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PF-08634404 is an investigational compound. Its safety and efficacy have not been established.
Active enrolling
United States, Australia, Japan, Puerto Rico
for more information at clinicaltrials.gov
EXPERIMENTAL: PF-08634404 + Chemotherapy
Participants will receive PF-08634404 intravenously (IV) in combination with Chemotherapy.
DRUG: PF-08634404
Solution for infusion
DRUG: Chemotherapy
Injection for intravenous use
ACTIVE_COMPARATOR: Bevacizumab + Chemotherapy
Participants will receive bevacizumab IV in combination with Chemotherapy.
BIOLOGICAL: Bevacizumab
Injection for intravenous use
DRUG: Chemotherapy
Injection for intravenous use
Participants are excluded from the study if any of the following criteria apply:
Progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) by Blinded Independent Central Review (BICR)
Progression-free survival is defined as the time from the date of randomization to the date of the first documentation of objective progressive disease (PD) assessed by BICR per RECIST 1.1, or death due to any cause, whichever occurs first.
Approximately 4 years
Overall survival (OS)
Overall survival defined as the time from the date of randomization to the date of death due to any cause.
Approximately 4 years
PFS per RECIST 1.1 by investigator assessment
Progression Free Survival (PFS) is defined as the time from the date of randomization to the date of the first documentation of objective PD assessed by investigator per RECIST 1.1, or death due to any cause, whichever occurs first.
Approximately 4 years
Objective Response Rate (ORR) by BICR
The proportion of participants who have a confirmed CR or PR, as best overall response assessed by BICR as per RECIST 1.1.
Approximately 4 years
Objective Response Rate (ORR) by investigator
The proportion of participants who have a confirmed CR or PR, as best overall response assessed by investigator as per RECIST 1.1.
Approximately 4 years
Duration of Response (DOR) by BICR
The time from the first documentation of objective response (CR or PR that is subsequently confirmed) to the date of the first documentation of PD as determined by BICR assessment per RECIST 1.1, or death due to any cause, whichever occurs first.
Approximately 4 years
DOR by investigator
The time from the first documentation of objective response (CR or PR that is subsequently confirmed) to the date of the first documentation of PD as determined by Investigator per RECIST 1.1, or death due to any cause, whichever occurs first.
Approximately 4 years
PFS2 (PFS after next-line therapy) by investigator
PFS2 is defined as the time from the date of randomization to the date of second objective disease progression or death due to any cause, whichever occurs first. Second objective disease progression is PD after the start of subsequent anticancer therapy (excluding curative surgery) as assessed by the investigator.
Approximately 4 years
Number of Participants with Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Through 90 days after the last study intervention; Approximately 4 years
Number of Participants With Clinical Laboratory Abnormalities
Through 90 days after the last study intervention; Approximately 4 years
Pharmacokinetics (PK): Serum concentration of PF-08634404
Approximately 21 months
Immunogenicity: Incidence of positive Anti-Drug Antibody (ADA)
To characterize the immunogenicity of PF-08634404
Approximately 21 months
Mean scores and Change from baseline in the global health status/quality of life (QoL) score on the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)
The EORTC QLQ-C30 is a questionnaire for quantitative measure of health-related quality of life pertinent to participants with a broad range of cancers who are participating in international clinical trials.
Approximately 4 years
Mean score change from baseline in participant reported function and symptoms scales per EORTC QLQ-CR29
The EORTC QLQ-CR29 is a supplemental colorectal cancer-specific module with measures of symptoms associated with colorectal cancer.
Approximately 4 years
Time to definitive deterioration (TTdD) in the global health status/QoL score on the EORTC QLQ-C30
TTdD is defined as the time from date of randomization to first onset of Patient Reported Outcome (PRO) deterioration without subsequent recovery.
Approximately 4 years
Time to definitive deterioration (TTdD) in participant reported function and symptoms per EORTC QLQ-CR29
TTdD is defined as the time from date of randomization to first onset of Patient Reported Outcome (PRO) deterioration without subsequent recovery.
Approximately 4 years
800
Sponsor: Pfizer
Collaborator: None
For more information, call or email the Pfizer Clinical Trial Contact Center:
When calling, please reference this study number:
NCT# stands for National Clinical Trial number. This is a unique identification code given to each clinical trial registered on ClinicalTrials.gov. The format is "NCT" followed by an 8-digit number (for example, NCT00000419). Also called the ClinicalTrials.gov identifier.
NCT07222800
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