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PF-08046876 | B6C is an investigational compound. Its safety and efficacy have not been established.
Active enrolling
United States, Canada, Puerto Rico
for more information at clinicaltrials.gov
EXPERIMENTAL: Part 1 Dose Escalation
Different groups of participants will receive different doses and/or schedules of the study drug
DRUG: PF-08046876
Intravenous administration
EXPERIMENTAL: Part 2 Dose Optimization
Participants will be randomized to 2 dosing regimens deemed to be safe in Part 1
DRUG: PF-08046876
Intravenous administration
EXPERIMENTAL: Part 2 Dose Expansion
Participants in tumor-specific groups will receive 1 dosing regimen deemed to be safe in Part 1
DRUG: PF-08046876
Intravenous administration
Incidence of Treatment Emergent Adverse Events (TEAEs) estimated during the Adverse Events (AE) evaluation
AEs as characterized by type, frequency, severity, timing, seriousness, and relationship to study therapy dose modifications.
Start of treatment up to 30 days after last dose or start of new anticancer therapy (whichever occurs first)
Part 1: Number of Participants With Dose-limiting Toxicities (DLTs): Monotherapy
Occurrence of DLTs as defined by the protocol
Baseline to end of DLT evaluation period
Part 1: Recommended Monotherapy Dose for Expansion
RDE will be based on cumulative safety, preliminary antitumor activity and pharmacokinetics findings
Baseline to 30 days post last study drug administration
Part 2: Recommended Phase 2 Dose
RP2D will be determined based on the cumulative safety, preliminary anti tumor activity and Pharmacokinetics findings.
Baseline to 30 days post last study drug administration
Objective Response Rate (ORR)
ORR defined as per Response Evaluation Criteria in Solid Tumors (RECIST v1.1).
Baseline until the date of the first documentation of disease progression, death, or start of new anticancer therapy (approximately 2 years)
Duration of Response (DOR)
DOR as defined per RECIST 1.1.
From the date of the first objective response to the date of disease progression or death (approximately 2 years)
Progression Free Survival (PFS)
PFS as defined per RECIST 1.1.
From Baseline to date of first disease progression or death (approximately 2 Years)
Overall Survival (OS)
OS defined as the time until death due to any cause.
From baseline to up to 3 years
Pharmacokinetics (PK): Maximum Observed Serum Concentration (Cmax)
Evaluate the single and multiple dose PK of PF-08048676.
Baseline to approximately 30 days after last dose of study drug
PK: Time to Reach Maximum Observed Plasma Concentration (Tmax)
Evaluate the single and multiple dose PK of PF-08048676.
Baseline to approximately 30 days after last dose of study drug
PK: Area Under the Curve (AUC) from Time Zero to Last Quantifiable Concentration (AUClast)
Evaluate the single and multiple dose PK of PF-08048676.
Baseline to approximately 30 days after last dose of study drug
Incidence of Anti-Drug Antibody (ADA)
To evaluate the immunogenicity of PF-08046876.
Baseline to approximately 30 days after last dose of study drug
Incidence of Neutralizing Antibodies (NAb)
To evaluate the immunogenicity of PF-08046876.
Baseline to approximately 30 days after last dose of study drug
Percent change of immune cells within tumors based on multiplex immunofluorescence
This measure will assess changes in the presence or activation of immune cells in the tumor microenvironment using RNA and/or Immunohistochemistry (IHC) assays.
Baseline through 4-7 weeks after first dose of study drug
310
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.
NCT07090499
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