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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

Tracking Information
First Submitted Date  ICMJE June 18, 2020
First Posted Date  ICMJE June 22, 2020
Last Update Posted Date February 28, 2024
Actual Study Start Date  ICMJE August 19, 2020
Actual Primary Completion Date February 6, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 13, 2023)
  • 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
  • Maximum Tolerated Dose (MTD) of NM21-1480 [ Time Frame: Up to 3 years ]
    To determine the MTD of NM21-1480
  • 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
  • To determine the anti-tumor activity (Best Overall Response) of NM21-1480 according to RECIST 1.1 [ Time Frame: Up to 3 years ]
  • To determine the anti-tumor activity (Overall Response Rate) of NM21-1480 according to RECIST 1.1 [ Time Frame: Up to 3 years ]
Original Primary Outcome Measures  ICMJE
 (submitted: June 19, 2020)
  • 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
  • Maximum Tolerated Dose (MTD) of NM21-1480 [ Time Frame: Up to 3 years ]
    To determine the MTD of NM21-1480
  • 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
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 13, 2023)
  • Assessment of the maximum observed serum concentration determined by direct inspection of the concentration versus time data (Cmax) [ Time Frame: Up to 3 years ]
  • 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 ]
  • 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 ]
  • Assessment of the terminal phase (apparent elimination) rate constant (λz) [ Time Frame: Up to 3 years ]
  • Assessment of the elimination half-life (t½) [ Time Frame: Up to 3 years ]
  • 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 ]
  • Assessment of the area under serum concentration-time curve over dosing interval (AUCtau) [ Time Frame: Up to 3 years ]
  • Assessment of the clearance (CL) [ Time Frame: Up to 3 years ]
  • Assessment of the volume of distribution (Vd) [ Time Frame: Up to 3 years ]
  • Assessment of the frequency of specific anti-drug antibodies to NM21-1480 [ Time Frame: Up to 3 years ]
  • To determine the anti-tumor activity (Disease Control Rate) of NM21-1480 according to RECIST 1.1 [ Time Frame: Up to 3 years ]
  • To determine the anti-tumor activity (Duration of Response) of NM21-1480 according to RECIST 1.1 [ Time Frame: Up to 3 years ]
  • To determine the anti-tumor activity (Time-to-response) of NM21-1480 according to RECIST 1.1 [ Time Frame: Up to 3 years ]
  • To determine the anti-tumor activity (Progression-free survival) of NM21-1480 according to RECIST 1.1 [ Time Frame: Up to 3 years ]
  • To determine the anti-tumor activity (Overall Survival) of NM21-1480 according to RECIST 1.1 [ Time Frame: Up to 3 years ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of NM21-1480 in Adult Patients With Advanced Solid Tumors
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • 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
Intervention  ICMJE Biological: NM21-1480
Trispecific anti-PD-L1/anti-4-1BB/anti-Human Serum Albumin (HSA) single-chain Fv fusion protein
Study Arms  ICMJE Experimental: NM21-1480 Treatment arm
Intervention: Biological: NM21-1480
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: February 26, 2024)		 52
Original Estimated Enrollment  ICMJE
 (submitted: June 19, 2020)		 102
Actual Study Completion Date  ICMJE February 6, 2024
Actual Primary Completion Date February 6, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain,   Taiwan,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04442126
Other Study ID Numbers  ICMJE NB-ND021 (NM21-1480)-101
2020-0355 ( Other Identifier: MDACC Protocol ID )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Numab Therapeutics AG
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Numab Therapeutics AG
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Numab Therapeutics AG
Verification Date February 2024

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP