PF-08634404 + Chemotherapy for Colorectal Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new medicine, PF-08634404, for individuals with colorectal cancer that has spread or returned after previous treatments. The study aims to determine if adding this drug to standard chemotherapy can improve outcomes. Participants will receive either the new drug with chemotherapy or another approved treatment, Bevacizumab, with chemotherapy. Individuals with metastatic colorectal cancer who are in good health might be suitable for this study. As a Phase 3 trial, this study is the final step before potential FDA approval, offering participants the opportunity to contribute to a treatment that could soon become widely available.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Studies have shown that PF-08634404 is generally well-tolerated when combined with chemotherapy for colorectal cancer. Research indicates that most patients handled the treatment without serious side effects. Common reactions included tiredness, nausea, and mild skin issues, which are typical with cancer treatments.
The second treatment option, Bevacizumab, already approved for colorectal cancer, has a well-known safety record. It is usually well-tolerated, though some patients might experience high blood pressure, fatigue, or minor bleeding.
Both treatments involve regular health checks to monitor and manage any side effects that may occur.12345Why do researchers think this study treatment might be promising for colorectal cancer?
Researchers are excited about PF-08634404 for colorectal cancer because it introduces a novel mechanism of action by potentially targeting specific cancer pathways that current treatments do not address. Unlike the standard care options, such as bevacizumab, which primarily inhibit blood vessel growth to the tumor, PF-08634404 might directly interfere with the cancer cell's growth processes. This unique approach could offer a more targeted treatment, possibly leading to better outcomes and fewer side effects.
What evidence suggests that this trial's treatments could be effective for colorectal cancer?
Research has shown that PF-08634404, when combined with chemotherapy, might benefit people with metastatic colorectal cancer. Studies suggest this combination could extend the period during which the cancer does not worsen and improve survival rates. In this trial, participants will receive either PF-08634404 with chemotherapy or Bevacizumab with chemotherapy. Researchers are comparing this new medicine to Bevacizumab, a common treatment, to determine its effectiveness. Early results are promising, indicating that PF-08634404 could be a viable option for those whose cancer has returned or spread after previous treatments.12467
Who Is on the Research Team?
Pfizer CT.gov Call Center
Principal Investigator
Pfizer
Are You a Good Fit for This Trial?
Adults with colorectal cancer that has spread, who are in good health overall and have at least one measurable tumor. They must not be pregnant and should have normal liver and kidney function. The trial is not suitable for those outside these criteria.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either PF-08634404 or Bevacizumab in combination with chemotherapy through IV infusions in cycles
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- PF-08634404
Trial Overview
The study compares a new drug, PF-08634404 combined with standard chemotherapy, against the approved drug Bevacizumab with chemotherapy in metastatic colorectal cancer patients. Treatments are assigned randomly and administered intravenously in cycles.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Participants will receive PF-08634404 intravenously (IV) in combination with Chemotherapy.
Participants will receive bevacizumab IV in combination with Chemotherapy.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Pfizer
Lead Sponsor
Albert Bourla
Pfizer
Chief Executive Officer since 2019
PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki
Patrizia Cavazzoni
Pfizer
Chief Medical Officer
MD from McGill University
Citations
NCT07222800 | A Study to Learn About the ...
The purpose of this study is to learn more about a new medicine called PF-08634404, and how well it works in people with cancer of the colon or rectum ...
2.
s206.q4cdn.com
s206.q4cdn.com/795948973/files/doc_events/2025/Nov/10/PfizerPflash_-4404-SITC-IR-Event-2025_FINAL.pdfPfizer Pflash: A Spotlight on the PF'4404 (SSGJ-707 / PF ...
Global Double-Blind Phase 3 Trial of PF'4404 in First-Line Metastatic Colorectal Cancer. 1:1. Dual Primary Endpoints: PFS by BICR │ OS.
3.
theglobeandmail.com
theglobeandmail.com/investing/markets/stocks/PFE/pressreleases/37022565/pfizers-new-colorectal-cancer-trial-puts-pf-08634404-head-to-head-with-a-market-standard/Pfizer's New Colorectal Cancer Trial Puts PF-08634404 ...
... PF-08634404 can improve outcomes for adults with metastatic colorectal cancer when added to standard chemotherapy. The trial compares the ...
PF-08634404 with Chemotherapy for Metastatic Colorectal Cancer
The study will compare the effectiveness and safety of PF-08634404 combined with standard chemotherapy against another treatment option, Bevacizumab combined ...
5.
trial.medpath.com
trial.medpath.com/clinical-trial/8d2ceb92a2773f64/nct07227298-pf-08634404-combination-anticancer-agents-solid-tumorsA Study to Learn About the Study Medicine Called PF ...
This study is being done to learn more about a new medicine called PF-08634404 and how it works when used with other cancer medicines in ...
Pfizer moves into the VEGF bispecific fast lane | ApexOnco
In NSCLC PF-08634404 is being combined with chemo, and pitted against Keytruda plus chemo – precisely the approach being taken with ivonescimab ...
PF-08634404 / 3SBio, Pfizer - Oncology
A Study to Learn About the Study Medicine Called PF-08634404 in Combination With Chemotherapy in Adult Participants With Metastatic Colorectal Cancer ...
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