Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
CUE-102 · 2 trials · 7 indications
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
Evaluate dose-limiting toxicities (DLTs) during the first cycle of treatment with CUE-102, and to establish a recommended Phase 2 dose (RP2D)
Evaluate maximum tolerated dose (MTD) to establish a recommended Phase 2 dose (RP2D)
Area under the concentration-time curve (AUC) of CUE-102.
Maximum serum concentration (Cmax) of CUE-102.
Terminal half-life (T1/2) of CUE-102.
| 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 |
| CUE-102 (1mg/kg) Dose Escalation | EXPERIMENTAL | CUE-102 (1 mg/kg) Monotherapy IV infusion every 3 weeks for up to 2 years |
| CUE-102 (2 mg/kg) Dose Escalation | EXPERIMENTAL | CUE-102 (2 mg/kg) Monotherapy IV infusion every 3 weeks for up to 2 years |
| CUE-102 (4 mg/kg) Dose Escalation | EXPERIMENTAL | CUE-102 (4 mg/kg) Monotherapy IV infusion every 3 weeks for up to 2 years |
| CUE-102 (8 mg/kg) Dose Escalation | EXPERIMENTAL | CUE-102 (8 mg/kg) Monotherapy IV infusion every 3 weeks for up to 2 years |
| CUE-102 Dose Expansion at Determined RP2D | EXPERIMENTAL | Dose expansion of CUE-102 at determined RP2D Monotherapy IV infusion every 3 weeks for up to 2 years |
| 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...
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CUE-102 is an investigational therapy being studied in adults with recurrent glioblastoma and in recurrent or metastatic cancers, including colorectal cancer. It is being developed for patients whose tumors are HLA-A*0201 positive and WT1 positive, so enrollment in its trials depends on biomarker testing rather than tumor type alone.
CUE-102 targets WT1, the Wilms tumor 1 protein, which is expressed in several cancer types. The candidate is designed to direct an immune response against WT1-positive tumor cells, and its clinical trials select for patients who are both HLA-A*0201 positive and WT1 positive.
Cue Biopharma, Inc., which trades on the Nasdaq under the ticker CUE, is the developer of CUE-102. The company is running the program in oncology, with studies in recurrent glioblastoma and in recurrent or metastatic solid tumors.
CUE-102 is in Phase 1 clinical development. It is investigational and has not been approved by the FDA. The program includes a completed Phase 1 study in recurrent or metastatic cancers and a recruiting Phase 1 study in recurrent glioblastoma.
CUE-102 has been studied in NCT05360680, a completed Phase 1 trial in patients with HLA-A*0201 positive and WT1 positive recurrent or metastatic cancers, including colorectal, gastric, pancreatic and ovarian cancer, with 42 patients enrolled. It is also being tested in NCT06917885, a recruiting Phase 1 trial in recurrent glioblastoma with a planned enrollment of 18 patients in the United States.
NCT06917885 is recruiting adults aged 18 years and older of any sex with recurrent glioblastoma, glioma or malignant glioma. Participants must be HLA-A*0201 positive and WT1 positive, and the study is being conducted in the United States. Healthy volunteers are not eligible.