NCT05756907

Combination of SON-1010 (IL12-FHAB) and Atezolizumab in Patients With Platinum-resistant Ovarian Cancer

A Proof-of-Concept Study to Assess the Combination of SON-1010 (IL12-FHAB) and Atezolizumab in Patients With Platinum-resistant Ovarian Cancer

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Sonnet BioTherapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 1b/2a, open-label, adaptive-design outpatient study to assess the safety, tolerability, and PK/PD of SON-1010 in combination with atezolizumab administered to patients with advanced solid tumors (Part 1) and patients with Platinum-resistant Ovarian Cancer (Part 2)

Detailed description

SON-1010 may work best with an immune checkpoint inhibitor (ICI), particularly with tumors that are high in the 'secreted protein acidic and rich in cysteine' (SPARC), like ovarian cancer. Immunotherapy combinations can present different toxicities, so a dose of SON-1010 above the rhIL-12 MTD, along with a fixed dose of atezolizumab, will initially be established in patients with advanced solid tumors in Part 1, with the subset of patients with platinum-resistant ovarian cancer (PROC) used in the top 3 dose cohorts. An expansion cohort will establish the potential to move to Phase 2 using Simon criteria. If acceptable, this will be followed in Part 2 with an assessment in patients with PROC of the potential for improved efficacy of the combination of SON-1010 with atezolizumab vs. the standard of care (SOC).

Conditions

• Advanced Solid Tumor
• Platinum-resistant Ovarian Cancer

Interventions

Type	Name	Description
BIOLOGICAL	SON-1010	SON-1010 + Atezolizumab

Timeline

• Start date: 2023-09-15
• Primary completion: 2025-12-31
• Completion: 2026-01-08
• First posted: 2023-03-07
• Last updated: 2026-02-03

Locations

6 sites across 2 countries: United States, Australia

Regulatory

• FDA-regulated drug study