RecruitingPHASE3INTERVENTIONAL

Symbiotic-GI-03: A Study to Learn About the Study Medicine Called PF-08634404 in Combination With Chemotherapy in Adult Participants With Metastatic Colorectal Cancer

This study is looking into a new treatment called PF-08634404 for adults with colorectal cancer that has spread to other parts of the body. The main goal is to find out if this new medicine, when given with standard chemotherapy, works better than another approved cancer medicine, Bevacizumab, also given with chemotherapy. People who join will receive treatment directly into a vein and will be monitored closely. The study aims to help those whose cancer has returned or spread after previous treatments. Participants will be in the study for about 33 months, with regular checks and follow-up to ensure their well-being.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Pfizer

Enrolment target

800

Start

11 Dec 2025

Estimated completion

01 Aug 2031

Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Colorectal Neoplasms

What is this study about?

This study is exploring a new medicine, which we'll call PF-08634404, to treat adults with colorectal cancer that has spread to other parts of the body. Colorectal cancer is a type of cancer that starts in the large bowel (colon or rectum). When cancer has spread, it means it has moved from where it started to other areas of the body.

The main aim of this study is to see if combining this new medicine with chemotherapy (which is a standard cancer treatment) can help people whose cancer has already spread or has come back after they've had other treatments. We want to find out if this new combination works better than another common treatment for this type of cancer, called Bevacizumab, when it's also given with chemotherapy.

By taking part, you could help doctors learn more about how to treat advanced colorectal cancer. This kind of research is very important because it helps us understand which treatments are most effective and can improve care for future patients. All treatments will be given under careful medical supervision.

Key takeaways

This study is for adults with colorectal cancer that has spread.
It tests a new medicine (PF-08634404) with chemotherapy.
Compares the new combination to an existing treatment (Bevacizumab) with chemotherapy.
Participants are randomly assigned to one of two treatment groups.
Treatment and monitoring happen at a study clinic.
The study lasts about 33 months for each person, including follow-up.

Who may be eligible?

To be considered for this study, you need to be at least 18 years old and have colorectal cancer that has spread to other parts of your body. You also need to be in good enough health to safely receive the study treatments, and you should not be pregnant.

There are some reasons why someone might not be able to join. For example, if your cancer has certain genetic changes (like BRAF V600E or MSI-high/dMMR), or if you have specific active brain lesions, you might not be eligible. Also, certain heart conditions, active autoimmune diseases, or recent major surgery could prevent you from taking part.

Your study doctor will carefully review your medical history and test results to see if this study is right for you. They will explain everything clearly, so you can make an informed decision.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have colorectal cancer that has spread to other parts of your body?
Are you generally healthy enough to receive study treatments?
Are you not pregnant?
Have you not had systemic cancer treatment for your metastatic disease before?

Answer every question to see your result.

What does participation involve?

If you join this study, you'll be assigned by chance (like flipping a coin) to one of two treatment groups. You, your family, and your doctors won't know which group you're in. One group will get the new medicine PF-08634404 with standard chemotherapy. The other group will get Bevacizumab (another approved medicine) with standard chemotherapy. All study medicines will be given directly into a vein through an IV line.

Treatment is given in cycles. You can keep receiving the treatment as long as it's helping and you're not having serious side effects. You'll have regular visits to a clinic where medical staff will monitor your health during and after each treatment.

The study is expected to last for about 33 months for each person. This includes regular visits for treatments, health checks, and tests. After you finish treatment, you'll have a final check-up about a month later to review your health and any side effects. You'll then have follow-up contact (by phone, in person, or through your medical records) every 12 weeks to keep track of your health and any new treatments you might be having.

Potential risks and benefits

Taking part in a clinical trial may offer potential benefits, such as gaining access to a new treatment before it's widely available, and your health will be closely monitored by medical professionals. However, there are also potential risks; the new medicine may not work as expected, or it could cause side effects, some of which might be serious. Because you won't know which treatment group you're in, you might receive the established treatment rather than the new one. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (228)

Ironwood Cancer & Research Centers
Verified postcode
Chandler, United States· Recruiting
Ironwood Cancer & Research Centers
Verified postcode
Gilbert, United States· Recruiting
Ironwood Cancer & Research Centers
Verified postcode
Glendale, United States· Recruiting
Ironwood Cancer & Research Centers
Verified postcode
Goodyear, United States· Recruiting
Ironwood Cancer & Research Centers
Verified postcode
Mesa, United States· Recruiting
Ironwood Cancer & Research Centers
Verified postcode
Mesa, United States· Recruiting
Ironwood Cancer & Research Centers
Verified postcode
Phoenix, United States· Recruiting
Ironwood Cancer & Research Centers
Verified postcode
Scottsdale, United States· Recruiting
Highlands Oncology Group
Verified postcode
Fayetteville, United States· Recruiting
Highlands Oncology Group
Verified postcode
Rogers, United States· Recruiting
Highlands Oncology Group
Verified postcode
Springdale, United States· Recruiting
UCSF at Berkeley Outpatient Center
Verified postcode
Berkeley, United States· Recruiting

Common questions

What is colorectal cancer?

Colorectal cancer is a type of cancer that starts in the large bowel, which includes the colon and the rectum.

What does 'cancer has spread' mean?

It means the cancer has moved from where it first started to other parts of your body.

Will I know which treatment I'm getting?

No, neither you nor your doctor will know which of the two treatment groups you're assigned to in this study.

How will I receive the medicine?

All study medicines will be given directly into your vein through an IV line at a clinic.

How long will I be in the study?

Each participant is expected to be part of the study for about 33 months, including treatment periods and follow-up visits.

How to find out more

Pfizer CT.gov Call Center

clinicaltrials.gov_inquiries@pfizer.com 1-800-718-1021 Official trial record

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