Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
CUE-101 · 3 trials · 7 indications
This outcome measure evaluates the immune response by quantifying the presence of HPV-16 E711-20-specific CD8+ T cells in the peripheral blood at the conclusion of neoadjuvant treatment. The assessment will involve collecting blood samples from participants and analyzing them for the presence and quantity of these specific CD8+ T cells using immunological assays. The primary endpoint is the change in the number of HPV-16 E711-20-specific CD8+ T cells from baseline to the end of the treatment period.
-Defined as \>7 days of treatment-related delay from the planned date of surgery or initiation of definitive-chemoradiation therapy.
* Determined by IFN γ ELISpot for detection of HPV16 E711-20-specific T cells * Baseline, prior to each CUE-101 infusion, 24 hours post-end of each CUE-101 infusion, prior to standard of care therapy, at day 28 post CUE-101, 2 month follow-up, 4 month follow-up, 8 month follow-up and 12 month follow-up
* Determined by multiparameter flow cytometry * Baseline, prior to each CUE-101 infusion, 24 hours post-end of each CUE-101 infusion, prior to standard of care therapy, at day 28 post CUE-101, 2 month follow-up, 4 month follow-up, 8 month follow-up and 12 month follow-up
The number of subjects who have dose limiting toxicities (DLTs), defined as clinically significant or ≥ Grade 3 Common Terminology Criteria for Adverse Events (CTCAE) v5.0, changes in adverse events (AEs), safety laboratory tests, physical examinations, electrocardiograms (ECGs), or vital signs
Area under the concentration-time curve (AUC) of CUE-101
| Arm | Type | Description |
|---|---|---|
| Neoadjuvant CUE-101 | EXPERIMENTAL | Neoadjuvant therapy followed by definitive surgical resection |
| Neoadjuvant Pembro | EXPERIMENTAL | Pembrolizumab Neoadjuvant therapy followed by definitive surgical resection |
| Neoadjuvant CUE-101 + Pembro | EXPERIMENTAL | CUE-101+Pembrolizumab as neoadjuvant therapy followed by definitive surgical resection |
| Schedule A: CUE-101 | EXPERIMENTAL | * In Schedule A, CUE-101 will be administered during the neoadjuvant phase as a single dose given 14 days prior to initiation of standard of care (SOC) therapy. * Standard of care therapy consists of surgery and postoperative adjuvant (cisplatin) and radiation therapy or cisplatin and radiation therapy (definitive-chemoradiation therapy) |
| Schedule B: CUE-101 | EXPERIMENTAL | * In Schedule B, CUE-101 will be administered during the neoadjuvant phase as two doses: one dose given 14 days and one dose given 7 days prior to initiation of standard of care (SOC) therapy. * Standard of care therapy consists of surgery and postoperative adjuvant (cisplatin) and radiation therapy or cisplatin and radiation therapy (definitive-chemoradiation therapy) |
| Schedule C: CUE-101 | EXPERIMENTAL | * In Schedule C, CUE-101 will be administered during the neoadjuvant phase as a single dose given 7 days prior to initiation of standard of care (SOC) therapy. * Standard of care therapy consists of surgery and postoperative adjuvant (cisplatin) and radiation therapy or cisplatin and radiation therapy (definitive-chemoradiation therapy) |
| CUE-101 dose escalation and expansion | EXPERIMENTAL | Part A\&B: CUE-101 Monotherapy IV infusion Q3W Dose Escalation (Part A) and Expansion (Part B) |
| Pembrolizumab and CUE-101 | OTHER | Part C\&D: CUE-101 Dose Escalation in Combination with KEYTRUDA® (pembrolizumab) for injection, for IV use 200 mg Q3W (Part C). Expansion of pembrolizumab plus CUE-101 at the combination RP2D (Part D) |
| Name | Type | Description |
|---|---|---|
| CUE-101 | DRUG | CUE-101 will be administered by IV infusion with a commercially available syringe pump or IV infusion pump over 60 minutes on Day 1 and Day 21 after all procedures and assessments are completed. It will be administered at a dosage level of 4 mg/kg x 2 |
| Pembrolizumab | DRUG | Pembrolizumab will be administered on Day 1 and Day 21 after all procedures and assessments are completed according to the Study Calendar. Pembrolizumab will be administered as a dose of 200 mg using a 30-minute (- 5 min/+10 min) IV infusion. |
| KEYTRUDA®, Pembrolizumab | DRUG | KEYTRUDA® is first-line therapy in HPV16 and HLA A\*0201-positive recurrent and/or metastatic HNSCC patients given in combination with CUE-101 in Parts C\&D according to the schedule described in the protocol. |
Inclusion Criteria: * Participants must have histologically or cytologically confirmed new diagnosis of locally advanced, non-metastatic, head and neck squamous cell carcinoma of the oropharynx (cT1-4 N0-N3 M0) * Participants must be deemed unresectable by a head and neck surgeon for one or more of...
CUE-101 is an investigational small molecule being developed for the treatment of head and neck cancer, specifically head and neck squamous cell carcinoma and oropharyngeal squamous cell carcinoma. It is being studied in patients with HPV16-positive tumors, including those with recurrent or metastatic disease and locally advanced disease.
CUE-101 targets the HPV16 E7 protein, a viral oncoprotein expressed in HPV16-positive tumors. By targeting this antigen, the drug is designed to direct the immune system against cancer cells that present HPV16 E7, potentially offering a treatment approach for HPV-related head and neck cancers.
CUE-101 is being developed by Cue Biopharma, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol CUE. The company is advancing the drug through clinical trials in the United States for the treatment of HPV16-positive head and neck cancers.
CUE-101 is in Phase 1 and Phase 2 clinical trials. It has completed a Phase 1 study and is currently being evaluated in two Phase 2 trials. The drug is investigational and has not been approved by the FDA, as it remains in active clinical development.
CUE-101 is being studied in three clinical trials: NCT03978689, a completed Phase 1 study in HPV16+ recurrent or metastatic head and neck squamous cell carcinoma; NCT04852328, a recruiting Phase 2 trial in locally advanced HPV16-positive oropharyngeal squamous cell carcinoma; and NCT07172256, a Phase 2 trial not yet recruiting, combining CUE-101 with pembrolizumab in locally advanced HPV+ head and neck cancers.
CUE-101 is the same drug in all its trials. In one ongoing Phase 2 study, NCT07172256, CUE-101 is being tested in combination with pembrolizumab for the treatment of locally advanced HPV-positive head and neck squamous cell carcinoma. This combination is being evaluated to assess the drug's effect when used alongside an immune checkpoint inhibitor.