A Phase 1 Study of PF-08046054/SGN-PDL1V in Advanced Solid Tumors
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.
• Parts A and B:
‣ 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)
∙ Triple negative breast cancer (TNBC)
⁃ Participants must have disease that is relapsed or refractory, that has progressed on approved therapies, be intolerant to or refused such therapies, or such and therapies are contraindicated and in the judgement of the investigator, should have no appropriate SoC therapeutic option
⁃ Participants must have PD-L1 expression based on historical testing
• Part C:
‣ Participants must have disease that is relapsed or refractory or be intolerant to SoC therapies and must have one of the following tumor types
• HNSCC
⁃ Participants with HNSCC must have histologically or cytologically-confirmed HNSCC
∙ NSCLC
⁃ Participants must have histologically or cytologically-confirmed NSCLC. Participants with SCC and non--SCC histology are eligible. Note: Participants with a neuroendocrine component or histology are not eligible.
∙ Esophageal SCC
∙ Ovarian cancer
∙ Melanoma
∙ TNBC
∙ Gastric cancer
⁃ Participants must have been previously tested for PD-L1 expression and should have PD-L1 expression ≥1 or \<1 by CPS or TPS based on historical testing
• Part D and Part E:
‣ Participants must have histologically or cytologically-confirmed disease of the HNSCC or NSCLC
⁃ Participants must have PD-L1 expression based on historical testing
⁃ Participants with NSCLC; PD-L1 expression ≥ 1% by TPS
⁃ Participants with HNSCC; PD--L1 expression ≥1 by CPS
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
• Measurable disease per RECIST v1.1 at baseline