Clinical trial · Interventional
STAT3 DECOY in Head and Neck Cancer
Preliminary Assessment of the Safety and Biological Activity of Intratumoral STAT3 DECOY in Surgically Resectable Head and Neck Squamous Cell Carcinoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The primary goal of this study is to evaluate the safety of a transcription factor decoy targeting Signal Transducer and Activator of Transcription 3(STAT3) in patients with head and neck cancer. The rationale for targeting STAT3 using this approach is to decrease STAT3-mediated gene regulation. The study has the following scientific objectives: 1. To assess the safety of a single dose of intratumoral STAT3 decoy. 2. To estimate the effect of STAT3 decoy therapy on STAT3 activation levels, STAT3-mediated gene expression, and apoptosis in treated tumors.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| STAT 3 DECOY | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- A
- description
- STAT 3 decoy administration
- interventionNames
- Drug: STAT 3 DECOY
Primary outcomes (1)
- measure
- Evaluate the safety of a single injection.
- timeFrame
- pre and post surgery
Secondary outcomes (1)
- measure
- Evaluate the biological activity by observing the consequences of STAT3 decoy administration on STAT3 activation and target gene expression in the tumor.
- timeFrame
- pre and post surgery
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed diagnosis of head and neck squamous cell carcinoma(primary or recurrent) amenable to surgical resection. * ECOG performance status of 0, 1, or 2. * Adequate organ function * Age greater than or equal to 18 years * Written informed consent. * Patients with second primary lesions will be eligible for this trial. * Negative pregnancy test, nonlactating, and using effective means of contraception if childbearing potential. Exclusion Criteria: * Subjects who fail to meet the above criteria. * Subjects who are pregnant. * Subjects with an ECOG performance status \>2. * Subjects with tumors that are too small to biopsy prior to resection and reserve a portion of the resected specimen for research purposes. * Subjects who receive neoadjuvant radiotherapy and/or chemotherapy within four week prior to enrollment
References
Publications (1)
- DERIVEDSen M, Thomas SM, Kim S, Yeh JI, Ferris RL, Johnson JT, Duvvuri U, Lee J, Sahu N, Joyce S, Freilino ML, Shi H, Li C, Ly D, Rapireddy S, Etter JP, Li PK, Wang L, Chiosea S, Seethala RR, Gooding WE, Chen X, Kaminski N, Pandit K, Johnson DE, Grandis JR. First-in-human trial of a STAT3 decoy oligonucleotide in head and neck tumors: implications for cancer therapy. Cancer Discov. 2012 Aug;2(8):694-705. doi: 10.1158/2159-8290.CD-12-0191. Epub 2012 Jun 20. PMID 22719020