AzTrials
AzTrials

Advanced Solid TumorPhase 1/2NCT05756907

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

A Phase 1/2 study testing SON-1010 in people with Advanced Solid Tumor and Platinum-resistant Ovarian Cancer, run by Sonnet BioTherapeutics at 6 sites in 2 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial 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) Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
SON-1010
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
6 sitesin 2 countries
Study dates
15 Sep 2023to 8 Jan 2026
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥18 years at the time of informed consent
  • Part 1: Must have histologically or cytologically verified solid tumors and patients must have locally advanced or metastatic disease. Must have been treated with standard of care therapies for their disease and have no standard alternative treatment options that are deemed by the treating physician to offer reasonable or potentially better benefit. Patients in cohorts C4, C5, and the RP2D expansion group must have PROC.
  • Part 2: Must have PROC, defined as recurrence of OC within 6-months (180-days) after the last dose of a platinum-containing regimen), including epithelial, fallopian tube, or 1° peritoneal carcinoma. Patients may have had one or more alternative regimen(s) before this trial, including maintenance therapy between consecutive lines of therapy. Evidence of progression and the timing of progression or reoccurrence must refer to new measurable disease by RECIST v1.1 or evaluable (non-measurable) disease. The latter is defined as not having measurable disease but has pre-study baseline values of CA125 at least 2 x ULN, with ascites and/or pleural effusion attributed to tumor OR with solid and/or cystic abnormalities on radiographic imaging consistent with recurrent disease that do not meet RECIST 1.1 definitions for target lesions.
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1.
  • Adequate organ and bone marrow function, in the absence of growth factors.
  • Females of childbearing potential, or < 1-year postmenopause who are not permanently sterile, must have a negative serum pregnancy test (beta-human chorionic gonadotropin [β-HCG]) at baseline, and agree to use 2 highly effective methods of birth control during the study and for 30 days after the last dose of study drug. Females who are not of childbearing potential (have had a tubal ligation, hysterectomy, or bilateral oophorectomy, or are ≥ 1-year postmenopause) or have a partner who has had a vasectomy do not need to use contraception. A follicle stimulating hormone (FSH) level > 35 IU/L at screening will be performed to confirm status. Refer to Section 8.2.7 for further detail.
  • Males and their female partners must use a highly effective method of birth control if female partner(s) is of childbearing potential and must not donate sperm during the study and for 90 days after the last dose of study drug.
  • Willing and able to provide signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.

Who cannot join

  • Known history of allergy to any component of study drug or a history of severe allergic/anaphylactic reaction.
  • Hospitalization for subacute bowel obstruction, other complications of the cancer, or any major surgery within 28 days prior to C1D1. Elective surgery is allowed if recovered.
  • Infection with HIV-1 or HIV-2 or a history of Kaposi sarcoma and/or Multicentric Castleman Disease.
  • Current active liver disease from any cause, including hepatitis A (hepatitis A virus IgM positive), hepatitis B (hepatitis B virus [HBV] surface antigen positive), or hepatitis C (hepatitis C virus [HCV] antibody positive, confirmed by HCV ribonucleic acid). Patients with HCV with undetectable virus after treatment are eligible (note: patients must have completed curative anti-viral therapy at least 4 weeks prior to screening). Patients with a prior history of HBV are eligible if quantitative PCR for HBV DNA is negative (note: patients must have received HBV antiviral therapy for at least 4 weeks prior to screening)
  • Pregnancy and/or lactation
  • Has received a live or live-attenuated vaccine within 30 days prior to the first dose of study drug. (Note: Administration of killed vaccines and COVID-19 vaccines that are not live or live-attenuated are allowed if > 14 days.)
Show all 27Show fewer
  • History of any active infection requiring systemic antibiotics, antivirals or antifungals, including COVID-19, within 14 days before the first dose of study drug.
  • Any acute noninfectious illness not resolved by14 days before day 1.
  • History of or known or suspected autoimmune disease (exception(s): patients with vitiligo, Type I diabetes, resolved childhood atopic dermatitis, hypothyroidism, or hyperthyroidism that is clinically euthyroid at Screening are allowed). Other exceptions may be allowed following discussion with the Sponsor Medical Monitor for patients who have not received treatment for their autoimmune disorder in the past 3 years
  • Known active central nervous system metastases and/or carcinomatous meningitis. Patients with previously treated brain metastases may participate provided they are clinically stable for at least 4 weeks prior to study entry and have no evidence of new or enlarging brain metastases.
  • Unresolved toxicities from prior anticancer therapy, defined as not resolved to baseline or to Grade 1 (NCI 2017), except for alopecia, peripheral neuropathy, and hypothyroidism secondary to prior therapy if currently being treated and clinically euthyroid.
  • Receipt of any investigational agent or treatment within 21 days or 5 half-lives, whichever is shorter, before the first dose of study drug.
  • Any prior immunotherapy or treatment with checkpoint inhibitors within a period of 5 half-lives (or 3 months, whichever is shorter) since the last dose of the therapy.
  • Use of systemic steroids > 10 mg/day prednisone (or equivalent) within 10 days of enrollment, except for local (topical, nasal, or inhaled) steroid use. Limited doses of systemic steroids (e.g., in patients with exacerbation of reactive airway disease) must have completed at least 10 days before enrollment. Steroid use to prevent IV contrast allergic reaction or anaphylaxis in patients who have known contrast allergies is allowed at any time before enrollment.
  • Active known second malignancy with the exception of any of the following:
  • Adequately treated basal cell carcinoma, squamous cell carcinoma of the skin, or in situ cervical cancer
  • Adequately treated Stage I cancer from which the patient is currently in remission and has been in remission for ≥ 2 years;
  • Low-risk prostate cancer with Gleason score < 7 and prostate-specific antigen < 10 ng/mL; or
  • Any other cancer from which the patient has been disease-free for ≥ 2 years.
  • Use of biotin (i.e., vitamin B7) or supplements containing biotin higher than the daily adequate intake of 30 μg (FDA 2019) (Note: Patients who switch from a high dose to a dose of 30 μg/day or less are eligible for study entry)
  • Any of the following within 6 months before Baseline Day 1:
  • Myocardial infarction;
  • Unstable angina;
  • Unstable symptomatic ischemic heart disease;
  • New York Heart Association (NYHA) class III or IV heart failure;
  • Thromboembolic events (e.g., deep vein thrombosis, pulmonary embolism, or symptomatic cerebrovascular events);
  • Any other significant cardiac condition (e.g., pericardial effusion, restrictive cardiomyopathy, severe untreated valvular stenosis, long QTc syndrome, or severe congenital heart disease).

