NCT05352750

Phase 1 Study of SON-1010 in Adult Patients With Advanced Solid Tumors

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.

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Sonnet BioTherapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Advanced Solid Tumor
• Soft Tissue Sarcoma Adult

Interventions

Type	Name	Description
BIOLOGICAL	SON-1010	SON-1010 is a recombinant, single-chain, unmodified human rIL-12 joined by a flexible linker to the fully human albumin binding (FHAB) domain that "hitch-hikes" on serum albumin for transport to the tumor microenvironment.

Timeline

• Start date: 2022-04-20
• Primary completion: 2026-06-30
• Completion: 2026-06-30
• First posted: 2022-04-29
• Last updated: 2026-02-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study