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

  • STATUS
    Recruiting
  • participants needed
    102
  • sponsor
    Numab Therapeutics AG
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Updated on 16 February 2024
See if I qualify
cancer
solid tumour
squamous cell carcinoma of head and neck
squamous cell carcinoma
lung cancer
solid tumor
adenocarcinoma
carcinoma
hepatocellular carcinoma
cholangiocarcinoma
urothelial carcinoma
melanoma
non-small cell lung cancer
small cell lung cancer
renal cell carcinoma

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.

Details
Condition Advanced Solid Tumor
Age 18years - 75years
Treatment NM21-1480
Clinical Study IdentifierNCT04442126
SponsorNumab Therapeutics AG
Last Modified on16 February 2024

Eligibility

 Yes No Not Sure

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), Squamous Cell Cancer Head and Neck (SCCHN) and basket cohort consisting of melanoma, gastric or gastro-esophageal junction adenocarcinoma, renal cell carcinoma or urothelial carcinoma with locally advanced or metastatic, non-resectable disease, which has progressed despite treatment with anti-programmed cell death protein (anti-PD-1) or anti-programmed death-ligand 1 (anti-PD-L1) monotherapy or anti-PD1/chemotherapy or anti-PD-L1/chemotherapy
Prior therapy must have been completed at least 4 weeks prior to the administration of the first dose of study drug

Exclusion Criteria

Patient previously had known immediate or delayed hypersensitivity reaction or idiosyncrasy to the excipients
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: Use of other biological drugs (marketed or investigational) for treatment of the current cancer other than anti-PD1, anti-PD-L1, or anti-CTLA-4 directed antibodies
Patient has an active autoimmune disease or a documented history of autoimmune disease
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cancer
solid tumour
squamous cell carcinoma of head and neck
squamous cell carcinoma
lung cancer
solid tumor
adenocarcinoma
carcinoma
hepatocellular carcinoma
cholangiocarcinoma
urothelial carcinoma
melanoma
non-small cell lung cancer
small cell lung cancer
renal cell carcinoma

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