A Phase 1 interventional study of PF-08046037 and sasanlimab in Carcinoma, Non Small Cell Lung, Carcinoma, Pancreatic Ductal and Malignant Melanoma, sponsored by Pfizer. Terminated at 15 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-23.
Sponsored by Pfizer · Phase 1, Interventional, and Treatment
The purpose of this study is to learn about the safety and the effects of PF-08046037 alone or with sasanlimab for the treatment of certain advanced or metastatic malignancies.
This study is seeking participants who:
Participants will continue to take the study drug(s) until their cancer is no longer responding or if the patient cannot safely take them. The study team will monitor how each participant is doing with the study treatment during regular visits at the study clinic.
6,485 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,630 are open to participants now.
This study's enrollment of 8 is below the median of 62 across 5,211 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.
Browse Carcinoma, Non-Small-Cell Lung studies →Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.
Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
This study is seeking participants who have the following tumor types and can provide tumor tissue samples as per below.
Tumor types
Monotherapy Dose Escalation (Part 1a) and Optimization (Part 2a) cohorts
Monotherapy Dose Expansion (Part 3a)
Combination Safety Evaluation (Part 1b) and Dose Optimization (Part 2b)
Combination Dose Expansion (Part 3b)
Tissue requirement
Participants who meet the following might not be able to participate.
PF-08046037 monotherapy dose escalation
Drug: PF-08046037
PF-08046037 monotherapy dose optimization
Drug: PF-08046037
PF-08046037 monotherapy dose expansion
Drug: PF-08046037
PF-08046037 +sasanlimab dose escalation
Drug: PF-08046037 · Drug: sasanlimab
PF-08046037 + sasanlimab dose optimization
Drug: PF-08046037 · Drug: sasanlimab
PF-08046037 + sasanlimab dose expansion
Drug: PF-08046037 · Drug: sasanlimab
Given into the vein (IV; intravenous)
Also known as: SGN-PDL1iT
Given under the skin (SQ; subcutaneous)
Also known as: PF-06801591
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
Time frame: Through 30-37 days after the last study treatment, up to approximately 2 years
Number of participants with laboratory abnormalities
Time frame: Through 30-37 days after the last study treatment, up to approximately 2 years
Number of dose modifications due to AEs
Time frame: Through end of treatment up to approximately 2 years
Number of participants with dose-limiting toxicities (DLTs)
Time frame: Up to 21 days
Number of participants with DLTs by dose level
Time frame: Up to 21 days
Pharmacokinetic (PK) parameter - Area under the concentration-time curve (AUC)
PK endpoint
Time frame: Through 30-37 days after the last study treatment, up to approximately 2 years
PK parameter - Maximum concentration (Cmax)
PK endpoint
Time frame: Through 30-37 days after the last study treatment, up to approximately 2 years
PK parameter - Time to maximum concentration (Tmax)
PK endpoint
Time frame: Through 30-37 days after the last study treatment, up to approximately 2 years
PK parameter - t1/2
PK endpoint
Time frame: Through 30-37 days after the last study treatment, up to approximately 2 years
PK parameter - Trough concentration (Ctrough)
PK endpoint
Time frame: Through 30-37 days after the last study treatment, up to approximately 2 years
Number of participants with antidrug antibodies (ADAs)
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: Through end of study and up to approximately 2 years
Plan to share: No — Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
This study is terminated, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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