Norton Cancer Institute is pioneering cancer clinical trials that bring innovative treatments to local patients. Learn about trials phases, immunotherapy and how our groundbreaking research is transforming cancer care without the burden of travel. Discover how you can access leading-edge treatments close to home.

Published: June 4, 2025

Estimated reading time: 4 minutes

Clinical trials play a vital role in discovering new cancer treatments. Each year, Norton Cancer Institute participates in numerous research studies that help develop better ways to treat cancer.

Understanding clinical trials: The 4 phases

When a new cancer treatment is being developed, it goes through four distinct testing phases before becoming widely available:

Phase 1: Tests safety and dosing in a small group (fewer than 100 people)

• Determines if the treatment is safe
• Identifies what dose can be tolerated without serious side effects

Phase 2: Involves more participants to evaluate:

• How effective the treatment is
• What side effects might occur and how common they are

Phase 3: Includes even more participants over a longer period to:

• Study long-term effects.
• Confirm the treatment works consistently.
• Help the Food and Drug Administration (FDA) decide if the treatment can be approved for public use.

Phase 4: After FDA approval, when required, continues to:

• Study the treatment in wider populations.
• Gather more safety information.
• Explore new uses for the treatment.

By participating in clinical trials, cancer patients can access innovative treatments that aren’t yet widely available.

Norton Cancer Institute’s leadership in Phase 1 trials

Norton Cancer Institute specializes in early-stage clinical trials, particularly Phase 1 studies. These trials represent the leading edge of cancer treatment research.

Patients who join Phase 1 trials:

• Help advance cancer research.
• May access promising new treatments before they’re widely available.
• Receive close monitoring from a specialized research team.

Breakthrough treatments being studied include:

Immunotherapy

Norton Cancer Institute researchers are studying treatments that help your immune system fight cancer, including:

• Specialized antibodies that target specific immune pathways
• Cell therapies that reprogram immune cells to attack cancer
• Cancer vaccines that teach the body to recognize cancer cells
• Targeted drug combinations that deliver treatment directly to tumors

Treatments like pembrolizumab, nivolumab and CAR T-cell therapy already have shown remarkable success in certain cancers.

Precision medicine

Today’s cancer treatment can be tailored to each person’s unique genetic makeup. Norton Cancer Institute uses advanced genetic testing to:

• Match patients with treatments most likely to work for their specific cancer.
• Reduce unnecessary side effects.
• Target specific molecules that drive cancer growth.

Early detection

Better imaging and screening technologies help doctors find cancer earlier, when treatment is often more effective.

Making advanced cancer care local

Norton Cancer Institute brings leading-edge clinical trials to our community. This means:

• Local patients can access treatments previously only available at major national centers.
• Families avoid the financial burden and stress of traveling far from home.
• Our community benefits from the latest advances in cancer care.

Milestone achievement in 2024

In 2024, Norton Cancer Institute made history as the first health care organization worldwide to treat a patient with a brand-new cancer medication in a first-in-human clinical trial. This groundbreaking ONC-841 trial studies a new intravenous treatment for advanced solid tumors that have spread beyond their original location.

“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. “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 demonstrates how personalized medicine — treatments designed for each person’s unique genetic profile — can improve effectiveness while reducing side effects, offering new hope to cancer patients.

“As we reflect on this achievement 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.”