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

Stopped early · Phase 1/Phase 2

Conditions studied: Advanced Solid Tumor, Non-small Cell Lung Cancer, Colorectal Cancer, Squamous Cell Carcinoma, Ovarian Carcinoma, Peritoneal Carcinoma, Fallopian Tube Cancer, Head and Neck Squamous Cell Carcinoma, Triple Negative Breast Cancer

In brief

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.

Key facts

Study ID

NCT04442126

Run by

Numab Therapeutics AG

People needed

52

Starts

2020-08-19

Expected to finish

2024-02-06

Last updated by the study team

2025-05-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• 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
• Medical University of South Carolina (MUSC) — Charleston, South Carolina, United States
• Sarah Cannon Cancer Center — Nashville, Tennessee, United States
• The University Of Texas MD Anderson Cancer Center — Houston, Texas, United States
• Virginia Cancer Specialists — Fairfax, Virginia, United States
• Hospital Universitario de A Coruna — A Coruña, Spain
• Hospital Universitario Vall dHebron — Barcelona, Spain
• Hospital General Universitario de Elche — Elche, Spain
• Complejo Hospitalario de Jaen — Jaén, Spain
• Centro Integral Oncologico Clara Campal — Madrid, Spain
• Clinica Universidad de Navarra - Madrid — Madrid, Spain
• Hospital Universitario Virgen de la Victoria — Málaga, Spain
• Hospital Universitario Son Llatzer — Palma de Mallorca, Spain
• Clinica Universidad de Navarra - Pamplona — Pamplona, Spain
• Hospital Universitario Virgen Macarena — Seville, Spain
• Hospital Universitari i Politecnic La Fe — Valencia, Spain

Full record on ClinicalTrials.gov

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