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 small molecule being studied for the treatment of colorectal cancer and recurrent glioblastoma. It is currently in Phase 1 clinical development for these oncology indications.
CUE-102 is being developed by Cue Biopharma, Inc., a biopharmaceutical company traded on NASDAQ under the ticker symbol CUE.
CUE-102 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. Clinical trials are ongoing to evaluate its safety and efficacy.
CUE-102 is being studied in two Phase 1 clinical trials. NCT05360680 is a completed study in patients with HLA-A*0201+ and WT1+ recurrent or metastatic cancers, including colorectal cancer. NCT06917885 is a recruiting study in recurrent glioblastoma.
CUE-102 is designed to target WT1, a tumor-associated antigen, in patients who are HLA-A*0201 positive. This targeting approach is being evaluated in the context of recurrent or metastatic cancers.