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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).
Study details:
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).
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 18 and older
Healthy volunteers accepted : No
Gender eligible for study: All
Things to know
Study dates
Study start: 2023-09-15
Primary completion: 2024-06-30
Study completion finish: 2025-05-30
Study type
TREATMENT
Phase
PHASE1
PHASE2
Trial ID
NCT05756907
Intervention or treatment
BIOLOGICAL: SON-1010
Conditions
- • Advanced Solid Tumor
- • Platinum-resistant Ovarian Cancer
Find a site
Closest Location:
The Border Cancer Hospital
Research sites nearby
Select from list below to view details:
The Border Cancer Hospital
Albury, New South Wales, Australia
Ashford Cancer Centre Research
Kurralta Park, South Australia, Australia
Blacktown Mt Druitt Hospital
Blacktown, New South Wales, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Participant Group/Arm | Intervention/Treatment |
---|---|
EXPERIMENTAL: Dose Level 1
| BIOLOGICAL: SON-1010
|
EXPERIMENTAL: Dose Level 2
| BIOLOGICAL: SON-1010
|
EXPERIMENTAL: Dose Level 3
| BIOLOGICAL: SON-1010
|
EXPERIMENTAL: Dose Level 4
| BIOLOGICAL: SON-1010
|
EXPERIMENTAL: Dose Level 5
| BIOLOGICAL: SON-1010
|
EXPERIMENTAL: RP2D Expansion in Patients with Platinum-resistant Ovarian Cancer
| BIOLOGICAL: SON-1010
|
EXPERIMENTAL: Randomized Arm #1 in Patients with Platinum-resistant Ovarian Cancer
| BIOLOGICAL: SON-1010
|
EXPERIMENTAL: Randomized Arm #2 in Patients with Platinum-resistant Ovarian Cancer
| BIOLOGICAL: SON-1010
|
NO_INTERVENTION: Randomized Arm #3 in Patients with Platinum-resistant Ovarian Cancer
| Not specified |
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
---|---|---|
To evaluate the safety and tolerability of SON-1010 in combination with Atezolizumab | Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 | Through study completion, an average of 1 year |
To establish the maximum tolerated dose (MTD) of SON-1010 in combination with Atezolizumab | Incidence of dose-limiting toxicities (DLTs) | Through study completion, an average of 1 year |
Secondary outcome
Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
---|---|---|
To assess the anti-tumor activity of SON-1010 dosed with atezolizumab in Platinum-resistant Ovarian Cancer (PROC), compared with SON-1010 alone or SOC therapy | Progression-free survival (PFS) | Through study completion, an average of 1 year |
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