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Tests treatment safety and results for Recurrent Glioblastoma
Official title Evaluating Safety, Tolerability, and Preliminary Efficacy of YSCH-01 Monotherapy and in Combination With Atezolizumab for Recurrent Glioblastoma
ClinicalTrials.gov ID: NCT07538128
What this study is testing
What is YSCH-01?
YSCH-01 is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for recurrent glioblastoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Participants must meet all the following criteria to be enrolled in this study:
- 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.
You likely can't join if
- Participants with any of the following conditions are ineligible for enrollment:
- 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.
- 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.
See the full eligibility criteria
- Participants must meet all the following criteria to be enrolled in this study:
- 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...
- Eligible people 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.
- Participants with any of the following conditions are ineligible for enrollment:
- 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.
- 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...
- Active autoimmune disease or history of autoimmune disorders (e.g., ulcerative colitis, Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus, autoimmune vasculitis, Wegener's granulomatosis).
- Plan or requirement to receive any live vaccine during the screening or treatment phase.
- Other conditions assessed as incompatible with intravenous administration of Atezolizumab.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.