RecruitingPHASE1INTERVENTIONAL

Study of Zanzalintinib in Combination With Immuno-Oncology Agents in Participants With Solid Tumors

This study is for people with various advanced cancers, including kidney, prostate, and some other solid tumours. It's in an early stage (Phase 1), which means researchers are primarily checking that a new drug called zanzalintinib is safe and how well the body handles it, both by itself and when combined with other existing cancer medicines. They also want to see if it helps shrink tumours. This research involves giving different doses of the drug to find the most effective and tolerable amount. Later, it will focus on seeing how well the treatments work in specific types of cancer. It's a way to explore new options for patients when standard treatments haven't worked or aren't suitable.

At a glance

Status

Recruiting

Phase

PHASE1

Sponsor

Exelixis

Enrolment target

1,314

Start

14 Dec 2021

Estimated completion

28 Jun 2030

Renal Cell Carcinoma (RCC)Metastatic Castration-Resistant Prostate Cancer (mCRPC)Urothelial Carcinoma (UC)Solid Tumor Hepatocellular Carcinoma (HCC)Non-small Cell Lung Cancer (NSCLC)Colorectal Cancer (CRC)Head and Neck Squamous Cell Carcinoma (HNSCC)Clear Cell Renal Cell Carcinoma (ccRCC)Non-Clear Cell Renal Cell Carcinoma (nccRCC)

What is this study about?

This research study is looking into a new medicine called zanzalintinib. It's designed for people who have advanced cancer, meaning cancer that has spread or is difficult to treat with standard methods. The study includes several types of cancer, such as kidney, prostate, bladder, liver, and lung cancer, as well as head and neck cancer.

The main goal of this early-stage study (Phase 1) is to understand how safe zanzalintinib is. The research team will also be looking at how your body handles the drug and if it shows any signs of shrinking tumours. They are testing zanzalintinib by itself, and also in combination with other established cancer drugs like nivolumab, ipilimumab, and relatlimab. Combining treatments often aims to be more effective than a single medicine alone.

Initially, small groups of participants will receive different doses of the drug to figure out the best amount that is both effective and has manageable side effects. After this, different groups of patients with specific cancer types will receive the treatment to see how well it works for them. This careful step-by-step approach is standard practice in developing new cancer treatments to ensure they are as safe and helpful as possible.

Key takeaways

This is an early-stage (Phase 1) study for a new cancer drug called zanzalintinib.
It aims to find out if zanzalintinib is safe and how the body handles it, alone and with other drugs.
It's for people with various advanced solid cancers, including kidney, prostate, and lung cancer.
Participants will receive the study medication and have their health and tumour response closely monitored.
Potential benefits include access to a new treatment, but there are also potential risks and side effects.
You can stop participating at any time.

Who may be eligible?

To join this study, you generally need to have an advanced solid tumour, which means cancer that has spread or cannot be removed by surgery. This could include cancers like kidney, prostate, bladder, or lung cancer. You might be eligible if standard treatments are no longer working, are causing difficult side effects, or if there aren't many other treatment options available for your type of cancer.

Different parts of the study focus on specific cancer types. For example, some parts are for people with a type of kidney cancer called clear cell RCC who haven't had prior treatment, or those whose kidney cancer has progressed after certain combination therapies. Other parts are for men with advanced prostate cancer that is resistant to hormone therapy, or specific types of bladder cancer that have progressed after standard chemotherapy.

Generally, you must be 18 years or older. The research team will review your specific medical history and test results in detail to see if the study is the right fit for you.

Quick self-check

Do I have an advanced solid tumour (cancer that has spread or can't be removed)?
Am I experiencing limited options with my current cancer treatments?
Am I 18 years old or older?
Has my doctor confirmed my specific cancer type aligns with the study requirements (e.g., specific kidney or prostate cancer types)?
Am I willing and able to attend regular clinic visits for treatment and check-ups?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

Taking part in this study would involve regular visits to a clinic. During these visits, you would receive the study medication (zanzalintinib, either alone or with other drugs). The team would closely monitor your health through various assessments, including blood tests, physical examinations, and scans to see how your body is reacting to the treatment and if your tumour is responding. The initial phase involves finding the right dose, which might mean changes to your treatment plan early on. The exact duration of your participation would depend on how your body responds to the treatment and the phase of the study you are in. Throughout the study, you would have dedicated medical support and check-ups to manage any side effects.

Potential risks and benefits

Participating in an early-stage study like this offers the potential benefit of accessing new, experimental treatments that are not yet widely available. While there's a chance the treatment could help control your cancer, it's important to remember that it's still being investigated, and there's no guarantee it will be effective for you. Like all medications, zanzalintinib and the combination treatments can have side effects, which could range from mild to serious. The research team will monitor you closely for any unwanted effects and provide care to help manage them. You are always in control and can withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (122)

Exelixis Clinical Site #67
Phoenix, United States· Recruiting
Exelixis Clinical Site #1
Tucson, United States· Recruiting
Exelixis Clinical Site #123
Palo Alto, United States· Recruiting
Exelixis Clinical Site #59
Santa Barbara, United States· Recruiting
Exelixis Clinical Site #87
Littleton, United States· Recruiting
Exelixis Clinical Site #62
New Haven, United States· Recruiting
Exelixis Clinical Site #49
Newark, United States· Active not recruiting
Exelixis Clinical Site #48
Celebration, United States· Recruiting
Exelixis Clinical Site #11
Gainesville, United States· Recruiting
Exelixis Clinical Site #78
Jacksonville, United States· Recruiting
Exelixis Clinical Site #47
Miami, United States· Recruiting
Exelixis Clinical Site #61
Plantation, United States· Recruiting

+110 more sites — see the official record for the full list.

Common questions

What is Zanzalintinib?

It's a new medicine being tested in this study to see if it can help treat advanced cancers. Researchers are studying how it works and if it's safe and effective.

What does 'Phase 1' mean for this study?

Phase 1 means this is an early stage of research. The main focus is on carefully checking the safety of the new drug and finding the right dose, rather than curing the cancer.

Are there different groups in this study?

Yes, there are different groups depending on the type of cancer you have and previous treatments you've received. Some groups test zanzalintinib alone, while others test it with other medicines.

What are 'solid tumours'?

Solid tumours are growths of abnormal cells that typically form a mass. This study is looking at various types of solid tumours, including kidney, prostate, and lung cancer.

Will I know if I'm getting the active drug or a placebo?

This study does not use placebos. Everyone participating will receive zanzalintinib, either by itself or in combination with other active cancer medicines being tested.

How to find out more

Exelixis Clinical Trials

druginfo@exelixis.com 1-888-EXELIXIS (888-393-5494) Official trial record

Always speak to your GP or specialist before deciding to take part in a study.