Drugs / Hiltonol
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Hiltonol

Other / unclassified targets TLR3 via activation

Developed for
melanoma · breast cancer · glioblastoma · head and neck squamous cell carcinoma · oligoastrocytoma · ovarian cancer · ovarian carcinoma · primary peritoneal carcinoma
+61 more · prostate cancer · astrocytic tumor · central nervous system neoplasm · cutaneous neuroendocrine carcinoma · fallopian tube carcinoma · gastric cancer · hepatocellular carcinoma · kidney cancer · low grade glioma · malignant pancreatic neoplasm · non-small cell lung carcinoma · oligodendroglioma · primary cutaneous T-cell lymphoma · sarcoma · urinary bladder cancer · acute myeloid leukemia · acute respiratory distress syndrome · anaplastic astrocytoma · anaplastic oligoastrocytoma · biliary tract cancer · brain cancer · cancer · cervical cancer · cervical intraepithelial neoplasia · chronic myelomonocytic leukemia · colorectal cancer · COVID-19 · cutaneous melanoma · Ebola hemorrhagic fever · esophageal cancer · glioma · head and neck cancer · indolent B-cell non-Hodgkin lymphoma · influenza · liver cancer · low-grade astrocytoma · malignant glioma · malignant pleural mesothelioma · metastasis from malignant tumor of colon · metastatic malignant neoplasm · metastatic melanoma · myelodysplastic syndrome · neoplasm · neoplasm of mature B-cells · neurofibromatosis type 1 · non-Hodgkin lymphoma · pancreatic adenocarcinoma · prostate carcinoma · skin basal cell carcinoma · skin cancer · skin sarcoma · skin squamous cell carcinoma · small cell lung carcinoma · smallpox · smoldering plasma cell myeloma · squamous cell carcinoma · T-cell and NK-cell neoplasm · testicular cancer · triple-negative breast carcinoma · urothelial carcinoma · uterine adnexa cancer
Investigated by
Oncovir, Inc. · National Cancer Institute (NCI) · Celldex Therapeutics · Craig L Slingluff, Jr · Ludwig Institute for Cancer Research · Cancer Research Institute, New York City
+74 more · Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Icahn School of Medicine at Mount Sinai · Nina Bhardwaj · ANRS, Emerging Infectious Diseases · Bristol-Myers Squibb · Medical University of South Carolina · Merck Sharp & Dohme LLC · National Institute of Allergy and Infectious Diseases (NIAID) · National Institutes of Health (NIH) · Patrick Ott, MD, PhD · Rockefeller University · Roswell Park Cancer Institute · Theraclion · University of Virginia · A Glimmer of Hope Foundation · Adilia Hormigo · Asha Nayak · Ashutosh Kumar Tewari · AstraZeneca · Bay Hematology Oncology · Bay Hematology Oncology PA, Easton MD · Breast Cancer Research Foundation · CLL Topics, Inc. · CanariaBio Inc. · Carolyn Britten · Celgene Corporation · Chevy Chase Healthcare, Chevy Chase MD · Chevy Chase Regional Cancer Care Associates LLC · Children's Healthcare of Atlanta · Children's Hospital Los Angeles · Clinica Universidad de Navarra, Universidad de Navarra · Connor's Cure · Dana-Farber Cancer Institute · Dermatologic Surgery Center of Washington LLC and Skin Cancer Treatment Center · Emory University · Finn, Olivera, PhD · Frank Lieberman · French National Institute of Health and Medical Research · Ian F. Pollack, M.D. · Immatics Biotechnologies GmbH · Incyte Corporation · Inovio Pharmaceuticals · James Felker · Jennie Taylor · Jonsson Comprehensive Cancer Center · Joseph Baar, MD, PhD · Joshua Brody · Massachusetts General Hospital · MedImmune LLC · Memorial Sloan Kettering Cancer Center · Mt. Sinai School of Medicine, New York, New York · NYU Langone Health · National Taiwan University Hospital · Nevada Cancer Institute · Nicholas Butowski · NovoCure Ltd. · Nventa Biopharmaceuticals Corporation · Olivera Finn · OncoPep, Inc. · Parker Institute for Cancer Immunotherapy · Private Philanthropic Funds · Rutgers, The State University of New Jersey · The Campbell Foundation · United States Department of Defense · Unité Mixte de Service 54 Methods and Applied Research for Trials (UMS 54 MART) · University Hospital, Geneva · University of Alabama at Birmingham · University of Calgary · University of Chicago · University of Minnesota · University of Missouri-Columbia · VA Office of Research and Development · Wake Forest University Health Sciences · Washington University School of Medicine