Trial locations and contacts

6 sites in 2 countries.

6 sites in 2 countries

United States3 sites

  • University of Southern California

    Los Angeles, California, 90033

  • Sarcoma Oncology Center

    Santa Monica, California, 90403

  • Moffitt Cancer Center

    Tampa, Florida, 33612

Other trials in United States

Australia3 sites

  • The Border Cancer Hospital

    Albury, New South Wales, 2640

  • Blacktown Mt Druitt Hospital

    Blacktown, New South Wales, 2148

  • Ashford Cancer Centre Research

    Kurralta Park, South Australia, 5037

Other trials in Australia

About this study

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)

Read the 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).

Being tested
SON-1010

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SON-1010Biological

    SON-1010 + Atezolizumab

Study groups in NCT05756907
Study groupRoleWhat they receive
Dose Level 1ExperimentalSON-1010 Dose Level 1 + Atezolizumab
Receives: Biological: SON-1010
Dose Level 2ExperimentalSON-1010 Dose Level 2 + Atezolizumab
Receives: Biological: SON-1010
Dose Level 3ExperimentalSON-1010 Dose Level 3 + Atezolizumab
Receives: Biological: SON-1010
Dose Level 4 in Patients with Platinum-resistant Ovarian CancerExperimentalSON-1010 Dose Level 4 + Atezolizumab
Receives: Biological: SON-1010
Dose Level 5 in Patients with Platinum-resistant Ovarian CancerExperimentalSON-1010 Dose Level 5 + Atezolizumab
Receives: Biological: SON-1010
Dose Level 6 in Patients with Platinum-resistant Ovarian CancerExperimentalSON-1010 Dose Level 6 + Atezolizumab
Receives: Biological: SON-1010
DL6 Expansion in Patients with Platinum-resistant Ovarian CancerExperimentalSON-1010 Dose Level 6 + Atezolizumab
Receives: Biological: SON-1010
Dose Level 7 in Patients with Platinum-resistant Ovarian CancerExperimentalSON-1010 Dose Level 7 + Atezolizumab
Receives: Biological: SON-1010

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Through study completion, an average of 1 year

  2. To establish the maximum tolerated dose (MTD) of SON-1010 in combination with Atezolizumab

    Incidence of dose-limiting toxicities (DLTs)

    Measured: Through study completion, an average of 1 year

Secondary outcomes (1)

  1. To assess the anti-tumor activity of SON-1010 dosed with atezolizumab in Platinum-resistant Ovarian Cancer (PROC), compared with SOC therapy

    Progression-free survival (PFS)

    Measured: Through study completion, an average of 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Mar 2023
  2. Study start15 Sep 2023
  3. Primary completion31 Dec 2025
  4. Study completion8 Jan 2026

Why it stopped: Failed to meet efficacy endpoint criteria, despite lack of safety concerns

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Model description
Dose escalation and expansion
Masking
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05756907
Sponsor's protocol ID
SB221
Status last verified
Jan 2026
First submitted
23 Feb 2023
Last updated
3 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing SON-1010 in people with Advanced Solid Tumor and Platinum-resistant Ovarian Cancer, run by Sonnet BioTherapeutics at 6 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 3 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Failed to meet efficacy endpoint criteria, despite lack of safety concerns). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To evaluate the safety and tolerability of SON-1010 in combination with Atezolizumab (time frame: Through study completion, an average of 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05756907.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in