protocolSection identificationModule nctId: NCT06277219, orgStudyIdInfo id: LAT010-01, briefTitle: A First-in-Human, Phase 1/2 Study of LAT010 in Patients With Advanced Solid Tumors (LIGHTSPEED-1), acronym: LIGHTSPEED-1, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2026-12, completionDateStruct date: 2027-03, studyFirstPostDateStruct date: 2024-02-26, lastUpdatePostDateStruct date: 2024-02-26, sponsorCollaboratorsModule leadSponsor name: Latticon Antibody Therapeutics, Inc, class: INDUSTRY, descriptionModule briefSummary: This is an open-label, multicenter, Phase 1/2, first-in-human (FIH), dose-escalation and cohort-expansion study of LAT010 to evaluate the safety, tolerability, immunogenicity, PK, PD, and antitumor activity in patients with advanced solid tumors. The study consists of 2 parts: Phase 1 dose-escalation and Phase 2 cohort expansion., conditionsModule conditions: Advanced Solid Tumor, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: NON_RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 150, type: ESTIMATED, armsInterventionsModule interventions name: LAT010, interventions name: LAT010 + ICI, outcomesModule primaryOutcomes measure: Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) (Phase 1), primaryOutcomes measure: Incidence of changes in clinical laboratory values (Phase 1), primaryOutcomes measure: Incidence of dose-limiting toxicities (DLTs) (Phase 1), primaryOutcomes measure: Objective response rate (ORR) per RECIST 1.1 (Phase 2), secondaryOutcomes measure: Maximum plasma concentration (Cmax) of LAT010, secondaryOutcomes measure: Area under the plasma concentration-time curve (AUC) of LAT010, secondaryOutcomes measure: Terminal phase half-life (t1/2) of LAT010, secondaryOutcomes measure: Time to maximum concentration of LAT010, secondaryOutcomes measure: Trough concentration of LAT010, secondaryOutcomes measure: Volume of distribution of LAT010, secondaryOutcomes measure: Clearance of LAT010, secondaryOutcomes measure: ADA occurrence and titer in serum, secondaryOutcomes measure: Objective response rate (ORR) per RECIST 1.1 (Phase 1 ), secondaryOutcomes measure: Duration of response (DOR), secondaryOutcomes measure: Disease control rate (DCR), secondaryOutcomes measure: Progression-free survival (PFS), secondaryOutcomes measure: Overall survival (OS), secondaryOutcomes measure: Incidence of AEs and SAEs, otherOutcomes measure: Epigenetic assessment of the proliferation and activation of CD4+ Treg cells, CD8+ T cells, and natural killer (NK) cells., otherOutcomes measure: Optional flow cytometry assessment of the proliferation and activation of CD4+ Treg cells, CD8+ T cells, and NK cells., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Huntsman Cancer Institute, city: Salt Lake City, state: Utah, zip: 84112, country: United States, contacts name: Jeana McKenney, role: CONTACT, phone: 801-213-8414, email: jeana.mckenney@hci.utah.edu, contacts name: Benjamin L Maughan, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.76078, lon: -111.89105, hasResults: False