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PF-08634404 is an investigational compound. Its safety and efficacy have not been established.
Active enrolling
Global
for more information at clinicaltrials.gov
EXPERIMENTAL: PF-08634404 + Sigvotatug Vedotin (Part A)
Participants will receive PF-08634404 in combination with Sigvotatug Vedotin.
BIOLOGICAL: PF-08634404
-Concentrate for solution for infusion
BIOLOGICAL: Sigvotatug Vedotin
-Powder for concentrate for solution for infusion. Single use vial
EXPERIMENTAL: PF-08634404 + Combination Agent 1 (Part B)
Participants will receive PF-08634404 in combination with other anticancer agent as per protocol.
BIOLOGICAL: PF-08634404
-Concentrate for solution for infusion
BIOLOGICAL: Combination Agent 1
-Powder for concentrate for solution for infusion. Single use vial.
Number of Participants with Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
AEs as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), timing, seriousness, and relationship to study intervention.
Through 90 days after the last study intervention; Up to approximately 5 years
Phase I: Number of participants with dose limiting toxicity (DLT)
Dose limiting toxicity based on dose limiting toxicity evaluable participants. The number of participants who experienced DLTs during the DLT observation period.
Through 90 days after the last study intervention; Up to approximately 5 years
Phase 2: Confirmed Objective Response Rate (ORR) per RECIST v1.1 by investigator
ORR is defined as the proportion of participants with a Best Overall Response (BOR) of confirmed Complete Response (CR) or confirmed Partial Response (PR) per RECIST v1.1.
Up to approximately 5 Years
Phase I: Confirmed ORR per RECIST v1.1 by investigator
ORR is defined as the proportion of participants with a Best Overall Response (BOR) of confirmed Complete Response (CR) or confirmed Partial Response (PR) per RECIST v1.1.
Up to approximately 5 Years
Disease Control Rate (DCR) per RECIST v1.1 by investigator
DCR by investigator assessment is defined as the proportion of participants with CR or PR with confirmation, or Stable Disease (SD) by investigator assessment per RECIST version 1.1.
Up to approximately 5 years
Duration of Response (DOR) per RECIST v1.1 by investigator
DOR is defined as the time from the first documentation of objective response (CR or PR that is subsequently confirmed) to the date of first documented disease progression per RECIST v1.1 or death due to any cause, whichever occurs first.
Up to approximately 5 years
Progression Free Survival (PFS) per RECIST v1.1 by investigator
Progression-free survival 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 v1.1, or death due to any cause, whichever occurs first.
Up to approximately 5 years
Number of Participants With Clinical Laboratory Abnormalities
Through 90 days after the last study intervention; Up to approximately 5 years
Pharmacokinetics (PK): Serum concentration of PF-08634404 with anticancer agents
To characterize the pharmacokinetics (PK) of PF-08634404 with anticancer agents.
Up to 37 days after the last dose of treatment
Incidence of Anti-Drug Antibody (ADA) against PF-08634404 with anticancer agents
To characterize the immunogenicity of PF-08634404 with anticancer agents.
Up to 37 days after the last dose of treatment
162
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.
NCT07227298
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