Trial Title:
Combination of SON-1010 (IL12-FHAB) and Atezolizumab in Patients With Platinum-resistant Ovarian Cancer
NCT ID:
NCT05756907
Condition:
Advanced Solid Tumor
Platinum-resistant Ovarian Cancer
Conditions: Official terms:
Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
SON-1010
Description:
SON-1010 +/- Atezolizumab
Arm group label:
Dose Level 1
Arm group label:
Dose Level 2
Arm group label:
Dose Level 3
Arm group label:
Dose Level 4
Arm group label:
Dose Level 5
Arm group label:
RP2D Expansion in Patients with Platinum-resistant Ovarian Cancer
Arm group label:
Randomized Arm #1 in Patients with Platinum-resistant Ovarian Cancer
Arm group label:
Randomized Arm #2 in Patients with Platinum-resistant Ovarian Cancer
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)
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 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).
Criteria for eligibility:
Criteria:
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 [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.
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.
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).
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Sarcoma Oncology Center
Address:
City:
Santa Monica
Zip:
90403
Country:
United States
Status:
Recruiting
Contact:
Last name:
Sant P Chawla, MD
Phone:
310-552-9999
Email:
santchawla@sarcomaoncology.com
Contact backup:
Last name:
Victoria S Chua-Alcala, MD
Phone:
310 552 9999
Email:
vchua@sarcomaoncology.com
Investigator:
Last name:
Sant P Chawla, MD
Email:
Principal Investigator
Facility:
Name:
The Border Cancer Hospital
Address:
City:
Albury
Zip:
2640
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Brett Hamilton, MD
Facility:
Name:
Blacktown Mt Druitt Hospital
Address:
City:
Blacktown
Zip:
2148
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Bo Gao, BM, MS, PhD
Email:
bo.gao@health.nsw.gov.au
Facility:
Name:
Ashford Cancer Centre Research
Address:
City:
Kurralta Park
Zip:
5037
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Carolyn Bampton
Start date:
September 15, 2023
Completion date:
May 30, 2025
Lead sponsor:
Agency:
Sonnet BioTherapeutics
Agency class:
Industry
Collaborator:
Agency:
Hoffmann-La Roche
Agency class:
Industry
Source:
Sonnet BioTherapeutics
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05756907
