TerminatedPhase 1 / Phase 2NCT04442126

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

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.

Checked against the public recordLast updated May 23, 2025 · Source: ClinicalTrials.gov

StatusTerminated
PhasePhase 1 / Phase 2
U.S. locations26
SponsorNumab Therapeutics AG
01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1 / Phase 2
Sponsor
Numab Therapeutics AG
Interventions being studied
Biological: NM21-1480
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

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.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • UCHealth Poudre Valley HospitalFort Collins, Colorado
  • Augusta University Medical CenterAugusta, Georgia
  • Tulane University Medical CenterNew Orleans, Louisiana
  • Henry Ford Health SystemDetroit, Michigan
  • St. Joseph Mercy HospitalYpsilanti, Michigan
  • Dartmouth Cancer CenterLebanon, New Hampshire
  • NYU Langone Medical Center - Perlmutter Cancer Center (NYU Cancer Institute)New York, New York
  • Montefiore Medical CenterThe Bronx, New York
  • Thomas Jefferson UniversityPhiladelphia, Pennsylvania
  • UPMC Hillman Cancer CenterPittsburgh, Pennsylvania
  • Medical University of South Carolina (MUSC)Charleston, South Carolina
  • Sarah Cannon Cancer CenterNashville, Tennessee

Source and freshness
Processed from ClinicalTrials.gov. Last public update: May 23, 2025. Always confirm current availability with the study team.

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