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Advanced Solid TumorPhase 1NCT05352750

Phase 1 Study of SON-1010 in Adult Patients With Advanced Solid Tumors

A Phase 1 study testing SON-1010 in people with Advanced Solid Tumor and Soft Tissue Sarcoma Adult, run by Sonnet BioTherapeutics at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. 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
42 participants
Where
1 siteUnited States
Study dates
20 Apr 2022to 30 Jun 2026
Phase
Phase 1
Are there results?
Not yet: the study is under way

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 at the time of informed consent
  • Must have histologically or cytologically verified solid epithelial or mesenchymal tumors.
  • Locally advanced or metastatic disease
  • Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST v1.1), or the modified criteria for immune-based therapeutics (termed iRECIST) as appropriate. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
  • 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, or not be a candidate for standard therapy for their disease due to an underlying physical condition. Note that if patients have alternative therapies available that are known to confer clinical benefit, they should be informed of these therapies during the informed consent process.
  • Must weigh >50 kg to ≤120 kg at screening (to facilitate SON-1010 dilution before dosing).
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  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Adequate organ and bone marrow function, in the absence of growth factors, as defined by the following laboratory parameters by day -1:
  • Hematologic: neutrophils ≥1500/μL, platelets ≥100,000/μL, lymphocytes ≥500/μL, hemoglobin ≥9 g/dL (transfusion and/or erythropoietin not permitted within 2 weeks before blood draw)
  • Renal: estimated glomerular filtration rate ≥45 mL/min/1.73 m2 (Levey 2009)
  • Hepatic: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 x ULN or ≤5 x ULN if liver metastases; coagulation international normalized ratio (INR) and activated partial thromboplastin time (aPTT), ≤1.5 x ULN; serum total bilirubin ≤1.5 x ULN or total bilirubin ≤ULN for patients with total bilirubin >1.5 x ULN (except for elevated bilirubin secondary to Gilberts disease. Confirmation of Gilberts diagnosis requires: elevated unconjugated (indirect) bilirubin values; normal complete blood count (in previous 12 months), blood smear and reticulocyte count; normal transaminases and alkaline phosphatase in previous 12 months.
  • Chemistry: albumin ≥3.0 g/dL at screening
  • Females of childbearing potential, <1-year postmenopause who are not permanently sterile, must have a negative serum pregnancy test (beta-human chorionic gonadotropin [β-HCG]) at baseline (unless they have had a hysterectomy), and agree to use 2 highly effective methods of birth control during the study and for 30 days after the last dose of study intervention. 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 any contraception.
  • Nonchildbearing potential is defined as surgically sterile or postmenopausal (defined as 12 months of spontaneous amenorrhea). A follicle stimulating hormone (FSH) level >40 IU/L at screening will confirm postmenopausal status. If a patient is not sexually active, but becomes active, then she and her male partner must use 2 methods of adequate contraception.
  • 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 30 days after the last dose of study intervention.
  • 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.
  • Must be able to communicate well with Investigator and/or study site personnel and to comply with the requirements of the entire study.

Who cannot join

  • Known history of allergy to any component of study intervention.
  • History of severe allergic/anaphylactic reaction.
  • 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 antiviral therapy at least 4 weeks before screening).
  • Pregnancy and/or lactation
  • Has received a live or live-attenuated vaccine within 28 days before the first dose of study intervention. Note: Administration of killed vaccines and COVID-19 vaccines that are not live or live-attenuated are allowed if >14 days before the first dose.
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  • History of any active infection requiring systemic antibiotics, antivirals or antifungals within 14 days before the first dose of study intervention, including COVID-19 as determined by the currently recommended testing strategy for acute infection.
  • 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 before 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 by the CTCAE V 5.0 criteria (NCI 2017) except for alopecia, peripheral neuropathy, and hypothyroidism secondary to prior checkpoint inhibitor therapy if currently being treated and clinically euthyroid.
  • Receipt of any investigational agent or treatment within a period of 5 half-lives (or 28 days whichever is shorter) before the first dose of study intervention.
  • Any prior immunotherapy or treatment with checkpoint inhibitors, unless approved by the Sponsor, 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 14 days of enrollment, except for local (topical, nasal, or inhaled) steroid use. Limited doses of systemic steroids (eg, in patients with exacerbation of reactive airway disease) must have been 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 except any of the following:
  • Adequately treated basal cell carcinoma, squamous cell carcinoma of the skin, or Stage 0 carcinoma in situ
  • 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
  • Any other cancer from which the patient has been disease-free for ≥2 years
  • Use of biotin (ie 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).
  • Any of the following events within 6 months before baseline Day 1:
  • Myocardial infarction
  • Unstable angina
  • Unstable symptomatic ischemic heart disease
  • New York Heart Association class III or IV heart failure
  • Thromboembolic events (eg, pericardial effusion, restrictive cardiomyopathy, severe untreated valvular stenosis, or severe congenital heart disease)
  • Electrocardiogram QT interval corrected for heart rate (QTc) > 470 msec, measured by Fridericia's formula [QTcF=QT/(RR0.33)]. If the QTc is prolonged in a patient with a pacemaker or bundle branch block, the patient may be enrolled in the study if confirmed by the medical monitor.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Sarcoma Oncology Center

