NCT02821494

Phase I Study: to Determine the Biological Activity of Two HPV16 E6 Specific Peptides Coupled to Amplivant®, a Toll-like Receptor Ligand in Patients Treated for HPV16-positive Tumors or Premalignant Lesions

Completed Phase 1 Last updated 17 February 2021

What this trial tests

Phase 1 trial testing Hespecta in Tumors or Premalignant Lesions in 25 participants. Completed in 1 March 2020.

Timeline

1 March 2015

Primary endpoint
1 March 2020

1 March 2020

Quick facts

Lead sponsor	Leiden University
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	other
Enrollment	25
Start date	1 March 2015
Primary completion	1 March 2020
Estimated completion	1 March 2020
Sites	1 location across Netherlands

Drugs / interventions tested

• Hespecta — full drug profile →

Conditions studied

• Tumors or Premalignant Lesions — all drugs for Tumors or Premalignant Lesions →

Sponsor

Leiden University

Who can join

18 and older, any sex, with Tumors or Premalignant Lesions. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Biological activity of Hespecta
  Time frame: 26 weeks
  Blood samples will be drawn and used in an array of complementary immunological assays to assess the biological activity of Hespecta. Vaccine induced immunity in the different assays is defined if the response after vaccination is at least 3-fold higher than the pre-vaccination response.

Sponsor's own description

A phase I study to establish the highest safe dose that induces HPV16 E6-specific T-cell responses, using the highly promising novel therapeutic vaccine concept named: Hespecta (HPV E Six Peptide Conjugated To Amplivant®) to induce HPV16 E6-specific T-cell responses.

Publications & conference data

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

1. Recent clinical trends in Toll-like receptor targeting therapeutics.
   Anwar MA, Shah M, Kim J, Choi S. · · 2019 · cited 209× · PMID 30450666 · DOI 10.1002/med.21553
2. Therapeutic vaccines for high-risk HPV-associated diseases.
   Chabeda A, Yanez RJR, Lamprecht R, Meyers AE, et al · · 2018 · cited 148× · PMID 29277575 · DOI 10.1016/j.pvr.2017.12.006
3. Tumor Immunity and Immunotherapy for HPV-Related Cancers.
   Shamseddine AA, Burman B, Lee NY, Zamarin D, et al · · 2021 · cited 140× · PMID 33990345 · DOI 10.1158/2159-8290.cd-20-1760
4. Cancer Vaccines, Adjuvants, and Delivery Systems.
   Paston SJ, Brentville VA, Symonds P, Durrant LG. · · 2021 · cited 139× · PMID 33859638 · DOI 10.3389/fimmu.2021.627932
5. Trial watch: Peptide-based vaccines in anticancer therapy.
   Bezu L, Kepp O, Cerrato G, Pol J, et al · · 2018 · cited 114× · PMID 30524907 · DOI 10.1080/2162402x.2018.1511506
6. Prophylactic and Therapeutic HPV Vaccines: Current Scenario and Perspectives.
   Mo Y, Ma J, Zhang H, Shen J, et al · · 2022 · cited 90× · PMID 35860379 · DOI 10.3389/fcimb.2022.909223
7. Therapeutic Vaccines for HPV-Associated Malignancies.
   Smalley Rumfield C, Roller N, Pellom ST, Schlom J, et al · · 2020 · cited 87× · PMID 33117742 · DOI 10.2147/itt.s273327
8. Toll-Like Receptors as a Therapeutic Target in the Era of Immunotherapies.
   Farooq M, Batool M, Kim MS, Choi S. · · 2021 · cited 70× · PMID 34671606 · DOI 10.3389/fcell.2021.756315