Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06917885 | CUE-102 in Recurrent Glioblastoma | PHASE1 | RECRUITING | 18 | — | — | Jul 30, 2025 | Jan 31, 2028 | Mar 5, 2026 | 2 | United States |
A DLT is defined as any adverse event (AE) considered related to CUE-102 that meets DLT criteria in the 21-day period following the first dose of CUE-102 including pre-treatment laboratory results required for C2D1.
MTD is determined using a 3+3 design as listed in protocol section 1.1
| Arm | Type | Description |
|---|---|---|
| CUE-102 | EXPERIMENTAL | 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 |
| Name | Type | Description |
|---|---|---|
| CUE-102 | BIOLOGICAL | A WT-1-pHLA-IL2-Fc fusion protein, single-use vial, via intravenous (into the vein) infusion per protocol. |
Inclusion Criteria: * Have HLA-A\*0201 genotype as determined by genomic testing performed locally; * Have histologically confirmed World Health Organization (WHO) Grade 4 glioblastoma, other WHO grade 4 malignant glioma or molecular GBM (based on the 2021 WHO Classification) at first recurrence. P...