Study Summary
This trial is testing a new drug, CUE-101, as a possible treatment for HPV16+ Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma.
- Human Papillomavirus Positive Oropharyngeal Squamous Cell Carcinoma
- Human Papillomavirus-Related Carcinoma
- Head and Neck Cancer
Treatment Effectiveness
Study Objectives
2 Primary · 1 Secondary · Reporting Duration: 36 months
Trial Safety
Side Effects for
Trial Design
1 Treatment Group
CUE-101 dose escalation and expansion
1 of 1
Experimental Treatment
85 Total Participants · 1 Treatment Group
Primary Treatment: CUE-101 · No Placebo Group · Phase 1
Trial Logistics
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age 18+ · All Participants · 10 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:- Quayle, Steven N., Natasha Girgis, Dharma R. Thapa, Zohra Merazga, Melissa M. Kemp, Alex Histed, Fan Zhao, et al.. 2020. “CUE-101, a Novel E7-phla-il2-fc Fusion Protein, Enhances Tumor Antigen-specific T-cell Activation for the Treatment of Hpv16-driven Malignancies”. Clinical Cancer Research. American Association for Cancer Research (AACR). doi:10.1158/1078-0432.ccr-19-3354.
- 2019. "A Phase 1 Study in Patients With HPV16+ Recurrent/ Metastatic Head and Neck Squamous Cell Carcinoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03978689.
Frequently Asked Questions
How many participants are actively involved in this clinical trial?
"To successfully launch the trial, Cue Biopharma needs to recruit 85 patients who meet all of the study's inclusion criteria. The sponsor will be running this clinical trial from two locations - Gabrail Cancer Center in Canton, Ohio and Affiliated Oncologists, LLC in Chicago, Illinois." - Anonymous Online Contributor
What indications does CUE-101 typically address?
"CUE-101 has been clinically validated as an effective treatment for malignant neoplasms and can also prove useful in treating conditions such as unresectable melanoma, high microsatellite instability and chemotherapy resistance." - Anonymous Online Contributor
Does CUE-101 present any risks for patients?
"Prior clinical data is sparse with respect to CUE-101's safety considerations, so this drug received a score of 1." - Anonymous Online Contributor
Are there any vacancies in this research endeavor for potential participants?
"Affirmative. Clinicaltrials.gov is host to the data that confirms this study's open recruitment, which began on July 30th 2019 and was recently revised on November 15th 2022. Seventeen sites are needed in order to enrol 85 volunteers for the trial." - Anonymous Online Contributor
How many venues are there conducting this trial?
"This clinical research trial is operating in 17 centres, such as the Gabrail Cancer Center located in Canton, Affiliated Oncologists LLC in Chicago and Barbara Karmanos Cancer Centre/Wayne State University School of Medicine based in Detroit." - Anonymous Online Contributor
Could you provide a summary of the experiments conducted with CUE-101 to date?
"CUE-101 was initially researched at City of Hope in 2010, with 249 clinical studies concluding since then. Presently, there are 963 trials actively recruiting participants; many of them taking place near Canton, Ohio." - Anonymous Online Contributor