Clinical research, including clinical trials, is crucial to advancing the science of cancer care.Norton Cancer Institute contributes to this with dozens of clinical trials every year.
Clinical research, including clinical trials, is a crucial component to advancing the discovery of cancer therapeutics. Norton Cancer Institute contributes to this advancement through participation in numerous clinical trials every year.
4 phases of clinical trial
There are four phases in a clinical trial, each with a different purpose. This helps researchers answer different questions on safety, efficacy, dosage and optimal use.
The phases in a clinical trial regulated by the U.S. Food and Drug Administration (FDA) are:
Phase 1: Typically, a small population of fewer than 100 participants is involved, and the purpose is to evaluate how safe the drug is and what dose of the drug can be safely tolerated.
Phase 2: A greater number of participants helps determine how effective the drug is and how common and serious side effects may be.
Phase 3: This phase involves a larger number of participants and typically lasts for a longer period. In this phase, participants are followed longer to help determine what the longer-term effects of the drug may be and whether the therapy is meaningfully effective. During Phase 3, the FDA will decide whether the drug can be marketed to the public.
Phase 4: The goal is to expand the drug to other populations or diseases by increasing how the drug can be marketed, by gathering more safety data.
Patients with cancer who volunteer for research have access to innovative treatments and techniques that may not be available to those not participating in research studies. Healthy patients serve as controls.
Refer a patient
To refer a patient to Norton Cancer Institute Clinical Trials, visit NortonEpicCareLink.com and open an order for Clinical Trial.
Focus on Phase 1
Norton Cancer Institute’s Phase 1 clinical trial program oversees solid tumor Phase 1 trials as well as any solid tumor trials requiring Institutional Biosafety Committee review.
Early phase and Phase 1 oncology clinical trials involve the initial stages of testing new cancer treatments. These trials asses the safety, dosage and side effects of new drugs or therapies. Participants play a crucial role in advancing cancer research and may gain access to leading-edge and new treatments not yet available to the public, while being closely monitored by a specialized group of researchers.
Norton Cancer Institute’s portfolio of Phase 1 clinical trials is robust, offering patients access to innovative treatments through programs at the forefront of personalized and targeted cancer treatment.
Immunotherapy techniques have reshaped Norton Cancer Institute’s approach to cancer treatment. Immunotherapy treatment modalities include approaches such as monoclonal antibodies targeting different immune inhibitory and activation pathways, cellular therapies, cancer vaccines, antibody drug and radioisotope conjugates and T-cell engagers. Therapies such as checkpoint inhibitors, which target immune inhibitory pathways, including pembrolizumab, nivolumab and atezolizumab, have demonstrated remarkable efficacy across various cancer types, including melanoma, lung cancer, bladder cancer and Hodgkin lymphoma. Additionally, CAR T-cell therapy has shown remarkable success in treating certain types of blood cancers, particularly acute lymphoblastic leukemia (ALL) and diffuse large B-cell lymphoma (DLBCL), offering a potential cure for patients who have exhausted standard treatment options. Furthermore, cancer vaccines have demonstrated effective stimulation of the immune system to recognize and target cancer cells, providing a promising avenue for personalized cancer treatment. These advancements in immunotherapy have shown remarkable success in activating the body’s immune system to target and destroy cancer cells, offering new hope and extended survival to many.
Precision medicine has emerged as a powerful tool in Norton Cancer Institute’s arsenal against cancer. Advancements in genomics, proteomics and other molecular technologies enable us to tailor treatments to the specific genetic and molecular profiles of individual patients, resulting in improved outcomes and reduced toxicity, compared with traditional chemotherapy.
Targeted therapies have revolutionized the treatment landscape by identifying specific molecular targets driving cancer growth. Drugs like tyrosine kinase inhibitors, poly-ADP ribose polymerase (PARP) inhibitors and hormone therapies have demonstrated efficacy across various cancer types, providing new treatment options for patients with specific genetic alterations.
Early detection advancements, powered by innovations in imaging technologies and screening programs, have enabled clinicians to diagnose tumors at earlier stages, leading to improved outcomes for patients with various cancers.
Shaping the future of cancer care
By engaging in these leading-edge studies, Norton Cancer Institute not only contributes significantly to the development of new cancer therapies but also provides its patients with early access to some of the most promising treatments in oncology today. Many of these trials were available at bigger centers, such as MD Anderson or Cleveland Clinic, but now with our expanded portfolio of clinical trials, our patients can access these studies locally. This has a significant impact on our communities and patients, as cancer care and travel related to these trials can be overwhelming for patients and their families and can result in a significant financial burden. This comprehensive approach enhances the institute’s reputation as a leader in cancer research and care, offering hope and potential breakthroughs for patients facing challenging diagnoses.
2024 Notable Accomplishments
In 2024,Norton Cancer Institute became the first health care organization in the world to dose a patient with a first-in-human Phase 1 clinical trial medication for treatment of solid tumors under the sponsorship of OncoC4 Inc., a late-stage biopharmaceutical company developing novel medicines for cancer and immunological diseases. The Phase 1 ONC-841 clinical trial (NCT06352359) will study the medicine given by IV infusion to patients with advanced/metastatic solid tumors, meaning various types of cancer that have spread beyond the cancer’s primary site, with a goal of reducing the tumor size and slowing the spread.
Principal investigator: Tianhong Li, M.D., Ph.D., UC Davis Comprehensive Cancer Center, Sacramento, California
Site investigator: John T. Hamm, M.D., Norton Cancer Institute
“Through cancer research, we’ve witnessed a profound transformation in patient care,” said John T. Hamm, M.D., thoracic medical oncologist with Norton Cancer Institute. “We’ve embraced the forefront of medical science, challenging the boundaries of what was once deemed impossible. These trials are not just a glimpse into the future; they are a testament to the dedication of our researchers, clinicians, and, most important, our patients.”
This program showcases the power of personalized medicine, where treatments are tailored to the unique genetic makeup of the individual. This precision approach not only enhances efficacy but also minimizes adverse effects, offering renewed hope and a better quality of life to those facing the challenges of cancer treatment.
“As we reflect on the achievement of this program and the advancements made in cancer research, we recognize the profound impact of research on combating cancer,” Dr. Hamm said. “Let us extend our efforts to reach new heights of innovation and compassion in the service of those who entrust us with their care.”
