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

Phase 2TerminatedNCT04442126

Numab Therapeutics AG52 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Advanced Solid Tumor Non-small Cell Lung Cancer Colorectal Cancer Squamous Cell Carcinoma Ovarian Carcinoma

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (26)

UCHealth Poudre Valley Hospital

Fort Collins, Colorado, United States

Augusta University Medical Center

Augusta, Georgia, United States

Tulane University Medical Center

New Orleans, Louisiana, United States

Henry Ford Health System

Detroit, Michigan, United States

St. Joseph Mercy Hospital

Ypsilanti, Michigan, United States

Dartmouth Cancer Center

Lebanon, New Hampshire, United States

NYU Langone Medical Center - Perlmutter Cancer Center (NYU Cancer Institute)

New York, New York, United States

Montefiore Medical Center

The Bronx, New York, United States

Thomas Jefferson University

Philadelphia, Pennsylvania, United States

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, United States

...and 16 more locations