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Trial record 1 of 1 for:    NCT06299163
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NM32-2668 in Adult Patients With Selected Advanced Solid Tumors

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ClinicalTrials.gov Identifier: NCT06299163
Recruitment Status : Recruiting
First Posted : March 7, 2024
Last Update Posted : May 8, 2024
Sponsor:
Information provided by (Responsible Party):
Numab Therapeutics AG

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Ovarian Carcinoma Fallopian Tube Carcinoma Peritoneal Carcinoma Endometrial Cancer Adenocarcinoma of Lung Triple Negative Breast Cancer Liposarcoma Leiomyosarcoma Mesothelioma, Malignant Adenocarcinoma - Gastroesophageal Junction (GEJ) Adenocarcinoma of the Stomach Melanoma, Malignant Renal Cell Carcinoma Biological: NM32-2668 Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: N/A
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Study of NM32-2668 (Anti-ROR1/CD3/Anti-HSA Tri-Specific Antibody) in Adult Patients With Selected Advanced Solid Tumors
Actual Study Start Date : May 1, 2024
Estimated Primary Completion Date : December 31, 2027
Estimated Study Completion Date : December 31, 2027

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Melanoma

Arms and Interventions
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Arm Intervention/treatment
Experimental: NM32-2668 Biological: NM32-2668
Anti-ROR1/Anti-Cluster of Differentiation 3 (CD3)/Anti-Human Serum Albumin (HSA) Tri-Specific Antibody


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of Dose Limiting Toxicities (DLTs) [ Time Frame: Through 28 days post-infusion ]
  2. 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]) [ Time Frame: Through 50 days post-final dose administration ]
  3. Frequency of dose interruptions/reductions [ Time Frame: Up to 12 treatment cycles or through treatment discontinuation, whichever occurs first ]
  4. Duration of dose interruptions/reductions [ Time Frame: Up to 12 treatment cycles or through treatment discontinuation, whichever occurs first ]

Secondary Outcome Measures :
  1. Assessment of the maximum observed serum concentration (Cmax) [ Time Frame: From date of randomization until end of treatment, assessed for up to 336 days (i.e., 12 treatment cycles) or through treatment discontinuation ]
  2. Assessment of the the minimum observed serum concentration (Cmin) [ Time Frame: From date of randomization until end of treatment, assessed for up to 336 days (i.e., 12 treatment cycles) or through treatment discontinuation ]
  3. Time from dosing at which maximum observed serum concentration is apparent (Tmax) [ Time Frame: From date of randomization until end of treatment, assessed for up to 336 days (i.e., 12 treatment cycles) or through treatment discontinuation ]
  4. Assessment of the terminal phase (apparent elimination) rate constant (λz) [ Time Frame: From date of randomization until end of treatment, assessed for up to 336 days (i.e., 12 treatment cycles) or through treatment discontinuation ]
  5. Assessment of the elimination half-life (t½) [ Time Frame: From date of randomization until end of treatment, assessed for up to 336 days (i.e., 12 treatment cycles) or through treatment discontinuation ]
  6. Assessment of the area under the serum concentration-time curve extrapolated from the last quantifiable concentration to infinity (AUC[0-infinity]) [ Time Frame: From date of randomization until end of treatment, assessed for up to 336 days (i.e., 12 treatment cycles) or through treatment discontinuation ]
  7. Assessment of the area under serum concentration-time curve over dosing interval (AUCtau) [ Time Frame: From date of randomization until end of treatment, assessed for up to 336 days (i.e., 12 treatment cycles) or through treatment discontinuation ]
  8. Assessment of clearance (CL) of NM32-2668 in serum [ Time Frame: From date of randomization until end of treatment, assessed for up to 336 days (i.e., 12 treatment cycles) or through treatment discontinuation ]
  9. Assessment of the volume of distribution (Vd) of NM32-2668 in serum [ Time Frame: From date of randomization until end of treatment, assessed for up to 336 days (i.e., 12 treatment cycles) or through treatment discontinuation ]
  10. Assessment of accumulation ratios of Cmax (ARcmax) of NM32-2668 in serum [ Time Frame: From date of randomization until end of treatment, assessed for up to 336 days (i.e., 12 treatment cycles) or through treatment discontinuation ]
  11. Assessment of accumulation ratios of Cmin (ARcmin) of NM32-2668 in serum [ Time Frame: From date of randomization until end of treatment, assessed for up to 336 days (i.e., 12 treatment cycles) or through treatment discontinuation ]
  12. Assessment of accumulation ratios of AUC (ARauc) of NM32-2668 in serum [ Time Frame: From date of randomization until end of treatment, assessed for up to 336 days (i.e., 12 treatment cycles) or through treatment discontinuation ]
  13. Frequency of specific anti-drug antibodies (ADAs) to NM32-2668 [ Time Frame: From date of randomization until end of treatment, assessed for up to 336 days (i.e., 12 treatment cycles) or through treatment discontinuation ]
  14. Concentration of specific ADAs to NM32-2668 [ Time Frame: From date of randomization until end of treatment, assessed for up to 336 days (i.e., 12 treatment cycles) or through treatment discontinuation ]
  15. Incidence of specific ADAs by category to NM32-2668 [ Time Frame: From date of randomization until end of treatment, assessed for up to 336 days (i.e., 12 treatment cycles) or through treatment discontinuation ]
  16. Best Overall Response (BOR) according to RECIST 1.1 [ Time Frame: 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 ]
  17. Overall Response Rate (ORR) according to RECIST 1.1 [ Time Frame: 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 ]
  18. Disease Control Rate (DCR) according to RECIST 1.1 [ Time Frame: 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 ]
  19. Progression-free Survival (PFS) according to RECIST 1.1 [ Time Frame: 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) ]
  20. Time to Response (TTR) according to RECIST 1.1 [ Time Frame: From date of randomization until the date of first documented treatment response according to RECIST 1.1 ]
  21. Duration of Response (DOR) according to RECIST 1.1 [ Time Frame: 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) ]
  22. Overall Survival (OS) [ Time Frame: From date of randomization until the date of death from any cause, assessed through study completion (on average, 1 year after last treatment) ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with histologically confirmed, advanced-stage protocol-specified solid tumors.
  • Confirmed ROR1 tumor expression.
  • Patients who have undergone at least one prior systemic therapy and have radiologically or clinically determined progressive disease during or after most recent line of therapy, and for whom no further standard therapy is available, or who are intolerable or have medical contraindications to standard therapy.

