Actively Recruiting
Phase 1 Study to Test Safety of PF-08046054 Alone and With Pembrolizumab in Advanced Solid Tumors
Led by Seagen, a wholly owned subsidiary of Pfizer · Updated on 2026-07-22
714
Participants Needed
62
Research Sites
52 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and side effects of the drug PF-08046054SGN-PDL1V alone and in combination with pembrolizumab in participants with advanced solid tumors. These tumors are either metastatic, meaning they have spread through the body, or unresectable, meaning they cannot be removed by surgery. The study is a Phase 1 trial designed to find the best dose and assess safety and potential treatment effects in these cancers. The study has five parts Parts A and B focus on determining the appropriate dose of PF-08046054SGN-PDL1V. Part C uses the dose found to further evaluate safety and potential effectiveness of the drug alone. Parts D and E study the combination of PF-08046054SGN-PDL1V with pembrolizumab, given intravenously, to assess safety and possible benefits. Pembrolizumab is administered at 200 mg every three weeks. Participants will undergo assessments for side effects, laboratory abnormalities, and dose-limiting toxicities over about one month initially, with follow-up for up to three years to monitor longer-term outcomes like tumor response and survival. Safety monitoring includes tracking adverse events and immune responses to the drug. The study involves regular evaluations to measure tumor changes using standard criteria and to understand how the drugs behave in the body over time.
CONDITIONS
Brief Title
A Study of PF-08046054/SGN-PDL1V in Advanced Solid Tumors
Research Team
S
Seagen Pfizer CT.gov Call Center
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