Advanced Solid Tumor Clinical Trial
Official title:
A Proof-of-Concept Study to Assess the Combination of SON-1010 (IL12-FHAB) and Atezolizumab in Patients With Platinum-resistant Ovarian Cancer
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)
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 the maximum tolerated dose (MTD) of SON-1010 with a fixed dose of atezolizumab and the recommended Phase 2 dose (RP2D) 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 2 dose cohorts. This will be followed in Part 2 with an assessment in patients with PROC of the potential for improved efficacy of the combination over SON-1010 alone, vs. the standard of care (SOC). ;
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