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-08046037 is an investigational compound. Its safety and efficacy have not been established.
Active enrolling
United States, Puerto Rico
EXPERIMENTAL: Part 1a
PF-08046037 monotherapy dose escalation
DRUG: PF-08046037
Given into the vein (IV; intravenous)
EXPERIMENTAL: Part 2a
PF-08046037 monotherapy dose optimization
DRUG: PF-08046037
Given into the vein (IV; intravenous)
EXPERIMENTAL: Part 3a
PF-08046037 monotherapy dose expansion
DRUG: PF-08046037
Given into the vein (IV; intravenous)
EXPERIMENTAL: Part 1b
PF-08046037 +sasanlimab dose escalation
DRUG: PF-08046037
Given into the vein (IV; intravenous)
DRUG: sasanlimab
Given under the skin (SQ; subcutaneous)
EXPERIMENTAL: Part 2b
PF-08046037 + sasanlimab dose optimization
DRUG: PF-08046037
Given into the vein (IV; intravenous)
DRUG: sasanlimab
Given under the skin (SQ; subcutaneous)
EXPERIMENTAL: Part 3b
PF-08046037 + sasanlimab dose expansion
DRUG: PF-08046037
Given into the vein (IV; intravenous)
DRUG: sasanlimab
Given under the skin (SQ; subcutaneous)
This study is seeking participants who have the following tumor types and can provide tumor tissue samples as per below. 1. Tumor types * Monotherapy Dose Escalation (Part 1a) and Optimization (Part 2a) cohorts * Advanced or metastatic NSCLC, HNSCC, melanoma, or PDAC * Must have progressive disease following at least 1 prior approved systemic therapy * Monotherapy Dose Expansion (Part 3a) • Advanced or metastatic NSCLC or PDAC * Combination Safety Evaluation (Part 1b) and Dose Optimization (Part 2b) * Advanced or metastatic NSCLC or HNSCC * May be either a) not received prior immunotherapy for the tumor type OR b) relapse/ refractory after prior immunotherapy * Combination Dose Expansion (Part 3b) * Unresectable locally advanced or metastatic HNSCC or NSCLC * Must not have received prior systemic cytotoxic therapy in the locally advanced or metastatic setting (first-line setting) * Must be treatment naïve to any immunotherapy * NSCLC must have PD-L1 expression TPS \>=50% * HNSCC must have PD-L1 expression CPS \>=1 2. Tissue requirement * Part 1 at lower doses: sufficient archival tissue collected within 12 months of enrollment for submission to central laboratory * Part 1 at higher doses: de novo baseline tumor biopsy or archival tissue within 12 months of enrollment * Part 1 backfill: de novo baseline and on-treatment tumor biopsies are required * Part 2 and 3: de novo baseline or archival tissue within 6 months of enrollment * Part 2 and 3: mandatory on-treatment tumor biopsy, if required by sponsor 3. Measurable disease per RECIST v1.1
Participants who meet the following might not be able to participate. 1. History of Grade \>=3 immune mediated AE related to prior immune modulatory therapy and required immunosuppressive therapy 2. Active or prior autoimmune disease that might deteriorate when receiving an immunostimulatory agent 3. History of uveitis within the preceding 6 months 4. Clinically significant Grade \>=3 neurodegenerative disease 5. Grade 3 or higher pulmonary disease unrelated to underlying malignancy 6. Previous exposure to an investigational immunostimulatory antibody conjugate or systemic TLR agonist
Number of participants with adverse events (AEs)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention
Through 30-37 days after the last study treatment, up to approximately 2 years
Number of participants with laboratory abnormalities
Through 30-37 days after the last study treatment, up to approximately 2 years
Number of dose modifications due to AEs
Through end of treatment up to approximately 2 years
Number of participants with dose-limiting toxicities (DLTs)
Up to 21 days
Number of participants with DLTs by dose level
Up to 21 days
Pharmacokinetic (PK) parameter - Area under the concentration-time curve (AUC)
PK endpoint
Through 30-37 days after the last study treatment, up to approximately 2 years
PK parameter - Maximum concentration (Cmax)
PK endpoint
Through 30-37 days after the last study treatment, up to approximately 2 years
PK parameter - Time to maximum concentration (Tmax)
PK endpoint
Through 30-37 days after the last study treatment, up to approximately 2 years
PK parameter - t1/2
PK endpoint
Through 30-37 days after the last study treatment, up to approximately 2 years
PK parameter - Trough concentration (Ctrough)
PK endpoint
Through 30-37 days after the last study treatment, up to approximately 2 years
Number of participants with antidrug antibodies (ADAs)
Through 30-37 days after the last study treatment, up to approximately 2 years
Objective response rate (ORR)
The objective response rate (ORR) is defined as the percentage of participants with complete response (CR) or partial response (PR) which is subsequently confirmed as assessed according to Response Evaluation in Solid Tumors (RECIST) v1.1.
Through end of study and up to approximately 2 years
Best overall response
The best overall response for a participant will be determined by the order of confirmed CR, confirmed PR, stable disease (SD), progressive disease (PD), not evaluable (NE) or not applicable (NA) per RECIST v1.1.
Through end of study and up to approximately 2 years
Duration of response (DOR)
DOR is defined as the time from start of the first documentation of objective tumor response (CR or PR) to the first documentation of tumor progression per RECIST v1.1 or to death due to any cause
Through end of study and up to approximately 2 years
Progression-free survival (PFS)
PFS is defined as the time from start of PF-08046037 to first documentation of disease progression (based on radiographic assessments per RECIST v1.1) or death due to any cause, whichever comes first
Through end of study and up to approximately 2 years
Overall survival (OS)
OS is defined as the time from start of PF-08046037 to date of death due to any cause
Through end of study and up to approximately 2 years
Percent change of cells within tumors based on multiplex immunofluorescence
This measure will assess the number of immune cells, PD-1, PD-L1, and TLR7 expression within the tumor microenvironment.
Through end of study and up to approximately 2 years
399
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.
NCT06974734
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