nctId: NCT06299163 id: NB-NM032-2668-101 briefTitle: NM32-2668 in Adult Patients With Selected Advanced Solid Tumors overallStatus: RECRUITING date: 2024-03-29 date: 2027-12-31 date: 2027-12-31 date: 2024-03-07 date: 2024-03-07 name: Numab Therapeutics AG class: INDUSTRY 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. 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 studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 180 type: ESTIMATED name: NM32-2668 measure: Incidence of Dose Limiting Toxicities (DLTs) 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]) measure: Frequency of dose interruptions/reductions measure: Duration of dose interruptions/reductions measure: Assessment of the maximum observed serum concentration (Cmax) measure: Assessment of the the minimum observed serum concentration (Cmin) measure: Time from dosing at which maximum observed serum concentration is apparent (Tmax) measure: Assessment of the terminal phase (apparent elimination) rate constant (λz) measure: Assessment of the elimination half-life (t½) measure: Assessment of the area under the serum concentration-time curve extrapolated from the last quantifiable concentration to infinity (AUC[0-infinity]) measure: Assessment of the area under serum concentration-time curve over dosing interval (AUCtau) measure: Assessment of clearance (CL) of NM32-2668 in serum measure: Assessment of the volume of distribution (Vd) of NM32-2668 in serum measure: Assessment of accumulation ratios of Cmax (ARcmax) of NM32-2668 in serum measure: Assessment of accumulation ratios of Cmin (ARcmin) of NM32-2668 in serum measure: Assessment of accumulation ratios of AUC (ARauc) of NM32-2668 in serum measure: Frequency of specific anti-drug antibodies (ADAs) to NM32-2668 measure: Concentration of specific ADAs to NM32-2668 measure: Incidence of specific ADAs by category to NM32-2668 measure: Best Overall Response (BOR) according to RECIST 1.1 measure: Overall Response Rate (ORR) according to RECIST 1.1 measure: Disease Control Rate (DCR) according to RECIST 1.1 measure: Progression-free Survival (PFS) according to RECIST 1.1 measure: Time to Response (TTR) according to RECIST 1.1 measure: Duration of Response (DOR) according to RECIST 1.1 measure: Overall Survival (OS) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Lifespan Cancer Institute at Rhode Island Hospital status: RECRUITING city: Providence state: Rhode Island zip: 02903 country: United States name: Benedito A. Carneiro, MD role: CONTACT name: Benedito A. Carneiro, MD role: PRINCIPAL_INVESTIGATOR lat: 41.82399 lon: -71.41283 facility: Mary Crowley Cancer Research status: RECRUITING city: Dallas state: Texas zip: 75230 country: United States name: Douglas W. Orr, MD role: CONTACT name: Douglas W. Orr, MD role: PRINCIPAL_INVESTIGATOR lat: 32.78306 lon: -96.80667 hasResults: False