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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05756907




Registration number
NCT05756907
Ethics application status
Date submitted
23/02/2023
Date registered
7/03/2023

Titles & IDs
Public title
Combination of SON-1010 (IL12-FHAB) and Atezolizumab in Patients With Platinum-resistant Ovarian Cancer
Scientific title
A Proof-of-Concept Study to Assess the Combination of SON-1010 (IL12-FHAB) and Atezolizumab in Patients With Platinum-resistant Ovarian Cancer
Secondary ID [1] 0 0
SB221
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced Solid Tumor 0 0
Platinum-resistant Ovarian Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Ovarian and primary peritoneal

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - SON-1010

Experimental: Dose Level 1 - SON-1010 Dose Level 1 + Atezolizumab

Experimental: Dose Level 2 - SON-1010 Dose Level 2 + Atezolizumab

Experimental: Dose Level 3 - SON-1010 Dose Level 3 + Atezolizumab

Experimental: Dose Level 4 - SON-1010 Dose Level 4 + Atezolizumab

Experimental: Dose Level 5 - SON-1010 Dose Level 5 + Atezolizumab

Experimental: RP2D Expansion in Patients with Platinum-resistant Ovarian Cancer - RP2D Dose of SON-1010 + Atezolizumab

Experimental: Randomized Arm #1 in Patients with Platinum-resistant Ovarian Cancer - SON-1010 @ RP2D Alone

Experimental: Randomized Arm #2 in Patients with Platinum-resistant Ovarian Cancer - SON-1010 @ RP2D + Atezolizumab

No intervention: Randomized Arm #3 in Patients with Platinum-resistant Ovarian Cancer - Standard of Care


Treatment: Other: SON-1010
SON-1010 +/- Atezolizumab
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
To evaluate the safety and tolerability of SON-1010 in combination with Atezolizumab
Timepoint [1] 0 0
Through study completion, an average of 1 year
Primary outcome [2] 0 0
To establish the maximum tolerated dose (MTD) of SON-1010 in combination with Atezolizumab
Timepoint [2] 0 0
Through study completion, an average of 1 year
Secondary outcome [1] 0 0
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
Timepoint [1] 0 0
Through study completion, an average of 1 year

Eligibility
Key inclusion criteria
1. Age =18 years at the time of informed consent
2. 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.
3. Eastern Cooperative Oncology Group (ECOG) performance status = 1.
4. Adequate organ and bone marrow function, in the absence of growth factors.
5. Females of childbearing potential, or < 1-year postmenopause who are not permanently sterile, must have a negative serum pregnancy test (beta-human chorionic gonadotropin [ß-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.
6. 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.
7. 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Known history of allergy to any component of study drug or a history of severe allergic/anaphylactic reaction.
2. 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.
3. Infection with HIV-1 or HIV-2 or a history of Kaposi sarcoma and/or Multicentric Castleman Disease.
4. 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)
5. Pregnancy and/or lactation
6. 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.)
7. History of any active infection requiring systemic antibiotics, antivirals or antifungals, including COVID-19, within 14 days before the first dose of study drug.
8. Any acute noninfectious illness not resolved by14 days before day 1.
9. 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
10. 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.
11. 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.
12. Receipt of any investigational agent or treatment within 21 days or 5 half-lives, whichever is shorter, before the first dose of study drug.
13. 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.
14. 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.
15. 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.
16. 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)
17. 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).

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
15/09/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/05/2025
Actual
Sample size
Target
165
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA
Recruitment hospital [1] 0 0
The Border Cancer Hospital - Albury
Recruitment hospital [2] 0 0
Blacktown Mt Druitt Hospital - Blacktown
Recruitment hospital [3] 0 0
Ashford Cancer Centre Research - Kurralta Park
Recruitment postcode(s) [1] 0 0
2640 - Albury
Recruitment postcode(s) [2] 0 0
2148 - Blacktown
Recruitment postcode(s) [3] 0 0
5037 - Kurralta Park
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Sonnet BioTherapeutics
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Hoffmann-La Roche
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Richard T Kenney, MD
Address 0 0
Sonnet BioTherapeutics
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Manuel DaFonseca
Address 0 0
Country 0 0
Phone 0 0
1-609-451-3900
Fax 0 0
Email 0 0
clinical@sonnetbio.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05756907