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

ABSTRACT:

Purpose

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.

Methods

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.

Results

In dose escalation, 17 and 10 patients in Groups A and B, respectively, received treatm

SUBMITTER: Villano JL 

PROVIDER: S-EPMC12911810 | biostudies-literature | 2026 Feb

REPOSITORIES: biostudies-literature