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A Study of NM21-1480 in Adult Patients With Advanced Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04442126
Recruitment Status : Recruiting
First Posted : June 22, 2020
Last Update Posted : May 20, 2021
Sponsor:
Information provided by (Responsible Party):
Numab Therapeutics AG

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 Biological: NM21-1480 Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 147 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
Estimated Primary Completion Date : January 7, 2023
Estimated Study Completion Date : June 6, 2023

Resource links provided by the National Library of Medicine


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




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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (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.

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


Contacts
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Contact: Peter Lichtlen, MD, PhD, BBA +41-44-533-22-92 clinicaltrials@numab.com

Locations
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United States, Pennsylvania
UPMC Hillman Cancer Center Recruiting
Pittsburgh, Pennsylvania, United States, 15232
Contact: Sarah Brodeur, BS    412-623-2944    brodeurs@upmc.edu   
United States, Tennessee
Sarah Cannon Cancer Center Recruiting
Nashville, Tennessee, United States, 37203
Contact: Melissa L. Johnson, MD         
United States, Texas
The University Of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: David S Hong, MD    713-563-7930    dshong@mdanderson.org   
Taiwan
National Taiwan University Hospital Recruiting
Taipei, Taiwan
Contact: James Chih-Hsin Yang, MD, PhD         
Sponsors and Collaborators
Numab Therapeutics AG
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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: May 20, 2021
Last Verified: May 2021

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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, Non-Small-Cell Lung
Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases