufficiency, thyroid dysfunction, cerebral infarction within the past 6 months.