Trials 65 · started per year

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PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 03 trials
Phase 0 NCT06472661 Sep 2024 → Aug 2026 overdue melanoma University of Virginia Recruiting No outcome recorded
Phase 0 NCT00986609 Aug 2009 → Aug 2013 inflammatory breast carcinoma, triple-negative breast carcinoma Joseph Baar, MD, PhD Completed No outcome recorded
Phase 0 NCT00795457 Jan 2009 → Feb 2013 low-grade astrocytoma, oligoastrocytoma Ian F. Pollack, M.D. Completed No outcome recorded
Phase 133 trials
Phase 1 NCT06564623 May 2025 → Mar 2029 expected biliary tract cancer Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Recruiting No outcome recorded
Phase 1 NCT06218303 Feb 2024 → Aug 2026 overdue ductal breast carcinoma in situ Finn, Olivera, PhD Recruiting No outcome recorded
Phase 1 NCT05281926 Oct 2021 → Jun 2024 hepatocellular carcinoma National Taiwan University Hospital Unknown No outcome recorded
Phase 1 NCT04672291 Jul 2021 → Apr 2023 COVID-19 Oncovir, Inc. Completed No outcome recorded
Phase 1 NCT04842682 Mar 2021 → Nov 2024 — ANRS, Emerging Infectious Diseases Completed No outcome recorded
Phase 1 NCT04024878 Nov 2020 → Apr 2025 overdue ovarian cancer Dana-Farber Cancer Institute Active not recruiting No outcome recorded
Phase 1 NCT04525859 Aug 2020 → Jun 2025 malignant pleural mesothelioma Oncovir, Inc. Completed No outcome recorded
Phase 1 NCT04116320 Nov 2019 → Aug 2023 breast cancer, cervical cancer, cutaneous neuroendocrine carcinoma, esophageal cancer +8 Craig L Slingluff, Jr Terminated No outcome recorded Stop: Enrollment
Phase 1 NCT03835533 Jun 2019 → Oct 2022 prostate carcinoma Parker Institute for Cancer Immunotherapy Completed No outcome recorded
Phase 1 NCT02950766 Mar 2019 → Dec 2027 expected kidney cancer Patrick Ott, MD, PhD Active not recruiting No outcome recorded
Phase 1/218 trials · 1 missed
Phase 1/2 NCT07113106 Jun 2025 → Oct 2026 expected — ANRS, Emerging Infectious Diseases Active not recruiting No outcome recorded
Phase 1/2 NCT06064279 Jun 2024 non-small cell lung carcinoma VA Office of Research and Development Withdrawn No outcome recorded Stop: Business
Phase 1/2 NCT03789097 Apr 2019 → Dec 2023 breast cancer, head and neck squamous cell carcinoma, non-Hodgkin lymphoma Icahn School of Medicine at Mount Sinai Completed No outcome recorded
Phase 1/2 NCT03617328 Nov 2018 → Jan 2024 melanoma Craig L Slingluff, Jr Completed No outcome recorded
Phase 1/2 NCT03721679 Sep 2018 → Jan 2021 — Oncovir, Inc. Terminated No outcome recorded Stop: Enrollment
Phase 1/2 NCT02834052 Jan 2018 → Jul 2022 metastasis from malignant tumor of colon Asha Nayak Completed No outcome recorded
Phase 1/2 NCT03206047 Nov 2017 → Nov 2020 fallopian tube carcinoma, ovarian carcinoma, primary peritoneal carcinoma National Cancer Institute (NCI) Completed No outcome recorded
Phase 1/2 NCT02643303 Dec 2016 → Feb 2022 breast cancer, cutaneous neuroendocrine carcinoma, head and neck squamous cell carcinoma, kidney cancer +6 Ludwig Institute for Cancer Research Completed No outcome recorded
Phase 1/2 NCT02425306 May 2015 → Aug 2017 melanoma Craig L Slingluff, Jr Terminated No outcome recorded Stop: Enrollment
Phase 1/2 NCT02413827 Apr 2015 → Nov 2016 metastatic melanoma Celldex Therapeutics Terminated No outcome recorded
Phase 211 trials
Phase 2 NCT04544007 Feb 2022 → Jan 2024 low grade glioma, neurofibromatosis type 1 University of Alabama at Birmingham Terminated No outcome recorded Stop: Enrollment
Phase 2 NCT02423863 Mar 2015 → Aug 2020 head and neck cancer, melanoma, sarcoma, skin cancer Oncovir, Inc. Completed No outcome recorded
Phase 2 NCT02358187 Jan 2015 → Jan 2027 expected low grade glioma James Felker Recruiting No outcome recorded
Phase 2 NCT01984892 Nov 2013 → Aug 2014 breast cancer, head and neck squamous cell carcinoma, melanoma, skin basal cell carcinoma +2 Nina Bhardwaj Terminated No outcome recorded Stop: Enrollment
Phase 2 NCT01734564 Nov 2012 → Dec 2016 neoplasm Clinica Universidad de Navarra, Universidad de Navarra Completed No outcome recorded
Phase 2 NCT01204684 Oct 2010 → Aug 2024 anaplastic astrocytoma, anaplastic oligoastrocytoma, glioblastoma Jonsson Comprehensive Cancer Center Completed No outcome recorded
Phase 2 NCT01188096 Aug 2010 → Jul 2019 brain cancer Wake Forest University Health Sciences Completed No outcome recorded
Phase 2 NCT01094496 Apr 2010 → Jul 2011 urinary bladder cancer Celldex Therapeutics Terminated No outcome recorded Stop: Enrollment
Phase 2 NCT00262730 Jan 2006 → Aug 2009 glioblastoma Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Completed No outcome recorded
Phase 2 NCT00058123 Mar 2003 → Oct 2007 central nervous system neoplasm Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Completed No outcome recorded
Comparator or background therapy61 trials
Phase 0 NCT07605520 Background May 2026 → May 2028 expected — ANRS, Emerging Infectious Diseases Recruiting No outcome recorded
Phase 0 NCT07077616 Background Jul 2025 → Dec 2027 expected glioma Biogenea Pharmaceuticals Ltd. Recruiting No outcome recorded
Phase 0 NCT00874861 Background Apr 2009 → May 2012 astrocytoma (excluding glioblastoma), oligoastrocytoma, oligodendroglioma Ian F. Pollack, M.D. Completed No outcome recorded
Phase 1 NCT07300475 Background Oct 2026 → Jul 2030 expected triple-negative breast carcinoma Washington University School of Medicine Not yet recruiting No outcome recorded
Phase 1 NCT07430202 Background Oct 2026 → Oct 2030 expected fibrolamellar hepatocellular carcinoma Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Recruiting No outcome recorded

