Ignite Creation Date:
2025-12-24 @ 5:19 PM
Ignite Modification Date:
2026-02-10 @ 11:56 AM
Study NCT ID:
NCT05352750
Status:
UNKNOWN
Last Update Posted:
2024-04-12
First Post:
2022-04-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase 1 Study of SON-1010 in Adult Patients With Advanced Solid Tumors
Sponsor:
Sonnet BioTherapeutics
Organization:
Study Overview
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.
Status:
UNKNOWN
Status Verified Date:
2023-07
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 and rapidly establish the Recommended Phase 2 Dose (RP2D) and/or maximum tolerated dose (MTD) with up to 5 dose-escalation groups and to expand the dataset at the recommended RP2D.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: