Phase 1 Study of SON-1010 in Adult Patients With Advanced Solid Tumors
brief summary
This is a Phase 1, first-in-human, open-label, adaptive-design outpatient study to assess the safety, tolerability, and PK/PD of SON-1010 administered to patients with advanced solid tumors.
detailed description
This is a study of SON-1010, a single-chain human Interleukin-12 (IL12) cytokine linked to a single-chain variable region (scFv) antibody fragment, known as the fully human albumin binding domain (FHAB). The albumin binding domain moiety of SON-1010 attaches to albumin in the bloodstream, resulting in significantly enhanced drug PK properties, potentially lower risk than IL12 alone, and a broader therapeutic index. The study is designed to safely establish the Recommended Phase 2 Dose (RP2D) and/or maximum tolerated dose (MTD) with up to 6 dose-escalation groups and to expand the dataset at the maximum achieved dose (MAD) in combination with trabectedin in patients with advanced soft-tissue sarcoma.
official title
A Phase 1, Dose-Escalation Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SON-1010 (IL12-FHAB) in Adult Patients With Advanced Solid Tumors.