Brief 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 advancedat a late stage, far along solid tumors (Part 1) and patients with Platinum-resistant Ovarian Cancera disease where abnormal cells split without control and spread to other nearby body tissue and/or organs (Part 2).
Intervention / Treatment
- Biological: SON-1010
Inclusion Criteria:
- Age ≥18 years at the time of informed consenta process in which a patient receives detailed information about a procedure or treatment, including its potential risks, benefits, and alternatives. The patient then has the opportunity to understand the information and voluntarily agree to the procedure or treatment.
- 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 recurrenceto occur or happen again of OC within 6-months (180-days) after the last dosethe amount of medication taken of a platinum-containing regimen), including epithelial, fallopian tube, or 1° peritoneal carcinomacancer arising from tissues that line organs. 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 ascitesa buildup of fluid in the abdomen and/or pleural effusionabnormal fluid build-up in the pleural space, which can cause chest pain and breathing difficulties attributed to tumor OR with solid and/or cystic abnormalities on radiographic imagingtests that create detailed images of areas inside the body consistent with recurrent disease that do not meet RECIST 1.1 definitions for target lesions.
- Eastern Cooperative Oncologythe study, diagnosis and treatment of cancer Group (ECOG) performance status ≤ 1.
- Adequate organ and bone marrowsoft, spongy tissue found in bones that makes blood cells 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, hysterectomycomplete or partial removal of the uterus, or bilateralaffecting both sides oophorectomy, or are ≥ 1-year postmenopause) or have a partner who has had a vasectomy do not need to use contraception. A follicle stimulating hormonea chemical substance produced by glands in the endocrine system that regulates various functions in the body (FSH) level > 35 IU/L at screeningtesting for cancer or conditions that can lead to cancer before symptoms appear, also known as cancer 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.