nctId: NCT06285097 id: C5391001 briefTitle: A Study of PF-07820435 as a Single Agent and in Combination in Participants With Advanced Solid Tumors overallStatus: RECRUITING date: 2024-02-08 date: 2027-01-31 date: 2028-01-31 date: 2024-02-29 date: 2024-04-04 name: Pfizer class: INDUSTRY briefSummary: This study aims to evaluate the safety, and early signals of anti-tumor activity of PF-07820435 when administered alone (Part 1A) or in combination with sasanlimab (Part 1B; Part 2) in patients with selected advanced or metastatic solid tumors. Part 1 will be dose-finding and Part 2 of the study will further evaluate PF-07820435 at the recommended dose for combination expansion in patients with selected advanced solid tumors. conditions: Neoplasms conditions: Non-small-cell Lung Cancer conditions: Melanoma conditions: Squamous Cell Carcinoma of the Head and Neck conditions: Renal Cell Carcinoma conditions: Urothelial Carcinoma conditions: Colorectal Carcinoma conditions: Ovarian Carcinoma studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 140 type: ESTIMATED name: PF-07820435 name: Sasanlimab measure: Number of patients with dose limiting toxicities (DLTs) in dose escalation (Part 1A and Part 1B) measure: Number of patients with adverse events (AEs) measure: Number of patients with clinically significant lab abnormalities measure: Objective response rate (ORR) in Part 2 Expansion measure: Objective response rate (ORR) in dose escalation (Part 1A and Part 1B) measure: Duration of tumor response measure: Progression free survival (PFS) measure: Cmax (maximum concentration) of PF-07820435 and its active metabolite measure: Tmax (time to maximal plasma concentration) of PF-07820435 and its active metabolite measure: AUClast (area under the curve from time 0 to the last measurable timepoint) of PF-07820435 and its active metabolite measure: Cmin (minimum concentration) of PF-07820435 and its active metabolite after multiple dosing only measure: Change from baseline of immune markers within biopsied tumor tissue measure: Pre-dose trough concentrations of sasanlimab (Part 1B and Part 2) measure: Incidence and titers of ADA and NAb against sasanlimab (Part 1B and Part 2) measure: Cmax of PF-07820435 and its active metabolite under fasted and fed conditions (Part 2 subset) subset of participants in Part 2 measure: Tmax of PF-07820435 and its active metabolite under fasted and fed conditions (Part 2 subset) subset of participants in Part 2 measure: AUC of PF-07820435 and its active metabolite under fasted and fed conditions (Part 2 subset) subset of participants in Part 2 sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Corewell Health (reference non-engagement letter) status: NOT_YET_RECRUITING city: Grand Rapids state: Michigan zip: 49503 country: United States lat: 42.96336 lon: -85.66809 facility: START Midwest status: NOT_YET_RECRUITING city: Grand Rapids state: Michigan zip: 49546 country: United States lat: 42.96336 lon: -85.66809 facility: National Cancer Center Hospital East status: NOT_YET_RECRUITING city: Kashiwa state: Chiba zip: 277-8577 country: Japan lat: 35.86224 lon: 139.97732 facility: The Cancer Institute Hospital of JFCR status: NOT_YET_RECRUITING city: Koto state: Tokyo zip: 135-8550 country: Japan lat: 35.66667 lon: 139.81718 facility: Hospital Oncologico Dr. Isaac Gonzalez-Martinez status: RECRUITING city: Rio Piedras zip: 00935 country: Puerto Rico lat: 18.39745 lon: -66.04989 facility: Pan American Center for Oncology Trials, LLC status: RECRUITING city: Rio Piedras zip: 00935 country: Puerto Rico lat: 18.39745 lon: -66.04989 hasResults: False