Evaluating Safety, Tolerability, and Preliminary Efficacy of YSCH-01 Monotherapy and in Combination With Atezolizumab for Recurrent Glioblastoma

Sponsor
Huashan Hospital
Study ID
NCT07538128
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • YSCH-01 — BIOLOGICAL
    Participants will receive YSCH-01 monotherapy at a dose of 5.0 × 10¹⁰ VP every 3 weeks. YSCH-01 will be administered via intratumoral or intracavitary injection through an implanted Ommaya reservoir.
  • Atezolizumab (1200 mg every three weeks) — BIOLOGICAL
    Participants will receive YSCH-01 in combination with atezolizumab every 3 weeks. YSCH-01 will be administered via intratumoral or intratumoral cavity injection through an implanted Ommaya reservoir on Day 1 of each cycle at a dose of 5.0 × 10¹⁰ viral particles (VP). Atezolizumab (PD-L1 inhibitor) will be administered via intravenous infusion on Day 8 of each cycle at a dose of 1200 mg.

Study Details

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

Key Dates

Start date
Jan 9, 2025
Status verified
Apr 2026
Primary completion
Nov 27, 2026
Completion
Feb 28, 2027

Study Design

Enrollment
10 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: YSCH-01 monotherapy
    Participants will receive YSCH-01 monotherapy administered via intratumoral or intratumoral cavity injection through an implanted Ommaya reservoir.
  • Experimental: YSCH-01 in combination with Atezolizumab
    Participants will receive YSCH-01 in combination with atezolizumab. YSCH-01 will be administered via intratumoral or intratumoral cavity injection through an implanted Ommaya reservoir, and atezolizumab will be administered intravenously.

Primary Outcome Measure

Incidence and Nature of Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: From first dose up to 28 days after last dose ]

Central Contacts

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