NCT03978689

A Phase 1 Study in Patients With HPV16+ Recurrent/ Metastatic Head and Neck Squamous Cell Carcinoma

Completed Phase 1 Last updated 22 January 2026

What this trial tests

Phase 1 trial testing CUE-101 in Head and Neck Cancer in 80 participants. Completed in 4 January 2026.

Timeline

30 July 2019

Primary endpoint
4 January 2026

4 January 2026

Quick facts

Lead sponsor	Cue Biopharma
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	80
Start date	30 July 2019
Primary completion	4 January 2026
Estimated completion	4 January 2026
Sites	17 locations across United States

Drugs / interventions tested

• CUE-101 — full drug profile →
• KEYTRUDA®, Pembrolizumab

Conditions studied

• Head and Neck Cancer — all drugs for Head and Neck Cancer →
• HPV Positive Oropharyngeal Squamous Cell Carcinoma — all drugs for HPV Positive Oropharyngeal Squamous Cell Carcinoma →
• HPV-Related Carcinoma — all drugs for HPV-Related Carcinoma →

Sponsor

Cue Biopharma — full company profile →

Who can join

18 and older, any sex, with Head and Neck Cancer or HPV Positive Oropharyngeal Squamous Cell Carcinoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a multi-center, open-label, phase 1 dose escalation and expansion study evaluating the safety, anti-tumor effect, and immunogenicity of CUE-101 as monotherapy treatment in second line or CUE-101 Combination Therapy with Pembrolizumab in first line patients with HPV16+ Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC)

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Biological and clinical aspects of HPV-related cancers.
   Szymonowicz KA, Chen J. · · 2020 · cited 255× · PMID 33299640 · DOI 10.20892/j.issn.2095-3941.2020.0370
2. A systematic review of interleukin-2-based immunotherapies in clinical trials for cancer and autoimmune diseases.
   Raeber ME, Sahin D, Karakus U, Boyman O. · · 2023 · cited 139× · PMID 37004361 · DOI 10.1016/j.ebiom.2023.104539
3. Engineering cytokine therapeutics.
   Deckers J, Anbergen T, Hokke AM, de Dreu A, et al · · 2023 · cited 132× · PMID 37064653 · DOI 10.1038/s44222-023-00030-y
4. Recent Advances and Future Directions in Clinical Management of Head and Neck Squamous Cell Carcinoma.
   Muzaffar J, Bari S, Kirtane K, Chung CH. · · 2021 · cited 97× · PMID 33477635 · DOI 10.3390/cancers13020338
5. CUE-101, a Novel E7-pHLA-IL2-Fc Fusion Protein, Enhances Tumor Antigen-Specific T-Cell Activation for the Treatment of HPV16-Driven Malignancies.
   Quayle SN, Girgis N, Thapa DR, Merazga Z, et al · · 2020 · cited 51× · PMID 31964784 · DOI 10.1158/1078-0432.ccr-19-3354
6. Targeted immunotherapy against distinct cancer-associated fibroblasts overcomes treatment resistance in refractory HER2+ breast tumors.
   Rivas EI, Linares J, Zwick M, Gómez-Llonin A, et al · · 2022 · cited 49× · PMID 36085201 · DOI 10.1038/s41467-022-32782-3
7. Development of pharmacological immunoregulatory anti-cancer therapeutics: current mechanistic studies and clinical opportunities.
   Yin N, Li X, Zhang X, Xue S, et al · · 2024 · cited 48× · PMID 38773064 · DOI 10.1038/s41392-024-01826-z
8. Novel Systemic Treatment Modalities Including Immunotherapy and Molecular Targeted Therapy for Recurrent and Metastatic Head and Neck Squamous Cell Carcinoma.
   Ghosh S, Shah PA, Johnson FM. · · 2022 · cited 47× · PMID 35887235 · DOI 10.3390/ijms23147889