Evidence map›Paper›PMID 41672594›Full record

ArticleJournal for immunotherapy of cancer2026

Phase 1 open-label study of ASP9801, an oncolytic virus, in patients with advanced or metastatic solid tumors.

John L Villano, Jason J Luke, Ricklie Julian, Christos Fountzilas, Manish R Patel, Michael J Chisamore, Pranob Bhattacharya, Shigeru Takeshita, Serguei Soukharev, Shunsuke Yamada and 2 more

Abstract readClinical Trial, Phase IMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Article in Journal for immunotherapy of cancer, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

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.

2 · The registry

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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors.

John L VillanoDepartments of Medicine, Neurosurgery, and Neurology, University of Kentucky College of Medicine, Lexington, Kentucky, USA jlvillano@uky.edu.ORCID http://orcid.org/0000-0001-5583-0093
Jason J LukeUPMC Hillman Cancer Center, and Division of Malignant Hematology and Medical Oncology, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.ORCID http://orcid.org/0000-0002-1182-4908
Ricklie JulianArizona Cancer Center and Department of Medicine, University of Arizona, Tucson, Arizona, USA.
Christos FountzilasDepartment of Medicine, Roswell Park Comprehensive Cancer Center, Buffalo, New York, USA.ORCID http://orcid.org/0000-0003-3837-5644
Manish R PatelDivision of Hematology, Oncology and Transplantation, University of Minnesota, Minneapolis, Minnesota, USA.ORCID http://orcid.org/0000-0003-2752-945X
Michael J ChisamoreMerck & Co., Inc, Rahway, New Jersey, USA.
Pranob BhattacharyaAstellas Pharma Inc, Northbrook, Illinois, USA.
Shigeru TakeshitaAstellas Pharma Inc, Northbrook, Illinois, USA.
Serguei SoukharevAstellas Pharma Inc, Northbrook, Illinois, USA.
Shunsuke YamadaAstellas Pharma Inc, Tokyo, Japan.
Leshi ZhangAstellas Pharma Inc, Beijing, China.
Kristopher P WentzelThe Angeles Clinic and Research Institute, Los Angeles, California, USA.

Funding

University of Kentucky Markey Cancer Center Support Grant ECIA SupplementP30CA177558 · NCI · UNIVERSITY OF KENTUCKY · PI KATHLEEN L. O'CONNOR · 2013 to 2026
$38.3M
NCI NIH HHS P30 CA177558
6 · The paper itself

Abstract

purposeASP9801, an oncolytic virus encoding interleukin-7 and interleukin-12, was assessed for safety, tolerability, pharmacokinetics, and antitumor activity in patients with advanced solid tumors in a Phase 1 study.

methodsThe study comprised Part 1 ASP9801 monotherapy dose escalation and Part 2 dose expansion with ASP9801 monotherapy or plus pembrolizumab. Each part was divided into Groups A (ASP9801 injection into cutaneous/subcutaneous lesions) and B (ASP9801 injection into visceral lesions). Primary objectives were safety and maximum tolerated dose and/or recommended Phase 2 dose expansion (RP2D); secondary objectives included antitumor activity and pharmacokinetics.

resultsIn dose escalation, 17 and 10 patients in Groups A and B, respectively, received treatment. One dose-limiting toxicity (DLT; grade 3 cytokine release syndrome) was reported in Group A. Treatment-related adverse events (TRAEs) in ≥30% of patients in Group A were pyrexia and in Group B were pyrexia, chills, vomiting, nausea, fatigue, and headache. AEs leading to death occurred in two patients in Group A (one each for malignant neoplasm progression and sepsis); neither was attributed to ASP9801. The RP2D of ASP9801 was 5×10

conclusionsTreatment with ASP9801 alone or plus pembrolizumab was generally well tolerated; however, the study was stopped due to lack of efficacy during dose expansion.

Indexed as

NeoplasmsOncolytic VirotherapyOncolytic VirusesAdultAgedAntibodies, Monoclonal, HumanizedFemaleHumansMaleMaximum Tolerated DoseMiddle AgedNeoplasm MetastasisAntibodies, Monoclonal, HumanizedpembrolizumabImmune modulatoryOncolytic virusPharmacokinetics - PKSolid tumorTreatment related adverse event - trAE

Identifiers

PMID41672594
PMCPMC12911810

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Registered trials

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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.