Combination of SON-1010 (IL12-FHAB) and Atezolizumab in Patients With Platinum-resistant Ovarian Cancer

NCT 05756907

 

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 advanced solid tumors (Part 1) and patients with Platinum-resistant Ovarian Cancer (Part 2).

Intervention / Treatment 

  • BiologicalSON-1010

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.

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