protocolSection identificationModule nctId: NCT06299163, orgStudyIdInfo id: NB-NM032-2668-101, briefTitle: NM32-2668 in Adult Patients With Selected Advanced Solid Tumors, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-29, primaryCompletionDateStruct date: 2027-12-31, completionDateStruct date: 2027-12-31, studyFirstPostDateStruct date: 2024-03-07, lastUpdatePostDateStruct date: 2024-03-07, sponsorCollaboratorsModule leadSponsor name: Numab Therapeutics AG, class: INDUSTRY, descriptionModule briefSummary: This is a first-in-human, open-label, multi-center, Phase 1, dose-escalation study with expansion cohorts to evaluate NM32-2668 for safety and immunogenicity, to determine the maximal tolerated dose and recommended Phase 2 dose, define the pharmacokinetics, to explore the pharmacodynamics, and to obtain preliminary evidence of the clinical activity in adult patients with selected advanced solid tumors., conditionsModule conditions: Ovarian Carcinoma, conditions: Fallopian Tube Carcinoma, conditions: Peritoneal Carcinoma, conditions: Endometrial Cancer, conditions: Adenocarcinoma of Lung, conditions: Triple Negative Breast Cancer, conditions: Liposarcoma, conditions: Leiomyosarcoma, conditions: Mesothelioma, Malignant, conditions: Adenocarcinoma - Gastroesophageal Junction (GEJ), conditions: Adenocarcinoma of the Stomach, conditions: Melanoma, Malignant, conditions: Renal Cell Carcinoma, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 180, type: ESTIMATED, armsInterventionsModule interventions name: NM32-2668, outcomesModule primaryOutcomes measure: Incidence of Dose Limiting Toxicities (DLTs), primaryOutcomes measure: Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) as assessed by CTCAE v5.0 / ASTCT (for Cytokine Release Syndrome [CRS]), primaryOutcomes measure: Frequency of dose interruptions/reductions, primaryOutcomes measure: Duration of dose interruptions/reductions, secondaryOutcomes measure: Assessment of the maximum observed serum concentration (Cmax), secondaryOutcomes measure: Assessment of the the minimum observed serum concentration (Cmin), secondaryOutcomes measure: Time from dosing at which maximum observed serum concentration is apparent (Tmax), secondaryOutcomes measure: Assessment of the terminal phase (apparent elimination) rate constant (λz), secondaryOutcomes measure: Assessment of the elimination half-life (t½), secondaryOutcomes measure: Assessment of the area under the serum concentration-time curve extrapolated from the last quantifiable concentration to infinity (AUC[0-infinity]), secondaryOutcomes measure: Assessment of the area under serum concentration-time curve over dosing interval (AUCtau), secondaryOutcomes measure: Assessment of clearance (CL) of NM32-2668 in serum, secondaryOutcomes measure: Assessment of the volume of distribution (Vd) of NM32-2668 in serum, secondaryOutcomes measure: Assessment of accumulation ratios of Cmax (ARcmax) of NM32-2668 in serum, secondaryOutcomes measure: Assessment of accumulation ratios of Cmin (ARcmin) of NM32-2668 in serum, secondaryOutcomes measure: Assessment of accumulation ratios of AUC (ARauc) of NM32-2668 in serum, secondaryOutcomes measure: Frequency of specific anti-drug antibodies (ADAs) to NM32-2668, secondaryOutcomes measure: Concentration of specific ADAs to NM32-2668, secondaryOutcomes measure: Incidence of specific ADAs by category to NM32-2668, secondaryOutcomes measure: Best Overall Response (BOR) according to RECIST 1.1, secondaryOutcomes measure: Overall Response Rate (ORR) according to RECIST 1.1, secondaryOutcomes measure: Disease Control Rate (DCR) according to RECIST 1.1, secondaryOutcomes measure: Progression-free Survival (PFS) according to RECIST 1.1, secondaryOutcomes measure: Time to Response (TTR) according to RECIST 1.1, secondaryOutcomes measure: Duration of Response (DOR) according to RECIST 1.1, secondaryOutcomes measure: Overall Survival (OS), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Lifespan Cancer Institute at Rhode Island Hospital, status: RECRUITING, city: Providence, state: Rhode Island, zip: 02903, country: United States, contacts name: Benedito A. Carneiro, MD, role: CONTACT, contacts name: Benedito A. Carneiro, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.82399, lon: -71.41283, locations facility: Mary Crowley Cancer Research, status: RECRUITING, city: Dallas, state: Texas, zip: 75230, country: United States, contacts name: Douglas W. Orr, MD, role: CONTACT, contacts name: Douglas W. Orr, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 32.78306, lon: -96.80667, hasResults: False