Study on Sapanisertib and Serabelisib (PIKTOR) Combinations for HR+/HER2- Advanced/Metastatic Breast Cancer
Sponsor: Faeth Therapeutics
ClinicalTrials ID:NCT07558733
This clinical trial is testing the safety and initial effectiveness of combining the drugs sapanisertib and serabelisib (PIKTOR) with other cancer treatments in patients with advanced or metastatic HR+/HER2- breast cancer.
Patient Parameters
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Program Overview
The purpose of this study is to evaluate how safe and effective the combination of sapanisertib and serabelisib (PIKTOR) is when used with fulvestrant and/or other cancer treatments in patients with advanced or metastatic HR+/HER2- breast cancer. This trial is in Phase 1b/2 and involves multiple centers. It is an open-label study, meaning both the researchers and participants know what treatment is being given. The study will gradually increase the dose to find the safest and most effective dose.
Description
This clinical trial is designed to test the safety and early effectiveness of combining two drugs, sapanisertib and serabelisib (PIKTOR), with fulvestrant and possibly other cancer treatments in patients with advanced or metastatic HR+/HER2- breast cancer. The study is open-label, meaning both the participants and the researchers know which treatments are being administered. The trial will gradually increase the dose of the drugs to determine the safest and most effective dose for patients. Participants will be monitored closely for any side effects and to assess how well the treatment is working against the cancer.
Eligibility Criteria
Inclusion Criteria
- Have a confirmed diagnosis of HR+/HER2- breast cancer.
- Have advanced or recurrent cancer that cannot be treated with surgery or radiation to cure it.
- Have received at least one previous systemic therapy for breast cancer.
- Have at least one tumor that can be measured or evaluated by scans.
- Be in good overall health with an ECOG performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
- Be a non-pregnant, non-lactating female who is postmenopausal, surgically sterile, or agrees to use effective birth control methods.
Exclusion Criteria
- Have triple-negative breast cancer.
- Have cancer that has spread to the brain or spinal cord, unless treated and off steroids for at least 4 weeks.
- Have had another active cancer within the last 24 months, except for certain treated skin cancers or in-situ carcinomas.
- Have conditions affecting the digestive system that might interfere with the absorption of the study drugs.
- Have significant heart problems.
- Have an active, uncontrolled infection.
- Are participating in another clinical trial for treatment.
- Have had radiation therapy within 21 days before starting the study treatment.
- Have previously received certain cancer drugs like PI3K, AKT, or mTOR inhibitors.
- Are taking certain medications that affect how the body processes drugs, or need to take them during the study.
- Have a prolonged QTc interval on an ECG (greater than 480 milliseconds).
- Have Type 1 or Type 2 diabetes that requires insulin.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| START Los Angeles | 90025 | Los Angeles | California |
| Oncology Associates of Oregon | 97477 | Springfield | Oregon |
| SCRI Oncology Partners | 37203 | Nashville | Tennessee |
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