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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NM32-2668 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NM32-2668 | Biological | Anti-ROR1/Anti-Cluster of Differentiation 3 (CD3)/Anti-Human Serum Albumin (HSA) Tri-Specific Antibody |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Dose Limiting Toxicities (DLTs) | Through 28 days post-infusion | |
| 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]) | Through 50 days post-final dose administration | |
| Frequency of dose interruptions/reductions | Up to 12 treatment cycles or through treatment discontinuation, whichever occurs first | |
| Duration of dose interruptions/reductions | Up to 12 treatment cycles or through treatment discontinuation, whichever occurs first |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of the maximum observed serum concentration (Cmax) | From date of randomization until end of treatment, assessed for up to 336 days (i.e., 12 treatment cycles) or through treatment discontinuation | |
| Assessment of the the minimum observed serum concentration (Cmin) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | United States | ||
| USC Norris Comprehensive Cancer Center |
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| From date of randomization until end of treatment, assessed for up to 336 days (i.e., 12 treatment cycles) or through treatment discontinuation |
| Time from dosing at which maximum observed serum concentration is apparent (Tmax) | From date of randomization until end of treatment, assessed for up to 336 days (i.e., 12 treatment cycles) or through treatment discontinuation |
| Assessment of the terminal phase (apparent elimination) rate constant (λz) | From date of randomization until end of treatment, assessed for up to 336 days (i.e., 12 treatment cycles) or through treatment discontinuation |
| Assessment of the elimination half-life (t½) | From date of randomization until end of treatment, assessed for up to 336 days (i.e., 12 treatment cycles) or through treatment discontinuation |
| Assessment of the area under the serum concentration-time curve extrapolated from the last quantifiable concentration to infinity (AUC[0-infinity]) | From date of randomization until end of treatment, assessed for up to 336 days (i.e., 12 treatment cycles) or through treatment discontinuation |
| Assessment of the area under serum concentration-time curve over dosing interval (AUCtau) | From date of randomization until end of treatment, assessed for up to 336 days (i.e., 12 treatment cycles) or through treatment discontinuation |
| Assessment of clearance (CL) of NM32-2668 in serum | From date of randomization until end of treatment, assessed for up to 336 days (i.e., 12 treatment cycles) or through treatment discontinuation |
| Assessment of the volume of distribution (Vd) of NM32-2668 in serum | From date of randomization until end of treatment, assessed for up to 336 days (i.e., 12 treatment cycles) or through treatment discontinuation |
| Assessment of accumulation ratios of Cmax (ARcmax) of NM32-2668 in serum | From date of randomization until end of treatment, assessed for up to 336 days (i.e., 12 treatment cycles) or through treatment discontinuation |
| Assessment of accumulation ratios of Cmin (ARcmin) of NM32-2668 in serum | From date of randomization until end of treatment, assessed for up to 336 days (i.e., 12 treatment cycles) or through treatment discontinuation |
| Assessment of accumulation ratios of AUC (ARauc) of NM32-2668 in serum | From date of randomization until end of treatment, assessed for up to 336 days (i.e., 12 treatment cycles) or through treatment discontinuation |
| Frequency of specific anti-drug antibodies (ADAs) to NM32-2668 | From date of randomization until end of treatment, assessed for up to 336 days (i.e., 12 treatment cycles) or through treatment discontinuation |
| Concentration of specific ADAs to NM32-2668 | From date of randomization until end of treatment, assessed for up to 336 days (i.e., 12 treatment cycles) or through treatment discontinuation |
| Incidence of specific ADAs by category to NM32-2668 | From date of randomization until end of treatment, assessed for up to 336 days (i.e., 12 treatment cycles) or through treatment discontinuation |
| Best Overall Response (BOR) according to RECIST 1.1 | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed for up to 30 days following last dose of study treatment |
| Overall Response Rate (ORR) according to RECIST 1.1 | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed for up to 30 days following last dose of study treatment |
| Disease Control Rate (DCR) according to RECIST 1.1 | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed for up to 30 days following last dose of study treatment |
| Progression-free Survival (PFS) according to RECIST 1.1 | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed through study completion (on average, 1 year after last treatment) |
| Time to Response (TTR) according to RECIST 1.1 | From date of randomization until the date of first documented treatment response according to RECIST 1.1 |
| Duration of Response (DOR) according to RECIST 1.1 | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed through study completion (on average, 1 year after last treatment) |
| Overall Survival (OS) | From date of randomization until the date of death from any cause, assessed through study completion (on average, 1 year after last treatment) |
| Los Angeles |
| California |
| 90033 |
| United States |
| The University of Chicago Medical Center (UCMC) | Chicago | Illinois | 60637 | United States |
| Duke University | Durham | North Carolina | 27710 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| University of Pittsburgh Medical Center (UPMC) - Hillman Cancer Center | Pittsburgh | Pennsylvania | 15232 | United States |
| Lifespan Cancer Institute at Rhode Island Hospital | Providence | Rhode Island | 02903 | United States |
| Medical University of South Carolina (MUSC) | Charleston | South Carolina | 29425 | United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
| Mary Crowley Cancer Research | Dallas | Texas | 75230 | United States |
| Froedtert Hospital and the Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| D005185 | Fallopian Tube Neoplasms |
| D016889 | Endometrial Neoplasms |
| D000077192 | Adenocarcinoma of Lung |
| D064726 | Triple Negative Breast Neoplasms |
| D008080 | Liposarcoma |
| D007890 | Leiomyosarcoma |
| D000086002 | Mesothelioma, Malignant |
| D008545 | Melanoma |
| D002292 | Carcinoma, Renal Cell |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D005184 | Fallopian Tube Diseases |
| D014594 | Uterine Neoplasms |
| D014591 | Uterine Diseases |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D001943 | Breast Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D018205 | Neoplasms, Adipose Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D012509 | Sarcoma |
| D009379 | Neoplasms, Muscle Tissue |
| D008654 | Mesothelioma |
| D000236 | Adenoma |
| D018301 | Neoplasms, Mesothelial |
| D010997 | Pleural Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D007680 | Kidney Neoplasms |
| D014571 | Urologic Neoplasms |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
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