Exclusion Criteria:

  • Prior treatment with any agent targeting ROR1 or prior treatment with a CD3 T-cell engaging therapy.
  • Prior treatment with chimeric antigen receptor (CAR) cell therapy within 90 days prior to first dose of NM32-2668.
  • Systemic anti-neoplastic therapy within five half-lives or 21 days, whichever is shorter, prior to first dose of NM32-2668.
  • Wide-field radiotherapy (> 30% of marrow-bearing bones) within 28 days, or focal radiation for analgesic purpose or for lytic lesions at risk of fracture within 14 days prior to first dose of NM32-2668, or no recovery from side effects of such prior interventions.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06299163


Contacts
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Contact: Martin Stern, MD +41 44 533 2292 clinicaltrials@numab.com

Locations
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United States, California
USC Norris Comprehensive Cancer Center Recruiting
Los Angeles, California, United States, 90033
Contact: Jacob thomas         
Principal Investigator: Jacob thomas         
United States, Ohio
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Contact: Regina Yu         
Principal Investigator: Dale Shepard         
United States, Pennsylvania
University of Pittsburgh Medical Center (UPMC) - Hillman Cancer Center Recruiting
Pittsburgh, Pennsylvania, United States, 15232
Contact: Heather Jandecka         
Principal Investigator: Jason Luke         
United States, Rhode Island
Lifespan Cancer Institute at Rhode Island Hospital Recruiting
Providence, Rhode Island, United States, 02903
Contact: Benedito A. Carneiro, MD         
Principal Investigator: Benedito A. Carneiro, MD         
United States, Texas
Mary Crowley Cancer Research Recruiting
Dallas, Texas, United States, 75230
Contact: Douglas W. Orr, MD         
Principal Investigator: Douglas W. Orr, MD         
Sponsors and Collaborators
Numab Therapeutics AG
More Information
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Responsible Party: Numab Therapeutics AG
ClinicalTrials.gov Identifier: NCT06299163    
Other Study ID Numbers: NB-NM032-2668-101
First Posted: March 7, 2024    Key Record Dates
Last Update Posted: May 8, 2024
Last Verified: March 2024

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma
Melanoma
Adenocarcinoma
Endometrial Neoplasms
Triple Negative Breast Neoplasms
Mesothelioma
Mesothelioma, Malignant
Leiomyosarcoma
Liposarcoma
Adenocarcinoma of Lung
Melanoma, Cutaneous Malignant
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neuroendocrine Tumors
 Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Nevi and Melanomas
Skin Neoplasms
Neoplasms by Site
Skin Diseases
Urogenital Neoplasms
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Uterine Neoplasms
Genital Neoplasms, Female
Uterine Diseases
Genital Diseases, Female