This study will test the safety of a drug called PF-08046054/SGN-PDL1V alone and with pembrolizumab in participants with solid tumors. It will also study the side effects of this drug. A side effect is anything a drug does to your body besides treating your disease.
Participants will have solid tumor cancer that has spread through the body (metastatic) or cannot be removed with surgery (unresectable).
This study will have five parts. Parts A and B of the study will find out how much PF-08046054/SGN- PDL1V should be given to participants. Part C will use the dose found in Parts A and B to find out how safe PF-08046054/SGN-PDL1V is and if it works to treat solid tumor cancers. In Part D and E, participants will be given PF-08046054/SGN-PDL1V with pembrolizumab to find out how safe this combination is and if it works to treat solid tumor cancers.
Participants must have one of the following histologically- or cytologically-confirmed metastatic or unresectable solid tumor types
Non-small cell lung cancer (NSCLC)
Head and neck squamous cell carcinoma (HNSCC) (except nasopharyngeal cancer)
Esophageal squamous cell carcinoma (SCC)
History of another malignancy within 3 years of first dose of study treatment or any evidence of residual disease from a previously diagnosed malignancy.
Are clinically stable for at least 4 weeks prior to study entry after brain metastasis treatment
Have no new or enlarging brain metastases
And are off of corticosteroids prescribed for symptoms associate with brain metastases for at least 7 days prior to first dose of study treatment
Sequential
PF-08046054
DrugGiven into the vein (IV; intravenously)
pembrolizumab
Drug200 mg once every 3 weeks given into the vein (IV; intravenously)
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.
Number of participants with laboratory abnormalities
Number of participants with dose-limiting toxicities (DLTs)
Number of participants with DLTs by dose level
Confirmed objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) by investigator assessment
The proportion of participants with a partial response (PR) or complete response (CR) which is subsequently confirmed per RECIST v1.1 as assessed by the investigator.
Duration of objective response (DOR) per RECIST v1.1 by investigator assessment
The time from the start of the first documentation of objective tumor response (CR or PR that is subsequently confirmed) to the first documentation of PD (per RECIST v1.1 as assessed by the investigator) or to death due to any cause.
Progression-free survival (PFS) per RECIST v1.1 by investigator assessment
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.
Overall survival (OS)
The time from the start of study treatment to death due to any cause.
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