PF-08634404 with Chemotherapy for Metastatic Colorectal Cancer
PF-08634404
+ Chemotherapy
+ Bevacizumab
Colonic Diseases+13
+ Colonic Neoplasms
+ Digestive System Diseases
Treatment Study
Summary
Study start date: December 12, 2025
Actual date on which the first participant was enrolled.This study aims to evaluate a new medication called PF-08634404 in people with advanced colorectal cancer, which is cancer of the colon or rectum that has spread to other parts of the body. The study will compare the effectiveness and safety of PF-08634404 combined with standard chemotherapy against another treatment option, Bevacizumab combined with chemotherapy. The participants will be individuals who are at least 18 years old, have metastatic colorectal cancer, and are healthy enough to undergo the treatment. This research is important as it seeks to find a potentially more effective treatment option for patients whose cancer has progressed despite previous treatments. Participants will be randomly assigned to receive either PF-08634404 with chemotherapy or Bevacizumab with chemotherapy. Neither the participants nor the doctors will know which treatment is being administered to maintain objectivity. All medications will be given through IV infusions at a clinical site, where medical staff will carefully monitor participants. Treatments will be given in cycles, and participants will continue as long as they benefit and tolerate the treatment well. The study will last up to 33 months per participant, with regular health checks and tests at the study site. After the treatment ends, there will be a follow-up visit 30 to 37 days later, and ongoing follow-ups every 12 weeks to monitor health and any new treatments.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.800 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: * Histological or cytological confirmed colorectal adenocarcinoma. * Evidence of Stage IV metastatic disease. * Eastern Cooperative Oncology Group performance status (ECOG) 0-1 * At least one measurable lesion according to RECIST 1.1 per Investigator assessment. * Adequate hepatic, liver, and renal function Exclusion Criteria: Participants are excluded from the study if any of the following criteria apply: * Locally confirmed BRAF V600E mutation * Locally confirmed microsatellite instability (MSI)-high or DNA mismatch repair deficiency (dMMR) colorectal cancer * Participants with known active symptomatic CNS lesions, including leptomeningeal metastasis, brainstem, meningeal, or spinal cord metastases or compression * Clinically significant risk of hemorrhage or fistula * Major surgery or severe trauma within 4 weeks prior to the first dose, or planned major surgery during the study * History of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation * Any Grade ≥3 bleeding/hemorrhage events within 28 days of Cycle 1 Day 1, or prior history of clinically significant bleeding events * Clinically significant cardiovascular disease, or other comorbidities, within 6 months prior to first dose * Participants with active autoimmune diseases requiring systemic treatment within the past 2 years * Evidence of non-infectious or drug-induced interstitial lung disease (ILD) pneumonitis
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
Active ComparatorStudy Objectives
Primary Objectives
Secondary Objectives