Phase 1 first-in-human dose-escalation study of IMSA101, a novel cyclic di-nucleotide STING agonist, for patients with advanced solid tumor malignancies.

ABSTRACT:

Background

Despite progress in cancer therapeutics, there remains an unmet need for treatment of advanced solid tumors. The cGAS-cGAMP-STING pathway plays a pivotal role in innate antitumor immunity processes. IMSA101 is a small molecule analog of cGAMP and a potent STING agonist. Preclinical studies demonstrate antitumor activity of IMSA101 alone and in combination with immune-checkpoint inhibitors (ICIs).

Methods

IMSA101-101 was an open-label, multicenter, phase 1 first-in-human dose-escalation study to establish a recommended phase 2 dose (RP2D) of IMSA101 both as monotherapy and in combination with a programmed death ligand 1 (PD-(L)1)-ICI. Secondary objectives were to evaluate safety, tolerability and antitumor activity, and to characterize pharmacokinetics. Adult patie

SUBMITTER: Jacoby J 

PROVIDER: S-EPMC12182170 | biostudies-literature | 2025 Jun

REPOSITORIES: biostudies-literature