Study of STK-012 Alone and With Other Treatments for Advanced Lung Cancer and Other Cancers
Sponsor: Synthekine
ClinicalTrials ID:NCT05098132
This clinical trial is testing a new drug, STK-012, both by itself and with other standard treatments, to see if it can help treat advanced lung cancer and other solid tumors. The study is currently open for patients with a specific type of lung cancer that has not been treated before.
Patient Parameters
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Program Overview
This study is exploring a new treatment called STK-012 for patients with advanced cancers. In the first part, researchers tested different doses of STK-012 alone and with other treatments to find the best dose. Now, in the second part, they are testing STK-012 combined with standard cancer treatments to see if it works better than the standard treatments alone for patients with a specific type of lung cancer that hasn't been treated yet.
Description
The study is divided into two phases. The first phase, which is now closed, involved testing different doses of STK-012 alone and with other treatments to find the best dose for future studies. The second phase, which is open for enrollment, is comparing the effectiveness of STK-012 combined with standard treatments (pembrolizumab, pemetrexed, and carboplatin) against the standard treatments alone in patients with a specific type of lung cancer. This phase is focused on patients who have not received any prior treatment for their advanced lung cancer and whose tumors do not have certain genetic markers.
Eligibility Criteria
Inclusion Criteria
- Have a diagnosis of non-small cell lung cancer (NSCLC).
- Cancer is at Stage IV or Stage IIIB/IIIC and cannot be treated with surgery or radiation.
- Cancer type is non-squamous (NSQ) cell.
- Have not received any prior treatment for advanced/metastatic NSQ NSCLC.
- Tumor is PD-L1 negative, meaning it has less than 1% of a specific protein.
- No known genetic changes in the cancer that can be treated with available standard therapies.
Exclusion Criteria
- Have previously received treatments that target the immune system, like anti-PD(L)1 or anti-CTLA-4.
- Tumor has small cell, neuroendocrine, or sarcomatoid components.
- Have received radiation therapy within 7 days before starting the study treatment.
- Have untreated cancer that has spread to the brain.
- Have a history of cancer spreading to the lining of the brain or spinal cord.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of Arizona Cancer Center | 85721 | Tucson | Arizona |
| Beverly Hills Cancer Center | 90211 | Beverly Hills | California |
| Providence Medical Foundation | 92835 | Fullerton | California |
| UC San Diego Moores Cancer Center | 92093-0698 | La Jolla | California |
| Hoag Memorial Hospital Presbyterian | 92663 | Newport Beach | California |
| UCLA Hematology/Oncology - Santa Monica | 90404 | Santa Monica | California |
| Yale New Haven Hospital, Yale Cancer Center | 06510 | New Haven | Connecticut |
| Georgetown University | 20057 | Washington D.C. | District of Columbia |
| Winship Cancer Institute, Emory University | 30322 | Atlanta | Georgia |
| Massachusetts General Hospital | 02114 | Boston | Massachusetts |
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