    Santa Monica, California, 90403

Other trials in United States

About this study

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.

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.

Read the 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 establish the Recommended Phase 2 Dose (RP2D) and/or maximum tolerated dose (MTD) with up to 6 dose-escalation groups and to expand the dataset at the maximum achieved dose (MAD) in combination with trabectedin in patients with advanced soft-tissue sarcoma.

Being tested
SON-1010
Keywords
Immunotherapy, Interleukin-12, First-in-human

What participants receive

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

  • SON-1010Biological

    Also called IL12-FHAB

    SON-1010 is a recombinant, single-chain, unmodified human rIL-12 joined by a flexible linker to the fully human albumin binding (FHAB) domain that "hitch-hikes" on serum albumin for transport to the tumor microenvironment.

Study groups in NCT05352750
Study groupRoleWhat they receive
Dose Level 1ExperimentalSON-1010 Dose Level 1
Receives: Biological: SON-1010
Dose Level 2ExperimentalSON-1010 Dose Level 2
Receives: Biological: SON-1010
Dose Level 3ExperimentalSON-1010 Dose Level 3
Receives: Biological: SON-1010
Dose Level 4ExperimentalSON-1010 Dose Level 4
Receives: Biological: SON-1010
Dose Level 5ExperimentalSON-1010 Dose Level 5
Receives: Biological: SON-1010
Dose Level 6ExperimentalSON-1010 Dose Level 6
Receives: Biological: SON-1010
Expansion group using SON-1010 with trabectedin in advanced soft tissue sarcomaExperimentalSON-1010 Dose Level 6 alternating with trabectedin
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

    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

    Highest safe dose achieved during dose escalation

    Measured: Through study completion, an average of 1 year

Secondary outcomes (4)

  1. Serum and urine concentrations of SON-1010 will be determined at various time points

    Concentration vs time of SON-1010 will be measured using blood \& urine samples taken at various time points on study

    Measured: Cycles 1 and 2 (each cycle is 28 days)

  2. Effect of SON-1010 on Serum cytokine levels

    Concentration of serum level of IL-2, IL-6, IL-10 will be measured using blood samples taken at various time points on study

    Measured: Cycles 1 and 2 (each cycle is 28 days)

  3. Evaluation of SON-1010 immunogenicity

    Evaluate the immunogenicity of SON-1010 by measuring the number of patients developing anti-SON-1010 antibodies

    Measured: Cycles 1, 2 and 3 (each cycle is 21 days)

  4. To assess the antitumor activity of SON-1010

    Objective response rate per RECIST 1.1 and iRECIST or other appropriate disease-specific response criteria.

    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 posted29 Apr 2022
  2. Study start20 Apr 2022
  3. Primary completion30 Jun 2026 (estimated)
  4. Study completion30 Jun 2026 (estimated)

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
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Model description
Dose escalation and expansion at the SON-1010 MAD with trabectedin in advanced STS
Masking
None (open label)
Enrolment
42 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05352750
Sponsor's protocol ID
SB101
Status last verified
Jan 2026
First submitted
5 Apr 2022
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 study testing SON-1010 in people with Advanced Solid Tumor and Soft Tissue Sarcoma Adult, run by Sonnet BioTherapeutics at 1 site in United States.

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 17 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: under way, not looking for participants, 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 1 site in United States. 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 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.

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

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

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 (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 NCT05352750.

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.

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