Clinical Trials /

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

NCT04442126

Description:

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.

Related Conditions:
  • Adenocarcinoma of the Gastroesophageal Junction
  • Gastric Adenocarcinoma
  • Head and Neck Squamous Cell Carcinoma
  • Malignant Solid Tumor
  • Melanoma
  • Non-Small Cell Lung Carcinoma
  • Renal Cell Carcinoma
  • Urothelial Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

  • Brief Title: A Study of NM21-1480 in Adult Patients With Advanced Solid Tumors
  • 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

Clinical Trial IDs

  • ORG STUDY ID: NB-ND021 (NM21-1480)-101
  • NCT ID: NCT04442126

Conditions

  • Advanced Solid Tumor

Interventions

DrugSynonymsArms
NM21-1480NM21-1480 Treatment arm

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
NM21-1480 Treatment armExperimental
  • NM21-1480

Eligibility 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), 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.
      
Maximum Eligible Age:75 Years
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time Frame:Up to 3 years
Safety Issue:
Description:Frequency and severity of adverse events

Details

Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Numab Therapeutics AG

Last Updated

June 19, 2020