Clinical trials are voluntary research studies conducted in people designed to find:
This page is not a replacement for the Informed Consent Form or for a discussion of your questions with the study doctor. Participation in any clinical study is completely voluntary.
All clinical studies are required to be reviewed by an independent review board or ethics committee, who helps ensure that the study is safe and appropriately conducted, and the rights and safety of study participants are protected. Clinical trials are conducted by experienced and trained medical professionals, with patient safety and health closely monitored and of top priority.
RecruitingSYNERGY-101 Phase 2 Study in Non-Small Cell Lung Cancer
The SYNERGY-101 study is a Phase 2 clinical research study for adults who have a diagnosis of advanced non-small cell lung cancer (NSCLC) and have not received any treatment for NSCLC. The study will test how well an investigational new drug, STK-012, works in combination with pembrolizumab, pemetrexed, and carboplatin, a standard treatment for NSCLC. “Investigational” means the drug has not been approved by any authority that regulates new medicines, including the FDA.
How STK-012 Works:
STK-012 is an investigational new drug being studied by Synthekine, the sponsor of this study. STK-012 is a modified (changed in the laboratory) form of a protein called interleukin-2 (IL-2) that is normally made by your immune system. STK-012 may help activate your immune system to attack cancer cells.
Contact your treating physician for more information
Additional information is available on www.ClinicalTrials.gov (ID: NCT05098132)
If you participate in this study, you will undergo the following activities:
The ICF contains information about the study including its goals, duration, benefits, risks, tests, and procedures.
You will complete tests to confirm you can join the study. These include review of your medical history and medications, a physical exam, blood and urine tests, heart tests, and CT/MRI scans. Your doctor will review the test results and let you know if you are eligible to join the study.
You will be randomly assigned to 1 of 3 possible treatment groups. All groups will receive standard treatment with pembrolizumab, pemetrexed, and carboplatin given through the vein (intravenously) every 3 weeks (Q3W). Two groups will have STK-012 added to this standard treatment, which means you will have a 2 in 3 chance of receiving STK-012. STK-012 will be given as an injection under the skin (subcutaneously) Q3W.
Treatment groups:
You will receive treatment for as long as you are benefiting from it. The study doctor may interrupt or stop your dosing if side effects occur. While receiving treatment, study tests (like those at Screening) will be performed on a regular basis to monitor you for potential benefits or side effects from study treatment.
If you stop taking treatment, the study team will ask you to complete additional study tests to monitor you for potential benefits or side effects from study treatment. The study team will explain which tests you will receive and the schedule.
Expanded Access Policy
Synthekine Inc. (“Synthekine”) is committed to developing safe and effective medicines designed to improve the treatment of cancer, autoimmune and inflammatory diseases.
In general, all new drug product candidates must be reviewed and approved by the U.S. Food and Drug Administration (“FDA”) before they can become commercially available in the United States for treating appropriate patients. Drugs that have not been approved by FDA may or may not be effective as a treatment and may cause unexpected serious side effects.
As a general policy, Synthekine’s investigational drugs are currently accessible only to subjects participating in a Synthekine-sponsored clinical trial, that is, only to subjects who meet the clinical trial criteria and are enrolled in an ongoing clinical trial. A clinical trial is a controlled research study designed to evaluate whether an investigational drug is safe and effective for its intended use(s). Data generated from clinical trials are then evaluated by FDA to determine whether the investigational drug can be approved for commercialization. We encourage patients who are interested to first discuss with their treating physician about whether participation in a clinical trial is appropriate for them. Whenever possible, Synthekine encourages patients who are eligible for participation in a clinical trial to participate in that trial, which offers the best opportunity for patients to access Synthekine’s investigational drugs before regulatory approval. Additional information about Synthekine’s ongoing clinical trials can be found at https://clinicaltrials.gov and at https://www.synthekine.com/our-pipeline/#pipeline.
However, Synthekine recognizes that some individuals who are not enrolled in a Synthekine-sponsored clinical trial may have a serious or immediately life-threatening disease or condition for which Synthekine is developing an investigational drug and for which the individual may have no satisfactory therapeutic alternatives. In these rare cases, Synthekine may consider providing access to one (or more) of its investigational drugs outside of a Synthekine-sponsored clinical trial to a limited number of physicians who are treating such individuals through a process called “expanded access,” also known as “compassionate use.” Physicians located in the United States may find additional information regarding expanded access to investigational products by visiting FDA’s website at Expanded Access: Information for Physicians. If a treating physician believes expanded access may be an available and appropriate option for their patient, the physician may submit an inquiry for more information on behalf of the patient by contacting Synthekine at clinicaltrials@synthekine.com. Synthekine expects to acknowledge receipt of inquiries within five business days.
Currently, none of Synthekine’s investigational products are available for expanded access.
Pursuant to the 21st Century Cures Act, Synthekine may revise this expanded access policy at any time and the posting of this expanded access policy by Synthekine shall not serve as a guarantee of access to any specific investigational drug for any individual.