NCT03799744

Safety,Tolerability,and Efficacy of VCN-01 With Durvalumab in R/M Head and Neck Squamous Cell Carcinoma

Status unknown Phase 1 Last updated 28 March 2022

What this trial tests

Phase 1 trial testing VCN-01 in Head and Neck Neoplasms in 20 participants. Status unknown.

Timeline

20 March 2019

Primary endpoint
31 January 2023

31 January 2023

Quick facts

Lead sponsor	Institut Català d'Oncologia
Phase	Phase 1
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	non randomized
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	20
Start date	20 March 2019
Primary completion	31 January 2023
Estimated completion	31 January 2023
Sites	2 locations across Spain

Drugs / interventions tested

• VCN-01 — full drug profile →
• Durvalumab — full drug profile →

Conditions studied

• Head and Neck Neoplasms — all drugs for Head and Neck Neoplasms →
• Carcinoma, Squamous Cell of Head and Neck — all drugs for Carcinoma, Squamous Cell of Head and Neck →
• Metastasis — all drugs for Metastasis →
• Recurrence — all drugs for Recurrence →

Sponsor

Institut Català d'Oncologia — full company profile →

Who can join

18 and older, any sex, with Head and Neck Neoplasms or Carcinoma, Squamous Cell of Head and Neck. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a Phase I Study to Evaluate the Safety, Tolerability, and Efficacy of VCN-01 in Combination With Durvalumab (MEDI4736) in Subjects With Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck.

VCN-01 is a genetically modified oncolytic adenovirus characterized by the presence of four independent genetic modifications on the backbone of the wild-type HAd5 adenovirus genome, encoding human PH20, that confer tumor selectivity and anti-tumor activity.

Durvalumab is a human monoclonal antibody (mAb) of the immunoglobulin G (IgG) 1 kappa subclass that inhibits binding of PD-L1.

The proposed mechanism of action (MOA) for durvalumab is interference in the interaction of PD-L1 with PD-1 and CD80 (B7.1). Blockade of PD-L1/PD-1 and PD-L1/CD80 interactions releases the inhibition of immune responses, including those that may result in tumor elimination.

Publications & conference data

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

1. Viral vector platforms within the gene therapy landscape.
   Bulcha JT, Wang Y, Ma H, Tai PWL, et al · · 2021 · cited 899× · PMID 33558455 · DOI 10.1038/s41392-021-00487-6
2. Oncolytic viruses for cancer immunotherapy.
   Hemminki O, Dos Santos JM, Hemminki A. · · 2020 · cited 246× · PMID 32600470 · DOI 10.1186/s13045-020-00922-1
3. Type I interferon-mediated tumor immunity and its role in immunotherapy.
   Yu R, Zhu B, Chen D. · · 2022 · cited 229× · PMID 35292881 · DOI 10.1007/s00018-022-04219-z
4. Oncolytic Viruses for Cancer Therapy: Barriers and Recent Advances.
   Zheng M, Huang J, Tong A, Yang H. · · 2019 · cited 213× · PMID 31872046 · DOI 10.1016/j.omto.2019.10.007
5. Recent advances of oncolytic virus in cancer therapy.
   Mondal M, Guo J, He P, Zhou D. · · 2020 · cited 154× · PMID 32078405 · DOI 10.1080/21645515.2020.1723363
6. Oncolytic Viruses: Priming Time for Cancer Immunotherapy.
   Russell L, Peng KW, Russell SJ, Diaz RM. · · 2019 · cited 93× · PMID 31321623 · DOI 10.1007/s40259-019-00367-0
7. Concepts in Oncolytic Adenovirus Therapy.
   Mantwill K, Klein FG, Wang D, Hindupur SV, et al · · 2021 · cited 75× · PMID 34638863 · DOI 10.3390/ijms221910522
8. VCN-01 disrupts pancreatic cancer stroma and exerts antitumor effects.
   Bazan-Peregrino M, Garcia-Carbonero R, Laquente B, Álvarez R, et al · · 2021 · cited 71× · PMID 35149591 · DOI 10.1136/jitc-2021-003254