ArticleFrontiers in immunology2022
A first-in-human phase 1 study of cavrotolimod, a TLR9 agonist spherical nucleic acid, in healthy participants: Evidence of immune activation.
Article in Frontiers in immunology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03086278 (A Randomized, Combined SAD/MAD Phase 1 Study of the Safety, Pharmacokinetics and Pharmacodynamics of AST 008 in Healthy Subjects), which is not on this map. Cited by 25 papers.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Randomized, Combined SAD/MAD Phase 1 Study of the Safety, Pharmacokinetics and Pharmacodynamics of AST 008 in Healthy Subjects
Who cites it
25 citing papers in PubMed, 30 citations in OpenAlex.
- Phase 1b/2 study evaluating safety, efficacy and immune effects of TLR9 agonist cavrotolimod with anti-PD-1 antibodies among patients with advanced solid tumors.Journal for immunotherapy of cancer · 2025Trial
- A metabolic amplification strategy for spherical nucleic acid immunogenicity driven by simvastatin-CpG codelivery.Materials today. Bio · 2026Article
- Spherical Nucleic Acids: Turning Synthetic Advances and Fundamental Discovery into Translational Breakthroughs in Chemistry, Materials Development, Biology, and Medicine.Accounts of chemical research · 2026Article
- Steering spherical nucleic acids over metabolic organs for improved targeted drug delivery.Journal of nanobiotechnology · 2026Review
- Navigating the next frontier in biomedicine: breakthroughs and insights in nucleic acid therapeutics.Chemical science · 2026Review
- E7Science advances · 2026Article
- Amphiphilic Polymeric Micelle Spherical Nucleic Acids (SNAs) as Drug Delivery Vehicles.Bioconjugate chemistry · 2026Article
- Engineering spherical nucleic acids for precision cancer therapy: design strategies and medical applications.Theranostics · 2026Review
- Structural immunotherapy: Harnessing chemical design to build powerful next-generation therapeutics.Proceedings of the National Academy of Sciences of the United States of America · 2025Article
- Progress in cancer vaccines enabled by nanotechnology.Nature nanotechnology · 2025Review
- Bioresponsive engineered nanoparticles for immunomodulation.BMC medicine · 2025Review
- A general genome editing strategy using CRISPR lipid nanoparticle spherical nucleic acids.Proceedings of the National Academy of Sciences of the United States of America · 2025Article
- Metallic nanomedicine in cancer immunotherapy.Acta pharmaceutica Sinica. B · 2025Review
- Nanotechnology for immuno-oncology.Nature cancer · 2025Review
- Hepatocyte-intrinsic innate immunity in hepatitis B virus infection: A focused review.World journal of hepatology · 2025Review
- Exploring the Subcellular Localization and Degradation of Spherical Nucleic Acids Using Fluorescence Lifetime Imaging Microscopy.ACS nano · 2025Article
- Clinical applications of oligonucleotides for cancer therapy.Molecular therapy : the journal of the American Society of Gene Therapy · 2025Review
- Enhancing immunotherapy with tumour-responsive nanomaterials.Nature reviews. Clinical oncology · 2025Review
- TLR agonists as adjuvants for viral vaccines: mechanisms, applications, and future directions.Frontiers in microbiology · 2025Review
- In Vivo Interactions of Nucleic Acid Nanostructures With Cells.Advanced materials (Deerfield Beach, Fla.) · 2025Review
Corrections and comments
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Authors and funding
4 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Introduction: Tumor immunotherapy is designed to control malignancies through the host immune response but requires circumventing tumor-dysregulated immunomodulation through immunostimulation, relieving immunorepression, or a combination of both approaches. Here we designed and characterized cavrotolimod (formerly AST-008), an immunostimulatory spherical nucleic acid (SNA) compound targeting Toll-like receptor 9 (TLR9). We assessed the safety and pharmacodynamic (PD) properties of cavrotolimod in healthy participants in a first-in-human Phase 1 study under protocol AST-008-101 (NCT03086278; https://clinicaltrials.gov/ct2/show/NCT03086278). Methods: Healthy participants aged 18 to 40 years were enrolled to evaluate four dose levels of cavrotolimod across four cohorts. Each cohort included four participants, and all received a single subcutaneous dose of cavrotolimod. The dose levels were 5, 10, 12.5 and 18.8 µg/kg. Results and discussion: Cavrotolimod was well tolerated and elicited no serious adverse events or dose limiting toxicities at the doses tested. The results demonstrated that cavrotolimod is a potent innate immune activator, specifically stimulating Th1-type immune responses, and exhibits PD properties that may result in anti-tumor effects in patients with cancer. This study suggests that cavrotolimod is a promising clinical immunotherapy agent.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.