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Trial record 1 of 1 for:    04442126
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A Study of NM21-1480 in Adult Patients With Advanced Solid Tumors

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ClinicalTrials.gov Identifier: NCT04442126
Recruitment Status : Terminated (A business decision was made to discontinue further enrollment. There were no safety concerns that contributed to this decision.)
First Posted : June 22, 2020
Last Update Posted : February 28, 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 1/2, dose-escalation study with expansion cohorts to evaluate NM21-1480 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
Advanced Solid Tumor Non-small Cell Lung Cancer Colorectal Cancer Squamous Cell Carcinoma Ovarian Carcinoma Peritoneal Carcinoma Fallopian Tube Cancer Head and Neck Squamous Cell Carcinoma Triple Negative Breast Cancer Biological: NM21-1480 Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: N/A
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1/2 Study of NM21-1480 (Anti-PDL-1/Anti-4-1BB/Anti-HSA Tri-Specific Antibody) in Adult Patients With Advanced Solid Tumors
Actual Study Start Date : August 19, 2020
Actual Primary Completion Date : February 6, 2024
Actual Study Completion Date : February 6, 2024

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Arms and Interventions
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Arm Intervention/treatment
Experimental: NM21-1480 Treatment arm Biological: NM21-1480
Trispecific anti-PD-L1/anti-4-1BB/anti-Human Serum Albumin (HSA) single-chain Fv fusion protein


Outcome Measures
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Primary Outcome Measures :
  1. Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 [ Time Frame: Up to 3 years ]
    Frequency and severity of adverse events

  2. Maximum Tolerated Dose (MTD) of NM21-1480 [ Time Frame: Up to 3 years ]
    To determine the MTD of NM21-1480

  3. Determination of Phase 2 dose of NM21-1480 [ Time Frame: Up to 3 years ]
    To determine the recommended Phase 2 dose of NM21-1480 for Part B of the study

  4. To determine the anti-tumor activity (Best Overall Response) of NM21-1480 according to RECIST 1.1 [ Time Frame: Up to 3 years ]
  5. To determine the anti-tumor activity (Overall Response Rate) of NM21-1480 according to RECIST 1.1 [ Time Frame: Up to 3 years ]

Secondary Outcome Measures :
  1. Assessment of the maximum observed serum concentration determined by direct inspection of the concentration versus time data (Cmax) [ Time Frame: Up to 3 years ]
  2. Assessment of the the minimum observed serum concentration determined by direct inspection of the concentration versus time data (Cmin) [ Time Frame: Up to 3 years ]
  3. Assessment of the time from dosing at which Cmax is apparent determined by direct inspection of the concentration versus time data (Tmax) [ Time Frame: Up to 3 years ]
  4. Assessment of the terminal phase (apparent elimination) rate constant (λz) [ Time Frame: Up to 3 years ]
  5. Assessment of the elimination half-life (t½) [ Time Frame: Up to 3 years ]
  6. Assessment of the area under the serum concentration-time curve extrapolated from the last quantifiable concentration to infinity (AUC[0-infinity]) [ Time Frame: Up to 3 years ]
  7. Assessment of the area under serum concentration-time curve over dosing interval (AUCtau) [ Time Frame: Up to 3 years ]
  8. Assessment of the clearance (CL) [ Time Frame: Up to 3 years ]
  9. Assessment of the volume of distribution (Vd) [ Time Frame: Up to 3 years ]
  10. Assessment of the frequency of specific anti-drug antibodies to NM21-1480 [ Time Frame: Up to 3 years ]
  11. To determine the anti-tumor activity (Disease Control Rate) of NM21-1480 according to RECIST 1.1 [ Time Frame: Up to 3 years ]
  12. To determine the anti-tumor activity (Duration of Response) of NM21-1480 according to RECIST 1.1 [ Time Frame: Up to 3 years ]
  13. To determine the anti-tumor activity (Time-to-response) of NM21-1480 according to RECIST 1.1 [ Time Frame: Up to 3 years ]
  14. To determine the anti-tumor activity (Progression-free survival) of NM21-1480 according to RECIST 1.1 [ Time Frame: Up to 3 years ]
  15. To determine the anti-tumor activity (Overall Survival) of NM21-1480 according to RECIST 1.1 [ Time Frame: Up to 3 years ]

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:

Part A

  • Patients with any previously treated solid tumor-type other than hepatocellular carcinoma or intrahepatic cholangiocarcinoma that is advanced, or recurrent and progressing since last anti-tumor therapy, and for which no alternative, standard therapy exists.
  • Prior chemotherapy, radiation therapy or immunotherapy must have been completed at least 4 weeks prior to the administration of the first dose of study drug, and patient has recovered

Part B:

  • Patients with Non-small Cell Lung Cancer (NSCLC) or other protocol specified solid tumors with locally advanced or metastatic, non-resectable disease, which has progressed despite treatment with first-line standard of-care treatment, or first- and second-line treatment, dependent on expansion cohort.
  • Prior therapy must have been completed 2-4 weeks prior to the administration of the first dose of study drug as specified per protocol according to type of prior therapy

Exclusion Criteria:

  • Patient previously had known immediate or delayed hypersensitivity reaction or idiosyncrasy to the excipients
  • Part A: Treatment with any PD-1, or Cytotoxic T-Lymphocyte Associated Protein (CTLA)-4 directed antibody, or with any other immunotherapy within 4 weeks prior to initiation of the study drug.
  • Part A: Use of other biological investigational drugs (drugs not marketed for any indication), including use of investigational drugs targeting CD137/4-1BB within at least 5 half-lives (or within 8 weeks, whatever is longer) prior to the administration of the first dose of study drug.
  • Part B: As defined per protocol for each expansion cohort, has not been treated with specified first/second-line standard-of-care therapies biological drugs (marketed or investigational) for treatment of the current cancer, or has not adequately recovered from AEs that occurred with prior therapy.
  • Patient has an active autoimmune disease or a documented history of autoimmune disease.
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): NCT04442126


Locations
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Sponsors and Collaborators
Numab Therapeutics AG
More Information
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Responsible Party: Numab Therapeutics AG
ClinicalTrials.gov Identifier: NCT04442126    
Other Study ID Numbers: NB-ND021 (NM21-1480)-101
2020-0355 ( Other Identifier: MDACC Protocol ID )
First Posted: June 22, 2020    Key Record Dates
Last Update Posted: February 28, 2024
Last Verified: February 2024

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Numab Therapeutics AG:
Carcinoma
Neoplasms
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Squamous Cell
Triple Negative Breast Neoplasms
Fallopian Tube Neoplasms
Squamous Cell Carcinoma of Head and Neck
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms by Site
Neoplasms, Squamous Cell
Breast Neoplasms
Breast Diseases
 Skin Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Fallopian Tube Diseases
Adnexal Diseases
Genital Diseases, Female
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Genital Diseases
Head and Neck Neoplasms