Study on Combining SON-1010 and Atezolizumab for Patients with Platinum-Resistant Ovarian Cancer
Sponsor: Sonnet BioTherapeutics
ClinicalTrials ID:NCT05756907
This clinical trial is testing a new combination of drugs, SON-1010 and atezolizumab, to see if they are safe and effective for treating patients with advanced solid tumors and specifically those with ovarian cancer that has not responded to platinum-based treatments.
Patient Parameters
| Parameter | Options |
|---|
Program Overview
This study is exploring the safety and effectiveness of a new drug combination, SON-1010 and atezolizumab, for treating advanced solid tumors and platinum-resistant ovarian cancer. The trial is divided into two parts: Part 1 will focus on patients with various advanced solid tumors to determine the best dose of SON-1010 when used with atezolizumab. Part 2 will specifically assess the combination's effectiveness in patients with ovarian cancer that has returned or not responded to platinum-based treatments.
Description
The study aims to find out if SON-1010, when combined with the immunotherapy drug atezolizumab, can be a safe and effective treatment for patients with advanced solid tumors and platinum-resistant ovarian cancer. SON-1010 may work well with atezolizumab, especially in cancers like ovarian cancer that have high levels of a protein called SPARC. The trial will first determine the safest dose of SON-1010 in combination with atezolizumab in patients with advanced solid tumors. Then, it will evaluate if this combination is more effective than SON-1010 alone or the current standard treatments for patients with platinum-resistant ovarian cancer.
Eligibility Criteria
Inclusion Criteria
- Must be 18 years or older.
- Part 1: Must have advanced solid tumors that have not responded to standard treatments and have no other treatment options. Some patients must have platinum-resistant ovarian cancer.
- Part 2: Must have platinum-resistant ovarian cancer, meaning the cancer returned within 6 months after the last platinum treatment. Must have evidence of cancer progression.
- Must be in good overall health with an ECOG performance status of 0 or 1.
- Must have adequate organ and bone marrow function.
- Women of childbearing potential must have a negative pregnancy test and agree to use two effective birth control methods during the study and for 30 days after.
- Men and their female partners must use effective birth control if the female partner is of childbearing potential and must not donate sperm during the study and for 90 days after.
- Must be willing to provide informed consent and comply with study requirements.
Exclusion Criteria
- Known allergy to any study drug components or history of severe allergic reactions.
- Recent hospitalization for bowel obstruction or major surgery within 28 days before starting the study.
- Active liver disease or certain viral infections like hepatitis or HIV.
- Pregnant or breastfeeding women.
- Recent live vaccine within 30 days before starting the study.
- Recent active infection requiring treatment within 14 days before starting the study.
- History of autoimmune diseases, except for certain conditions like vitiligo or controlled thyroid disorders.
- Active brain metastases or cancer spread to the brain lining.
- Unresolved side effects from previous cancer treatments.
- Recent use of investigational drugs or immunotherapy.
- Use of high-dose steroids within 10 days before starting the study.
- Active second cancer, except for certain low-risk cancers.
- Use of high-dose biotin supplements.
- Recent significant heart problems or blood clots within 6 months before starting the study.
Get This Program In Your Inbox
Receive detailed information about this treatment opportunity to review with your healthcare provider.