News releases announcing trial results or a regulatory action · 1

DateIssuerRelease
2012-12-20 Gliknik Inc. Results Gliknik Announces Interim Clinical Data From Use of Its Immunomodulator Drug Candidate in Multiple Myeloma Patients gliknik.com ↗
Based on the interim analysis, researchers saw a 180-day rate of complete or partial response of 96 percent.

All press releases naming this drug 1 release

DateIssuerRelease

Evidence & citations 18 cited values

Every value below carries the sentence it was read from. 135 sources stand behind the page.

FieldValueCited text
Known as Hiltonol “The purpose of this study is to test an approach of stimulating the body's immune system to attack prostate cancer. This study will test injection of a substance polylysine and...” NCT03262103 ↗
32

“In a recently concluded phase 1 study of CDX-1401 in combination with adjuvant Toll-like receptor agonists with Resiquimod (TLR7/8 agonist) and Hiltonol (poly-ICLC; TLR3...” NCT02661100 ↗

“Study of the Immunogenicity of the MUC1 Peptide - Poly-ICLC (Polyinosinic-polycytidylic Acid Stabilized With Polylysine and Carboxymethylcellulose) OR HILTONOL™ Adjuvant...” NCT01720836 ↗

“inject a body defense activator, polyinosinic-polycytidylic acid polylysine carboxymethylcellulose (poly ICLC, hiltonol, oncovir), into and around the cancer to activate...” NCT00553683 ↗

“CD40.HIVRI.Env and Poly-ICLC (Hiltonol), respectively at 0.3 and 1.0 mg/injection, i.e. 1 ml subcutaneous route in right deltoid at weeks 0, 4 and 24” NCT04842682 ↗

“Poly-ICLC adjuvant (Hiltonol) used at a dose of 1.0 mg and will be mixed with CD40.RBDv vaccine just prior to subcutaneous injection at day 0.” NCT07605520 ↗

“Poly-ICLC (Polyinosinic-Polycytidylic acid stabilized with polylysine and carboxymethylcellulose, also known as Hiltonol®)” NCT03721679 ↗

“The potential protection of poly-ICLC (Hiltonol®) a double stranded RNA (dsRNA) against EBOV infection was assessed” PMID 30611774 ↗ Jan 2019

“The study is investigating a medication called Poly-ICLC (Hiltonol®, Oncovir), which is an adjuvant.” NCT02071095 ↗

“In the proposed clinical trial we will use poly ICLC (Hiltonol) from Oncovir, Inc as the adjuvant.” NCT01127464 ↗

“Poly-ICLC (also called Hiltonol) is an experimental "viral mimic" and an activator of immunity.” NCT02950766 ↗

Show 22 more sources

Known as Hiltinol “an experimental drug called polyICLC (polyinosinic-polycytidylic acid that is stabilized with carboxymethylcellulose and polylysine), also known as Hiltinol, that activates the...” NCT06472661 ↗
Known as Hiltonol (Poly-ICLC) “Hiltonol® (Poly-ICLC)” NCT07430202 ↗
5

“Hiltonol® (Poly-ICLC)” NCT04799431 ↗

“Hiltonol® (Poly-ICLC)” NCT06411691 ↗

“Hiltonol® (Poly-ICLC)” NCT04117087 ↗

“Hiltonol® (Poly-ICLC)” NCT04248569 ↗

“Hiltonol® (Poly-ICLC)” NCT05013216 ↗

Known as HiltonolTM “also known as HiltonolTM” NCT00374049 ↗
Known as ICLC “The adjuvant poly-interstitial Cajal-like cell (ICLC; Hiltonol) will be injected immediately after and adjacent to DC vaccine site” NCT02332889 ↗
Known as oncovir “inject a body defense activator, polyinosinic-polycytidylic acid polylysine carboxymethylcellulose (poly ICLC, hiltonol, oncovir), into and around the cancer to activate...” NCT00553683 ↗
Known as Poly ICLC: carboxymethylcellulose, polyinosinic-polycytidylic acid & poly-L-lysine double-stranded RNA “Poly ICLC: carboxymethylcellulose, polyinosinic-polycytidylic acid & poly-L-lysine double-stranded RNA” NCT01079741 ↗
Known as Poly-ICLC “The purpose of this study is to test an approach of stimulating the body's immune system to attack prostate cancer. This study will test injection of a substance polylysine and...” NCT03262103 ↗
125

“Using antigens eluted from the surface of glioblastoma samples, we designed a phase I/II study to test safety and immunogenicity of the IMA950 multipeptide vaccine adjuvanted...” PMID 30753611 ↗ Jul 2019

“This phase II study was designed to determine the objective response rate and 6-month progression free survival of adult patients with recurrent supratentorial anaplastic...” PMID 18850068 ↗ Oct 2008

“Study of the Immunogenicity of the MUC1 Peptide - Poly-ICLC (Polyinosinic-polycytidylic Acid Stabilized With Polylysine and Carboxymethylcellulose) OR HILTONOL™ Adjuvant...” NCT01720836 ↗

“The researched vaccine, containing H3.3-K27M-targeting neoantigen peptides and poly ICLC, will be administered through subcutaneous injection into DIPG patients after they...” NCT04749641 ↗

“To determine the most effective combination of autologous tumor lysate-pulsed DC vaccination, with or without the adjuvant toll-like receptor (TLR) agonists poly-ICLC or...” PMID 37790490 ↗ Sep 2023

“NY-ESO-1 recombinant protein (250 µg) was mixed with Poly-ICLC (1 mg) and Montanide ISA-51 VG (1 mL) and administered SC directly following the ipilimumab infusion every 3...” NCT01810016 ↗

“TAMAVAQ Vaccine plus Poly-ICLC, cGAMP, Granulocyte-macrophage colony stimulating factor (GM-CSF), imiquimod, CpG oligodeoxynucleotides, saponins and monophosphoryl lipid A (MPLA)” NCT07077616 ↗

“This is a phase II, prospective, longitudinal, multi-center trial of poly-ICLC (Hiltonol ®) treatment for progressive low-grade gliomas in pediatric patients with NF1.” NCT04544007 ↗

“The primary objective is to evaluate the immunogenicity of a combination of the 100mer MUC1 peptide and adjuvant Poly-ICLC in boosting the immune response to MUC1.” NCT00773097 ↗

“CD40.HIVRI.Env and Poly-ICLC (Hiltonol), respectively at 0.3 and 1.0 mg/injection, i.e. 1 ml subcutaneous route in right deltoid at weeks 0, 4 and 24” NCT04842682 ↗

Show 115 more sources

Known as Poly-ICLC (Hiltonol, Oncovir) “Poly-ICLC (Hiltonol®, Oncovir)” NCT02071095 ↗
Known as polyinosinic-polycytidylic acid “Polyinosinic-Polycytidylic acid stabilized with polylysine and carboxymethylcellulose (Poly-ICLC)” NCT00646152 ↗
1

“polyinosinic-polycytidylic acid (poly-ICLC) adjuvant” NCT05254184 ↗

Known as polyinosinic-polycytidylic acid - poly-L-lysine carboxymethylcellulose “polyinosinic-polycytidylic acid - poly-L-lysine carboxymethylcellulose (poly-ICLC)” NCT00616941 ↗
Known as polyinosinic-polycytidylic acid polylysine carboxymethylcellulose “inject a body defense activator, polyinosinic-polycytidylic acid polylysine carboxymethylcellulose (poly ICLC, hiltonol, oncovir), into and around the cancer to activate...” NCT00553683 ↗
Known as polyinosinic-polycytidylic acid stabilized with polylysine and carboxymethyl cellulose “This phase II study was designed to determine the objective response rate and 6-month progression free survival of adult patients with recurrent supratentorial anaplastic...” PMID 18850068 ↗ Oct 2008
6

“PURPOSE: This phase II study was designed to determine the overall survival time of adults with supratentorial glioblastoma treated with the immune modulator,...” PMID 18797818 ↗ Sep 2008

“Study of the Immunogenicity of the MUC1 Peptide - Poly-ICLC (Polyinosinic-polycytidylic Acid Stabilized With Polylysine and Carboxymethylcellulose) OR HILTONOL™ Adjuvant...” NCT01720836 ↗

“Polyinosinic-polycytidylic acid stabilized with polylysine and carboxymethylcellulose (poly-ICLC) (10-50 mcg/kg, administered intramuscularly one to three times weekly) was...” PMID 8727138 ↗ Jun 1996

“Poly-ICLC (Polyinosinic-Polycytidylic acid stabilized with polylysine and carboxymethylcellulose, also known as Hiltonol®)” NCT03721679 ↗

“Poly-ICLC (Polyinosinic-polycytidylic Acid Stabilized With Polylysine and Carboxymethylcellulose) or HiltonolTM” NCT00374049 ↗

“SL-701; poly-ICLC (polyinosinic-polycytidylic acid stabilized with polylysine and carboxymethyl cellulose)” NCT02078648 ↗

Known as polyinosinic-polycytidylic acid-poly-I-lysine carboxymethylcellulose “polyinosinic-polycytidylic acid-poly-I-lysine carboxymethylcellulose (poly-ICLC)” PMID 32817593 ↗ Dec 2020
Action Activate “to activate sentinel dendritic cells” NCT00553683 ↗
Modality Other / unclassified “the immunoadjuvants Montanide and polyinosinic-polycytidylic acid - poly-L-lysine carboxymethylcellulose (poly-ICLC)” NCT00616941 ↗
Route Intramuscular “patients receive poly ICLC intramuscularly 3 times weekly” NCT00052715 ↗
Target TLR3 “TLR3 agonist Poly-ICLC” NCT01079741 ↗