{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,6]],"date-time":"2026-09-06T03:51:10Z","timestamp":1788666670720,"version":"build-2803163510"},"reference-count":19,"publisher":"BMJ","issue":"2","license":[{"start":{"date-parts":[[2026,2,11]],"date-time":"2026-02-11T00:00:00Z","timestamp":1770768000000},"content-version":"unspecified","delay-in-days":10,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"name":"Astellas Pharma Inc.","award":["N\/A"],"award-info":[{"award-number":["N\/A"]}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["J Immunother Cancer"],"accepted":{"date-parts":[[2025,11,13]]},"published-print":{"date-parts":[[2026,2]]},"abstract":"<jats:sec>\n                    <jats:title>Purpose<\/jats:title>\n                    <jats:p>ASP9801, 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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>The 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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      In 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 \u226530% 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\u00d710\n                      <jats:sup>8<\/jats:sup>\n                      plaque-forming unit\/mL. In Part 2 dose expansion Group A, 12 patients received monotherapy RP2D, 5 received monotherapy induction, and 2 received ASP9801 plus pembrolizumab. In Group B, 9 and 11 patients received ASP9801 monotherapy or plus pembrolizumab, respectively. One DLT occurred in Group B combination safety cohort (grade 2 pyrexia and mental status change; grade 3 hypoxia, lymphopenia, and pneumonitis). During dose expansion, TRAEs in \u226530% of any cohort (&gt;1 patient) in Group A were nausea, fatigue, chills, pyrexia, and headache and in Group B were nausea, vomiting, fatigue, chills, pyrexia, and lymphocyte count decreased. AEs led to death in two patients in Group A monotherapy and one patient in Group B monotherapy cohorts, all due to malignant neoplasm progression; none were attributed to ASP9801. One patient in Group B combination safety cohort achieved confirmed partial response (objective response rate, 9.1% (95% CI 0.3% to 52.7%)).\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Treatment with ASP9801 alone or plus pembrolizumab was generally well tolerated; however, the study was stopped due to lack of efficacy during dose expansion.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/jitc-2025-012377","type":"journal-article","created":{"date-parts":[[2026,2,11]],"date-time":"2026-02-11T16:56:59Z","timestamp":1770829019000},"page":"e012377","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":3,"title":["Phase 1 open-label study of ASP9801, an oncolytic virus, in patients with advanced or metastatic solid tumors"],"prefix":"10.1136","volume":"14","clinical-trial-number":[{"clinical-trial-number":"nct06171178","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-5583-0093","authenticated-orcid":false,"given":"John L","family":"Villano","sequence":"first","affiliation":[{"name":"Departments of Medicine, Neurosurgery, and Neurology, University of Kentucky College of Medicine, Lexington, Kentucky, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1182-4908","authenticated-orcid":false,"given":"Jason J","family":"Luke","sequence":"additional","affiliation":[{"name":"UPMC Hillman Cancer Center, and Division of Malignant Hematology and Medical Oncology, University of Pittsburgh, Pittsburgh, Pennsylvania, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ricklie","family":"Julian","sequence":"additional","affiliation":[{"name":"Arizona Cancer Center and Department of Medicine, University of Arizona, Tucson, Arizona, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3837-5644","authenticated-orcid":false,"given":"Christos","family":"Fountzilas","sequence":"additional","affiliation":[{"name":"Department of Medicine, Roswell Park Comprehensive Cancer Center, Buffalo, New York, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2752-945X","authenticated-orcid":false,"given":"Manish R","family":"Patel","sequence":"additional","affiliation":[{"name":"Division of Hematology, Oncology and Transplantation, University of Minnesota, Minneapolis, Minnesota, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael J","family":"Chisamore","sequence":"additional","affiliation":[{"name":"Merck & Co., Inc, Rahway, New Jersey, 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