Registered outcomes11

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

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List	Outcome	Time frame	Description
Primary	Number of Participants with Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)	Through 90 days after the last study intervention; Up to approximately 5 years	AEs as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), timing, seriousness, and relationship to study intervention.
Primary	Phase I: Number of participants with dose limiting toxicity (DLT)	Through 90 days after the last study intervention; Up to approximately 5 years	Dose limiting toxicity based on dose limiting toxicity evaluable participants. The number of participants who experienced DLTs during the DLT observation period.
Primary	Phase 2: Confirmed Objective Response Rate (ORR) per RECIST v1.1 by investigator	Up to approximately 5 Years	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.
Secondary	Phase I: Confirmed ORR per RECIST v1.1 by investigator	Up to approximately 5 Years	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.
Secondary	Disease Control Rate (DCR) per RECIST v1.1 by investigator	Up to approximately 5 years	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.
Secondary	Duration of Response (DOR) per RECIST v1.1 by investigator	Up to approximately 5 years	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.
Secondary	Progression Free Survival (PFS) per RECIST v1.1 by investigator	Up to approximately 5 years	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.
Secondary	Number of Participants With Clinical Laboratory Abnormalities	Through 90 days after the last study intervention; Up to approximately 5 years
Secondary	Pharmacokinetics (PK): Serum concentration of PF-08634404 with anticancer agents	Up to 37 days after the last dose of treatment	To characterize the pharmacokinetics (PK) of PF-08634404 with anticancer agents.
Secondary	Incidence of Anti-Drug Antibody (ADA) against PF-08634404 with anticancer agents	Up to 37 days after the last dose of treatment	To characterize the immunogenicity of PF-08634404 with anticancer agents.
Other	Overall Survival (OS)	Up to approximately 5 years	Overall survival defined as the time from the date of randomization to the date of death due to any cause.

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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