protocolSection identificationModule nctId: NCT06285097, orgStudyIdInfo id: C5391001, briefTitle: A Study of PF-07820435 as a Single Agent and in Combination in Participants With Advanced Solid Tumors, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-08, primaryCompletionDateStruct date: 2027-01-31, completionDateStruct date: 2028-01-31, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: Pfizer, class: INDUSTRY, descriptionModule 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., conditionsModule 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, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NON_RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 140, type: ESTIMATED, armsInterventionsModule interventions name: PF-07820435, interventions name: Sasanlimab, outcomesModule primaryOutcomes measure: Number of patients with dose limiting toxicities (DLTs) in dose escalation (Part 1A and Part 1B), primaryOutcomes measure: Number of patients with adverse events (AEs), primaryOutcomes measure: Number of patients with clinically significant lab abnormalities, primaryOutcomes measure: Objective response rate (ORR) in Part 2 Expansion, secondaryOutcomes measure: Objective response rate (ORR) in dose escalation (Part 1A and Part 1B), secondaryOutcomes measure: Duration of tumor response, secondaryOutcomes measure: Progression free survival (PFS), secondaryOutcomes measure: Cmax (maximum concentration) of PF-07820435 and its active metabolite, secondaryOutcomes measure: Tmax (time to maximal plasma concentration) of PF-07820435 and its active metabolite, secondaryOutcomes measure: AUClast (area under the curve from time 0 to the last measurable timepoint) of PF-07820435 and its active metabolite, secondaryOutcomes measure: Cmin (minimum concentration) of PF-07820435 and its active metabolite after multiple dosing only, secondaryOutcomes measure: Change from baseline of immune markers within biopsied tumor tissue, secondaryOutcomes measure: Pre-dose trough concentrations of sasanlimab (Part 1B and Part 2), secondaryOutcomes measure: Incidence and titers of ADA and NAb against sasanlimab (Part 1B and Part 2), secondaryOutcomes measure: Cmax of PF-07820435 and its active metabolite under fasted and fed conditions (Part 2 subset) subset of participants in Part 2, secondaryOutcomes measure: Tmax of PF-07820435 and its active metabolite under fasted and fed conditions (Part 2 subset) subset of participants in Part 2, secondaryOutcomes measure: AUC of PF-07820435 and its active metabolite under fasted and fed conditions (Part 2 subset) subset of participants in Part 2, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Corewell Health (reference non-engagement letter), status: NOT_YET_RECRUITING, city: Grand Rapids, state: Michigan, zip: 49503, country: United States, geoPoint lat: 42.96336, lon: -85.66809, locations facility: START Midwest, status: NOT_YET_RECRUITING, city: Grand Rapids, state: Michigan, zip: 49546, country: United States, geoPoint lat: 42.96336, lon: -85.66809, locations facility: National Cancer Center Hospital East, status: NOT_YET_RECRUITING, city: Kashiwa, state: Chiba, zip: 277-8577, country: Japan, geoPoint lat: 35.86224, lon: 139.97732, locations facility: The Cancer Institute Hospital of JFCR, status: NOT_YET_RECRUITING, city: Koto, state: Tokyo, zip: 135-8550, country: Japan, geoPoint lat: 35.66667, lon: 139.81718, locations facility: Hospital Oncologico Dr. Isaac Gonzalez-Martinez, status: RECRUITING, city: Rio Piedras, zip: 00935, country: Puerto Rico, geoPoint lat: 18.39745, lon: -66.04989, locations facility: Pan American Center for Oncology Trials, LLC, status: RECRUITING, city: Rio Piedras, zip: 00935, country: Puerto Rico, geoPoint lat: 18.39745, lon: -66.04989, hasResults: False