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

This is an interventional treatment trial for Advanced Solid Tumor focused on measuring Carcinoma, Neoplasms Read More

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.