Last reviewed · How we verify

NCT02180698

TLR4 Agonist GLA-SE and Radiation Therapy in Treating Patients With Soft Tissue Sarcoma That Is Metastatic or Cannot Be Removed by Surgery

Completed Phase 1 Last updated 6 November 2019
What this trial tests

Phase 1 trial testing Laboratory Biomarker Analysis in Stage III Adult Soft Tissue Sarcoma in 16 participants. Completed in 7 October 2016.

Timeline
17 November 2014
Primary endpoint
7 October 2016
7 October 2016

Quick facts

Lead sponsorFred Hutchinson Cancer Center
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment16
Start date17 November 2014
Primary completion7 October 2016
Estimated completion7 October 2016
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Fred Hutchinson Cancer Center — full company profile →

Who can join

18 and older, any sex, with Stage III Adult Soft Tissue Sarcoma or Stage IV Adult Soft Tissue Sarcoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This pilot phase I clinical trial studies the side effects and best dose of toll-like receptor 4 (TLR4) agonist glucopyranosyl lipid A (GLA)-stable-emulsion (SE) when given together with radiation therapy in treating patients with soft tissue sarcoma that has spread to other parts of the body (metastatic) or cannot be removed by surgery (unresectable). TLR4 agonist GLA-SE may stimulate the immune system to kill sarcoma cells. Radiation therapy uses high energy x rays to kill tumor cells. Giving TLR4 agonist GLA-SE with radiation therapy may be a better treatment to treat sarcoma that cannot be removed by surgery.

Publications & conference data

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

  1. Toll-Like Receptor Signaling and Its Role in Cell-Mediated Immunity.
    Duan T, Du Y, Xing C, Wang HY, et al · · 2022 · cited 628× · PMID 35309296 · DOI 10.3389/fimmu.2022.812774
  2. Immunosuppressive cells in cancer: mechanisms and potential therapeutic targets.
    Tie Y, Tang F, Wei YQ, Wei XW. · · 2022 · cited 386× · PMID 35585567 · DOI 10.1186/s13045-022-01282-8
  3. Current clinical trials testing the combination of immunotherapy with radiotherapy.
    Kang J, Demaria S, Formenti S. · · 2016 · cited 293× · PMID 27660705 · DOI 10.1186/s40425-016-0156-7
  4. 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
  5. Combinations of immunotherapy and radiation in cancer therapy.
    Vatner RE, Cooper BT, Vanpouille-Box C, Demaria S, et al · · 2014 · cited 189× · PMID 25506582 · DOI 10.3389/fonc.2014.00325
  6. Trial Watch: Toll-like receptor agonists in cancer immunotherapy.
    Smith M, García-Martínez E, Pitter MR, Fucikova J, et al · · 2018 · cited 171× · PMID 30524908 · DOI 10.1080/2162402x.2018.1526250
  7. Harnessing innate immune pathways for therapeutic advancement in cancer.
    Hu A, Sun L, Lin H, Liao Y, et al · · 2024 · cited 150× · PMID 38523155 · DOI 10.1038/s41392-024-01765-9
  8. Vaccine adjuvants as potential cancer immunotherapeutics.
    Temizoz B, Kuroda E, Ishii KJ. · · 2016 · cited 149× · PMID 27006304 · DOI 10.1093/intimm/dxw015

Verify or expand the search:

Other trials of Laboratory Biomarker Analysis

Trials testing the same drug.

Other Fred Hutchinson Cancer Center trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02180698.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing