Poly ICLC

Phase 2Small molecule

CCelldex Therapeutics

Poly ICLC is one of 520 small molecule programs targeting Glioma. It is currently in Phase 2.

Indications

Total Trials

Active Trials

519

Competitors

Pipeline

Status by Indication[3][1]

Indication

GliomaActive, not recruiting

LymphomaActive, not recruiting

Triple-Negative Breast CancerActive, not recruiting

Liver CancerActive, not recruiting

Pancreatic AdenocarcinomaActive, not recruiting

Low Grade GliomaActive, not recruiting

Myelodysplastic SyndromeActive, not recruiting

Non-Small Cell Lung CancerActive, not recruiting

Breast CancerActive, not recruiting

MelanomaActive, not recruiting

GliomaPhase 1

Active, not recruiting

LymphomaPhase 1/Phase 2

Active, not recruiting

Triple-Negative Breast CancerPhase 1

Active, not recruiting

Liver CancerPhase 1/Phase 2

Active, not recruiting

Pancreatic AdenocarcinomaPhase 1

Active, not recruiting

Low Grade GliomaPhase 2

Active, not recruiting

Myelodysplastic SyndromePhase 1

Active, not recruiting

Non-Small Cell Lung CancerPhase 1

Active, not recruiting

Breast CancerPhase 2

Active, not recruiting

MelanomaPhase 2

Active, not recruiting

Showing 10 of 20 indications

Competition

Competitive Landscape

2828 competitors in Breast Cancer

#DrugCompanyPhaseTrials

Tykerb

GSK

Preclinical

80 2

Poly ICLC

CCelldex Therapeutics

Phase 2

2 3

Adriamycin

GGynecologic Oncology Group

Preclinical

87 4

Gemzar

GGynecologic Oncology Group

Preclinical

22 5

MS Contin

Merck & Co.

Preclinical

2 6

Nubain

AAultman Health Foundation

Preclinical

1 7

Paracetamol

GSK

Preclinical

1 8

QS21

MMemorial Sloan Kettering Cancer Center

Preclinical

3 9

Recombinant Human Endostatin

PPeking University Third Hospital

Preclinical

1 10

Conventional Chemotherapy

SShanghai Jiao Tong University School of Medicine

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 2Recruiting

Anatomic Stage IV Breast Cancer AJCC V8

NCT03606967

Q1 2027

Phase 1Recruiting

Myeloproliferative Neoplasm

NCT05025488

Q3 2027

Phase 1Active, not recruiting

Glioblastoma

NCT04201873

Q1 2028

Phase 1Active, not recruiting

Adjuvant

NCT05010200

Phase 1Active, not recruiting

Glioma

NCT06342908

Phase 1Active, not recruiting

Metastatic Solid Tumors

NCT04616248

Clinical

Trials by Indication[1]

Glioma6 trials

Peptide-Pulsed Dendritic Cell Vaccination in Combination With Nivolumab and Ipilimumab for the Treatment of Recurrent and/or Progressive Diffuse Hemispheric Glioma, H3 G34-mutant

Withdrawn·JJonsson Comprehensive Cancer Center·Phase 1·NCT05457959

A Study of Varlilumab and IMA950 Vaccine Plus Poly-ICLC in Patients With WHO Grade II Low-Grade Glioma (LGG)

Terminated·NNicholas Butowski·Phase 1·NCT02924038·14 enrolled

A Vaccine (Neoantigen-Targeted ppDC) for the Treatment of H3 G34-mutant Diffuse Hemispheric Glioma

Active, not recruiting·JJonsson Comprehensive Cancer Center·Phase 1·NCT06342908·6 enrolled

Show 3 more trials

A Pilot Study of Glioma Associated Antigen Vaccines in Conjunction with Poly-ICLC in Pediatric Gliomas

Completed·JJames Felker·Phase 1·NCT01130077·60 enrolled

A Phase II Trial of Poly-ICLC for Low-Grade Gliomas

Terminated·UUniversity of Alabama at Birmingham·Phase 2·NCT04544007·3 enrolled

Poly-ICLC in Treating Patients With Recurrent or Progressive Anaplastic Glioma

Completed·SSidney Kimmel Comprehensive Cancer Center at Johns Hopkins·Phase 2·NCT00058123·55 enrolled

Glioblastoma4 trials

Pembrolizumab and a Vaccine (ATL-DC) for the Treatment of Surgically Accessible Recurrent Glioblastoma

Active, not recruiting·JJonsson Comprehensive Cancer Center·Phase 1·NCT04201873·40 enrolled

Phase I/II Trial of IMA950 Multi-peptide Vaccine Plus Poly-ICLC in Glioblastoma

Completed·UUniversity Hospital, Geneva·Phase 1/2·NCT01920191·19 enrolled

Neoepitope-based Personalized Vaccine Approach in Patients With Newly Diagnosed Glioblastoma

Terminated·WWashington University School of Medicine·Phase 1·NCT02510950·1 enrolled

Show 1 more trial

Safety and Immunogenicity of Personalized Genomic Vaccine and Tumor Treating Fields (TTFields) to Treat Glioblastoma

Active, not recruiting·AAdilia Hormigo·Phase 1·NCT03223103·13 enrolled

Lymphoma3 trials

Intratumoral Poly-ICLC Plus Low Dose Local Radiation in Low Grade Recurrent B and T Cell Lymphoma

Terminated·NNevada Cancer Institute·Phase 1·NCT00880867·3 enrolled

In Situ Vaccine for Low-Grade Lymphoma: Combination of Intratumoral Flt3L and Poly-ICLC With Low-Dose Radiotherapy

Completed·JJoshua Brody·Phase 1/2·NCT01976585·21 enrolled

Poly ICLC, Radiation, and Romidepsin for Advanced Cutaneous T Cell Lymphoma

Terminated·NNYU Langone Health·Phase 1·NCT02061449·3 enrolled

Melanoma3 trials

A Phase I Study With a Personalized NeoAntigen Cancer Vaccine in Melanoma

Completed·—·Phase 1·NCT01970358·15 enrolled

A Vaccine (CDX-1401) With or Without a Biologic Drug (CDX-301) for the Treatment of Patients With Stage IIB-IV Melanoma

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT02129075·60 enrolled

A Comparison of Matured Dendritic Cells and Montanide® in Study Subjects With High Risk of Melanoma Recurrence

Completed·NNina Bhardwaj·Phase 2·NCT02334735·36 enrolled

Pancreatic Cancer2 trials

Neoantigen Vaccines in Pancreatic Cancer in the Window Prior to Surgery

Completed·WWashington University School of Medicine·Phase 1·NCT05111353·33 enrolled

Neoantigen Peptide Vaccine Strategy in Pancreatic Cancer Patients Following Surgical Resection and Adjuvant Chemotherapy

Terminated·WWashington University School of Medicine·Phase 1·NCT03956056·12 enrolled

36 more indications

Triple-Negative Breast Cancer2 trials

Safety and Immunogenicity of a Personalized Synthetic Long Peptide Breast Cancer Vaccine Strategy in Patients With Persistent Triple-Negative Breast Cancer Following Neoadjuvant Chemotherapy

Withdrawn·WWashington University School of Medicine·Phase 1·NCT02427581

MUC1 Vaccine for Triple-negative Breast Cancer

Completed·JJoseph Baar, MD, PhD·Phase 1·NCT00986609·29 enrolled

Primary Peritoneal Cancer2 trials

DEC-205/NY-ESO-1 Fusion Protein CDX-1401, Poly ICLC, and IDO1 Inhibitor INCB024360 in Treating Patients With Ovarian, Fallopian Tube, or Primary Peritoneal Cancer in Remission

Completed·RRoswell Park Cancer Institute·Phase 1/2·NCT02166905·40 enrolled

Atezolizumab, Guadecitabine, and CDX-1401 Vaccine in Treating Patients With Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Completed·NNational Cancer Institute (NCI)·Phase 1/2·NCT03206047·12 enrolled

Myelodysplastic Syndrome2 trials

DEC-205/NY-ESO-1 Fusion Protein CDX-1401and Decitabine in Treating Patients With Myelodysplastic Syndrome or Acute Myeloid Leukemia

Completed·RRoswell Park Cancer Institute·Phase 1·NCT01834248·9 enrolled

DEC-205/NY-ESO-1 Fusion Protein CDX-1401, Poly ICLC, Decitabine, and Nivolumab in Treating Patients With Myelodysplastic Syndrome or Acute Myeloid Leukemia

Completed·RRoswell Park Cancer Institute·Phase 1·NCT03358719·8 enrolled

Non-Small Cell Lung Cancer2 trials

Personalized Neo-Antigen Peptide Vaccine for the Treatment of Stage IIIC-IV Melanoma, Hormone Receptor Positive HER2 Negative Metastatic Refractory Breast Cancer or Stage III-IV Non-Small Cell Lung Cancer

Recruiting·FFred Hutchinson Cancer Center·Phase 1·NCT05098210·25 enrolled

Personalized Therapeutic Anti-tumor Vaccine With Pembrolizumab and Standard of Care Chemotherapy in Squamous Non-Small Cell Lung Cancer and Extensive Stage Small Cell Lung Cancer

Withdrawn·WWashington University School of Medicine·Phase 1·NCT03166254

Breast Cancer2 trials

Pilot Study of a Breast Cancer Vaccine Plus Poly-ICLC for Breast Cancer

Terminated·CCraig L Slingluff, Jr·Phase 1·NCT01532960·11 enrolled

Cancer Immunotherapeutic (PCI) Strategy in Triple Negative Breast Cancer Patients

Not yet recruiting·WWashington University School of Medicine·Phase 1·NCT07300475·30 enrolled

Prostate Cancer1 trial

Neoadjuvant Hiltonol® (PolyICLC) for Prostate Cancer

Completed·AAshutosh Kumar Tewari·Phase 1·NCT03262103·13 enrolled

Glioblastoma Multiforme1 trial

Biological Therapy and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme

Terminated·SSidney Kimmel Comprehensive Cancer Center at Johns Hopkins·Phase 2·NCT00052715·31 enrolled

Immunogenicity1 trial

Safety and Immunogenicity of Personalized Genomic Vaccine to Treat Malignancies

Completed·NNina Bhardwaj·Phase 1·NCT02721043·13 enrolled

Hepatocellular Carcinoma1 trial

A Phase I, Open-label Study to Assess the Safety and Efficacy of Poly-ICLC Plus Nivolumab in Unresectable Hepatocellular Carcinoma Patients

Unknown status·NNational Taiwan University Hospital·Phase 1·NCT05281926·10 enrolled

Acute Myeloid Leukemia1 trial

Vaccine Therapy and Basiliximab in Treating Patients With Acute Myeloid Leukemia in Complete Remission

Completed·UUniversity of Chicago·Phase 1·NCT01842139·7 enrolled

Terminated·CCanariaBio Inc.·Phase 1·NCT03162562·10 enrolled

Myeloproliferative Neoplasm1 trial

Mutant CALR-peptide Based Vaccine in Patients With Mutated CALR Myeloproliferative Neoplasm

Recruiting·MMarina Kremyanskaya·Phase 1·NCT05025488·10 enrolled

Pembrolizumab1 trial

Pembrolizumab + Poly-ICLC in MRP Colon Cancer

Completed·AAsha Nayak·Phase 1/2·NCT02834052·42 enrolled

Malignancies1 trial

A Study of CDX-1401 in Patients With Malignancies Known to Express NY-ESO-1

Completed·CCelldex Therapeutics·Phase 1/2·NCT00948961·70 enrolled

Urothelial Cancer1 trial

Atezolizumab Given in Combination With a Personalized Vaccine in Patients With Urothelial Cancer

Completed·MMatthew Galsky·Phase 1·NCT03359239·10 enrolled

Advanced Solid Tumor1 trial

A Trial of CDX-1401 in Combination With Poly-ICLC and Pembrolizumab, in Previously Treated Advanced Solid Tumor Patients

Withdrawn·—·Phase 1/2·NCT02661100

Follicular Lymphoma1 trial

Personalized Tumor Vaccine Strategy and PD-1 Blockade in Patients With Follicular Lymphoma

Terminated·WWashington University School of Medicine·Phase 1·NCT03121677·4 enrolled

Dendritic Cell1 trial

Study of Vaccination With Poly-ICLC and Peptide-pulsed Dendritic Cells

Terminated·MMedical University of South Carolina·Phase 1·NCT01783431·1 enrolled

Advanced Solid Tumors1 trial

Focused Ultrasound Ablation and PD-1 Antibody Blockade in Advanced Solid Tumors

Terminated·CCraig L Slingluff, Jr·Phase 1·NCT04116320·5 enrolled

Respiratory Viral Infection1 trial

Poly-ICLC to Prevent Respiratory Viral Infections A Safety Study

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1·NCT00646152·57 enrolled

Tremelimumab1 trial

A Study of Tremelimumab and IV Durvalumab Plus Poly-ICLC in Subjects With Biopsy-accessible Cancers

Completed·LLudwig Institute for Cancer Research·Phase 1/2·NCT02643303·58 enrolled

CAR1 trial

Polyinosinic-Polycytidylic Acid-poly-L-lysine Carboxymethylcellulose (Poly-ICLC) in Healthy Volunteers

Completed·RRockefeller University·Phase 1·NCT01299662·6 enrolled

Vaccination1 trial

Vaccination With Flt3L, Radiation, and Poly-ICLC

Unknown status·IIcahn School of Medicine at Mount Sinai·Phase 1/2·NCT03789097·56 enrolled

Solid Tumors1 trial

Treatment of Solid Tumors With Intratumoral Hiltonol® (Poly-ICLC)

Terminated·NNina Bhardwaj·Phase 2·NCT01984892·8 enrolled

Pancreatic Adenocarcinoma1 trial

A Study of Vaccination With Poly-ICLC and Dendritic Cells in Patients With Pancreatic Adenocarcinoma

Completed·MMedical University of South Carolina·Phase 1·NCT01677962·12 enrolled

Adjuvant1 trial

The Safety and Tolerability of PGV001-based Personalized Multi-peptide Vaccines in the Adjuvant Setting.

Active, not recruiting·AAshutosh Kumar Tewari·Phase 1·NCT05010200·27 enrolled

Metastatic Solid Tumors1 trial

In Situ Immunomodulation With CDX-301, Radiation Therapy, CDX-1140 and Poly-ICLC in Patients w/ Unresectable and Metastatic Solid Tumors

Active, not recruiting·UUniversity of Southern California·Phase 1·NCT04616248·14 enrolled

Pediatric Patients1 trial

Neoepitope-based Personalized Vaccine Approach in Pediatric Patients With Recurrent Brain Tumors

Withdrawn·WWashington University School of Medicine·Phase 1·NCT03068832

Newly Diagnosed1 trial

Personalized NeoAntigen Cancer Vaccine w RT Plus Pembrolizumab for Patients With Newly Diagnosed GBM

Recruiting·—·Phase 1·NCT02287428·56 enrolled

Low Grade Glioma1 trial

A Trial of Poly-ICLC in the Management of Recurrent Pediatric Low Grade Gliomas

Completed·WWake Forest University Health Sciences·Phase 2·NCT01188096·23 enrolled

Liver Cancer1 trial

Cyclophosphamide, Radiation Therapy, and Poly ICLC in Treating Patients With Unresectable, Recurrent, Primary, or Metastatic Liver Cancer

Unknown status·RRutgers, The State University of New Jersey·Phase 1/2·NCT00553683·50 enrolled

Anatomic Stage IV Breast Cancer AJCC v81 trial

Randomized Phase 2 Clinical Trial of Nab-Paclitaxel + Durvalumab (MEDI4736) + Tremelimumab + Neoantigen Vaccine vs. Nab-Paclitaxel + Durvalumab (MEDI4736) + Tremelimumab in Patients With Metastatic Triple Negative Breast Cancer

Recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT03606967·86 enrolled

Muscle-Invasive Bladder Carcinoma1 trial

Phase 1 Clinical Trial of a Personalized Cancer Vaccine (PCV) Strategy in Patients With Solid Tumors and Molecular Residual Disease

Recruiting·WWashington University School of Medicine·Phase 1·NCT06529822·64 enrolled

Unspecified1 trial

DCVax Plus Poly ICLC in Healthy Volunteers

Completed·RRockefeller University·Phase 1·NCT01127464·43 enrolled

Sources

References

[1]
ClinicalTrials.gov — 59 trial records for Poly ICLC. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Poly ICLC compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Poly ICLC. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Celldex Therapeutics company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 2[1]
Company: CCelldex Therapeutics

Poly ICLC

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q1 2027

Q3 2027

Q1 2028

Trials by Indication[1]

Glioma6 trials

Glioblastoma4 trials

Lymphoma3 trials

Melanoma3 trials

Pancreatic Cancer2 trials

Triple-Negative Breast Cancer2 trials

Primary Peritoneal Cancer2 trials

Myelodysplastic Syndrome2 trials

Non-Small Cell Lung Cancer2 trials

Breast Cancer2 trials

Prostate Cancer1 trial

Glioblastoma Multiforme1 trial

Immunogenicity1 trial

Hepatocellular Carcinoma1 trial

Acute Myeloid Leukemia1 trial

Immune Checkpoint Inhibitor1 trial

Radiation Therapy1 trial

Ovarian Cancer1 trial

Myeloproliferative Neoplasm1 trial

Pembrolizumab1 trial

Malignancies1 trial

Urothelial Cancer1 trial

Advanced Solid Tumor1 trial

Follicular Lymphoma1 trial

Dendritic Cell1 trial

Advanced Solid Tumors1 trial

Respiratory Viral Infection1 trial

Tremelimumab1 trial

CAR1 trial

Vaccination1 trial

Solid Tumors1 trial

Pancreatic Adenocarcinoma1 trial

Adjuvant1 trial

Metastatic Solid Tumors1 trial

Pediatric Patients1 trial

Newly Diagnosed1 trial

Low Grade Glioma1 trial

Liver Cancer1 trial

Anatomic Stage IV Breast Cancer AJCC v81 trial

Muscle-Invasive Bladder Carcinoma1 trial

Unspecified1 trial

References

Drug Info

Quick Facts

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