Study on ST101 for Patients with Advanced Solid Tumors
Sponsor: Sapience Therapeutics
ClinicalTrials ID:NCT04478279
This clinical trial is testing a new drug, ST101, to see if it is safe and effective for treating advanced solid tumors. The study is divided into two parts: finding the right dose and expanding to more patients to see how well it works.
Patient Parameters
| Parameter | Options |
|---|
Program Overview
This study is exploring a new treatment called ST101 for patients with advanced solid tumors that have not responded to other treatments. The trial is in two phases: the first phase aims to find a safe and effective dose, while the second phase will test this dose in more patients to see how well it works. ST101 is given through an IV, and the study will monitor its safety, how the body processes it, and its effects on the tumors.
Description
In the first phase of the study, patients with advanced melanoma, carcinoma, or sarcoma who have not responded to other treatments will receive ST101 through an IV. The dose will start low and gradually increase to find the safest and most effective amount. Patients will be closely monitored for safety after each dose.
In the second phase, the study will focus on specific types of cancer, including hormone receptor-positive breast cancer, melanoma, glioblastoma (GBM), and castration-resistant prostate cancer (CRPC). Patients in this phase will receive the dose found to be most effective in the first phase. The study will look at how well the treatment works in shrinking tumors and improving patient outcomes.
Patients will be evaluated using specific criteria for each type of cancer to measure their response to the treatment. The study may adjust which types of cancer are included based on results from the first phase. Additional small groups of patients may be added if early results show promise.
Eligibility Criteria
Inclusion Criteria
- Must be 18 years or older and able to understand and sign a consent form.
- Have a performance status that allows for daily activities with minimal restrictions.
- Have advanced or metastatic cancer that cannot be surgically removed, including melanoma, carcinoma, or sarcoma for the first phase, and specific types for the second phase.
- Agree to provide a biopsy of the tumor before and during the study.
- Have tried other standard treatments without success or cannot receive them for medical reasons.
- Women of childbearing potential must use effective birth control during and after the study.
- Previous treatment side effects must have resolved to a mild level, except for hair loss.
- Must not have used certain cancer treatments recently before starting the study.
Exclusion Criteria
- Recent use of certain cancer drugs or treatments.
- Allergy to ST101 or its ingredients.
- Heart rhythm issues as shown on an ECG.
- Uncontrolled fluid buildup in the body.
- Active brain metastases or cancer in the brain lining, unless stable and treated.
- Other active cancers needing treatment.
- Active infections like HIV or hepatitis with high viral loads.
- Autoimmune diseases needing systemic treatment, except for certain stable conditions.
- Use of systemic steroids or immunosuppressive drugs recently.
- Blood clotting disorders or recent serious blood clots.
- Medical conditions that could interfere with the study or pose additional risks.
- Unable to comply with study requirements due to mental health or substance abuse issues.
- Pregnant or breastfeeding women, or those planning to conceive during the study.
- Specific exclusions for patients with GBM, such as prior treatments not considered standard for primary GBM.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of California, San Francisco | 94143 | San Francisco | California |
| Sarah Cannon Research Institute | 80218 | Denver | Colorado |
| Northwestern Medicine Cancer Centers | 60555 | Warrenville | Illinois |
| START Midwest | 49503 | Grand Rapids | Michigan |
| Columbia University | 10032 | New York | New York |
| Duke University School of Medicine | 27708 | Durham | North Carolina |
| Sarah Cannon Research Institute | 37203 | Nashville | Tennessee |
Get This Program In Your Inbox
Receive detailed information about this treatment opportunity to review with your healthcare provider.