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NCT06917885

CUE-102 in Recurrent Glioblastoma

StatusActive, Not Recruiting
PhasePhase 1
Primary completion (estimated)
Track this trial

Free. We email you which fields changed when ClinicalTrials.gov updates this record.

Record History

All 6 versions: 6 with changes below. See every version on ClinicalTrials.gov ↗

  1. Eligibility criteria expanded, about 90 words
    • Enrollment closed, study ongoing
    • Final enrollment: 12 participants (planned 18)
    • Site details revised at 2 of 2 sites
  2. Primary completion date: Jan 31, 2026 to Jan 31, 2027
    • Study completion date: Jan 31, 2027 to Jan 31, 2028
    v5
  3. Start date changed from estimate of Aug 2025 to Jul 30, 2025v4
  4. Start date: Jun 2025 to Aug 2025v3
  5. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Sep 2025 to Jun 2025
    • Site details revised at 2 of 2 sites
    v2
  6. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Number of Participants Experiencing Dose-limiting-toxicities (DLT)
Timeframe: 3 weeks
Maximum Tolerated Dose (MTD)
Timeframe: 3 weeks

Secondary (1)

Safety and tolerability

Arms and interventions

CUE-102Experimental

The first 12 participants will be enrolled using a standard 3 + 3 design in a safety lead-in to determine the maximum tolerated dose (MTD) of CUE-102 per protocol. Once the MTD has been determined, up to 6 additional participants will be enrolled in a dose expansion cohort. Participants will complete: * Baseline visit * Imaging every 9 weeks starting at Cycle 3 * Cycle 1 through End of Treatment (up to 1 year in total, approximately 17 cycles) --Day 1 of 21 day cycle: Predetermined dose of CUE-102 1x daily. * End of Treatment visit with imaging * Long-Term Follow Up: every 3-4 months

Biologicals: CUE-102

Sites

2 sites in 1 country