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

NCT05352750 | Active Not Recruiting Phase 1 FDA Drug

• 1 other identifier: SB101
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Soft Tissue Sarcoma Adult; Advanced Solid Tumor

Keywords

Immunotherapy; Interleukin-12; First-in-human

Outcome Measures

Primary Outcomes (2)

• To evaluate the safety and tolerability of SON-1010

  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

  Highest safe dose achieved during dose escalation

  Through study completion, an average of 1 year

Secondary Outcomes (4)

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

  Cycles 1 and 2 (each cycle is 28 days)

• Effect of SON-1010 on Serum cytokine levels

  Cycles 1 and 2 (each cycle is 28 days)

• Evaluation of SON-1010 immunogenicity

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

• To assess the antitumor activity of SON-1010

  Through study completion, an average of 1 year

Study Arms (7)

Dose Level 1

EXPERIMENTAL

SON-1010 Dose Level 1

Biological: SON-1010

Dose Level 2

EXPERIMENTAL

SON-1010 Dose Level 2

Biological: SON-1010

Dose Level 3

EXPERIMENTAL

SON-1010 Dose Level 3

Biological: SON-1010

Dose Level 4

EXPERIMENTAL

SON-1010 Dose Level 4

Biological: SON-1010

Dose Level 5

EXPERIMENTAL

SON-1010 Dose Level 5

Biological: SON-1010

Dose Level 6

EXPERIMENTAL

SON-1010 Dose Level 6

Biological: SON-1010

Expansion group using SON-1010 with trabectedin in advanced soft tissue sarcoma

EXPERIMENTAL

SON-1010 Dose Level 6 alternating with trabectedin

Biological: SON-1010

Interventions

SON-1010 BIOLOGICAL

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.

Also known as: IL12-FHAB

Dose Level 1; Dose Level 2; Dose Level 3; Dose Level 4; Dose Level 5; Dose Level 6; Expansion group using SON-1010 with trabectedin in advanced soft tissue sarcoma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• 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.

You may not qualify if:

• 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.
• 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:

Sponsors & Collaborators

• Sonnet BioTherapeutics: lead

Study Sites (1)

Sarcoma Oncology Center

Santa Monica, California, 90403, United States

Location

Study Officials

• Richard Kenney, MD

  Sonnet BioTherapeutics

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Dose escalation and expansion at the SON-1010 MAD with trabectedin in advanced STS

Study Record Dates

• First Submitted: April 5, 2022
• First Posted: April 29, 2022
• Study Start: April 20, 2022
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: February 3, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)