NCT01417546

NHS-IL12 for Solid Tumors

Completed Phase 1 Last updated 18 October 2021

What this trial tests

Phase 1 trial testing NHS-IL-12 in Epithelial Neoplasms, Malignant in 72 participants. Completed in 14 October 2021.

Timeline

12 December 2011

Primary endpoint
2 June 2021

14 October 2021

Quick facts

Lead sponsor	National Cancer Institute (NCI)
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	72
Start date	12 December 2011
Primary completion	2 June 2021
Estimated completion	14 October 2021
Sites	1 location across United States

Drugs / interventions tested

• NHS-IL-12 — full drug profile →

Conditions studied

• Epithelial Neoplasms, Malignant — all drugs for Epithelial Neoplasms, Malignant →
• Epithelial Tumors, Malignant — all drugs for Epithelial Tumors, Malignant →
• Malignant Mesenchymal Tumor — all drugs for Malignant Mesenchymal Tumor →

Sponsor

National Cancer Institute (NCI)

Who can join

18 and older, any sex, with Epithelial Neoplasms, Malignant or Epithelial Tumors, Malignant. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Background:

\- The experimental drug NHS-IL12 may help the immune system become more active and kill cancer cells that have not responded to standard treatments. NHS-IL12 has been designed to cause less severe side effects than other anticancer drugs, and may be more effective. More research is needed to test NHS-IL12 in people who have solid tumors that have not responded to treatment.

Objectives:

\- To test the safety and effectiveness of NHS-IL12 as a treatment for solid tumors which have not responded to standard treatments.

Eligibility:

\- Individuals at least 18 years of age with solid tumors that have not responded to standard treatments.

Design:

* Participants will be screened with a medical history, physical exam, blood and urine tests, and imaging studies.
* Participants will receive NHS-IL12 injection every 4 weeks, and will stay in the hospital for at least one day to be monitored with frequent blood tests.
* Participants will have periodic blood samples taken before treatment and during the first week after treatment for the first two cycles. They will then have blood samples taken before treatment for the rest of the cycles.

Publications & conference data

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

1. Natural killer cells in cancer biology and therapy.
   Wu SY, Fu T, Jiang YZ, Shao ZM. · · 2020 · cited 640× · PMID 32762681 · DOI 10.1186/s12943-020-01238-x
2. New insights into IL-12-mediated tumor suppression.
   Tugues S, Burkhard SH, Ohs I, Vrohlings M, et al · · 2015 · cited 420× · PMID 25190142 · DOI 10.1038/cdd.2014.134
3. Antibody-Dependent Cellular Cytotoxicity Activity of a Novel Anti-PD-L1 Antibody Avelumab (MSB0010718C) on Human Tumor Cells.
   Boyerinas B, Jochems C, Fantini M, Heery CR, et al · · 2015 · cited 379× · PMID 26014098 · DOI 10.1158/2326-6066.cir-15-0059
4. Interleukin 12: still a promising candidate for tumor immunotherapy?
   Lasek W, Zagożdżon R, Jakobisiak M. · · 2014 · cited 366× · PMID 24514955 · DOI 10.1007/s00262-014-1523-1
5. Localized Interleukin-12 for Cancer Immunotherapy.
   Nguyen KG, Vrabel MR, Mantooth SM, Hopkins JJ, et al · · 2020 · cited 318× · PMID 33178203 · DOI 10.3389/fimmu.2020.575597
6. The tumor microenvironment in esophageal cancer.
   Lin EW, Karakasheva TA, Hicks PD, Bass AJ, et al · · 2016 · cited 245× · PMID 26923327 · DOI 10.1038/onc.2016.34
7. Overcoming Resistance to Natural Killer Cell Based Immunotherapies for Solid Tumors.
   Nayyar G, Chu Y, Cairo MS. · · 2019 · cited 135× · PMID 30805309 · DOI 10.3389/fonc.2019.00051
8. 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