A phase I trial of LHC165 single agent and in combination with spartalizumab in patients with advanced solid malignancies.

ABSTRACT:

Background

LHC165 is a Toll-like receptor (TLR)-7 agonist that generates an effective tumor antigen-specific T-cell adaptive immune response as well as durable antitumor responses. We aimed to evaluate the safety, tolerability, efficacy, dose-limiting toxicities, and pharmacokinetics (PK) of LHC165 single agent (SA) ± spartalizumab [PDR001; anti-programmed cell death protein 1 (PD-1)] in adult patients with advanced solid tumors.

Materials and methods

In this phase I/Ib, open-label, dose-escalation/expansion study, patients received LHC165 SA 100-600 μg biweekly through intratumoral (IT) injection and LHC165 600 μg biweekly + spartalizumab 400 mg Q4W through intravenous (IV) infusion.

Results

Forty-five patients were enrolled: 21 patients received LHC165 SA, and 24 pa

SUBMITTER: Curigliano G 

PROVIDER: S-EPMC11345372 | biostudies-literature | 2024 Jul

REPOSITORIES: biostudies-literature