Overview
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.
Eligibility
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.