The safety and efficacy of this agent(s), or use in this setting, has not been established or is subject to confirmation. For an agent(s) whose safety and efficacy has not been established or confirmed, future regulatory approval or commercial availability is not guaranteed.
PF-08046031 | CD228V is an investigational compound. Its safety and efficacy have not been established
Active enrolling
United States, France, Spain, Sweden, United Kingdom
EXPERIMENTAL: PF-08046031 monotherapy
PF-08046031
DRUG: PF-08046031
Given into the vein (IV; intravenous)
Active cerebral/meningeal disease related to the underlying malignancy. Previous exposure to CD228-targeted therapy, vedotin or an MMAE-containing agent, or any taxane containing regimen for advanced disease. Melanoma subtypes including uveal, and mucosal are excluded. Chemotherapy, definitive radiotherapy, biologics, and/or other antitumor treatment with immunotherapy that is not completed 4 weeks prior to first dose of study intervention, or within 2 weeks prior to first dose of study intervention if the underlying disease has progressed on treatment
Other protocol specific criteria might apply.
Number of participants with adverse events (AEs)
Any untoward medical occurrence in a clinical investigational participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
through 30 days after the last study treatment; approximately 6 months
Number of participants with laboratory abnormalities
through 30days after the last study treatment; approximately 6 months
Number of participants with dose limiting toxicities
up to 28 days
number of participants with antidrug antibodies
To be summarized using descriptive statistics
through 30 days after the last study treatment; approximately 6 months
Pharmacokinetic (PK) parameter - Area under the curve (AUC)
To be summarized using descriptive statistics
Through 30 days after the last study treatment; approximately 6 months
PK parameter - Maximum Concentration (Cmax)
To be summarized using descriptive statistics
Through 30 days after the last study treatment; approximately 6 months
PK parameter - Time to maximum concentration (Tmax)
To be summarized using descriptive statistics
Through 30 days after the last study treatment; approximately 6 months
PK parameter - Apparent terminal half-life (t1/2)
To be summarized using descriptive statistics
Through 30 days after the last study treatment; approximately 6 months
PK parameter - Trough concentration (Ctrough)
To be summarized using descriptive statistics
Through 30 days after the last study treatment; approximately 6 months
Objective response rate (ORR)
The proportion of participants with a complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as assessed by the investigato
Up to approximately 1 year
Duration of response (DOR)
The time from start of the first documentation of objective tumor response (CR or PR) to the first documentation of progressive disease (PD) (based on radiographic assessments per RECIST v1.1) or death due to any cause
Up to approximately 1 year
Progression-free survival (PFS)
The time from the start of study treatment to the first documentation of PD (per RECIST v1.1 as assessed by the investigator) or death due to any cause
Up to approximately 1 year
Overall survival (OS)
The time from the start of study treatment to death due to any cause
Approximately 2 years
185
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.
NCT06799533
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