A Phase 1 Study of PF-08046054/SGN-PDL1V in Advanced Solid Tumors
Seagen, a wholly owned subsidiary of Pfizer
Summary
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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 jud…
Interventions
- DrugPF-08046054
Given into the vein (IV; intravenously)
- Drugpembrolizumab
200 mg once every 3 weeks given into the vein (IV; intravenously)
Locations (61)
- University of Alabama at BirminghamBirmingham, Alabama
- University of Alabama at Birmingham, IDS PharmacyBirmingham, Alabama
- University of Alabama at BirminghamBirmingham, Alabama
- University of Alabama at BirminghamBirmingham, Alabama
- Chao Family Comprehensive Cancer Center and Ambulatory CareIrvine, California
- UC Irvine Health - Chao Family Comprehensive Cancer CenterOrange, California