Lung Cancer Clinical Trial

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

Summary

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.

View Eligibility Criteria

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) 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.

Study is for people with:

Lung Cancer

Phase:

Phase 1

Estimated Enrollment:

406

Study ID:

NCT04442126

Recruitment Status:

Recruiting

Sponsor:

Numab Therapeutics AG

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There are 12 Locations for this study

See Locations Near You

Augusta University Medical Center
Augusta Georgia, 30912, United States More Info
Sharad Ghamande
Contact
706-721-2535
[email protected]
Tulane University Medical Center
New Orleans Louisiana, 70112, United States More Info
Mark Sides
Contact
504-988-6121
[email protected]
Henry Ford Health System
Detroit Michigan, 48202, United States More Info
Shirish Gadgeel
Contact
734-647-6883
[email protected]
St. Joseph Mercy Hospital
Ypsilanti Michigan, 48197, United States More Info
Tareq Al Baghdadi
Contact
734-712-1000
[email protected]
Montefiore Medical Center
Bronx New York, 10461, United States More Info
Balazs Halmos
Contact
718-405-8404
[email protected]
NYU Langone Medical Center - Perlmutter Cancer Center (NYU Cancer Institute)
New York New York, 10016, United States More Info
Elaine Shum
Contact
212-731-6363
[email protected]
Thomas Jefferson University
Philadelphia Pennsylvania, 19107, United States More Info
Jennifer Johnson
Contact
215-955-8875
[email protected]
UPMC Hillman Cancer Center
Pittsburgh Pennsylvania, 15232, United States More Info
Jason Luke
Contact
412-623-4511
[email protected]
Medical University of South Carolina (MUSC)
Charleston South Carolina, 29425, United States More Info
Brian Orr
Contact
843-792-1634
[email protected]
Sarah Cannon Cancer Center
Nashville Tennessee, 37203, United States More Info
Melissa L. Johnson, MD
Contact
615-524-4195
[email protected]
The University Of Texas MD Anderson Cancer Center
Houston Texas, 77030, United States More Info
David S Hong, MD
Contact
713-563-7930
[email protected]
Virginia Cancer Specialists
Fairfax Virginia, 22031, United States More Info
Alexander Spira
Contact
703-280-5390
[email protected]
Hospital Universitario de A Coruna
A Coruña , , Spain More Info
Joaquin Mosquera Martine
Contact
34981178000
[email protected]
Hospital General Universitario de Elche
Elche , , Spain More Info
Maria Guirado Risueno
Contact
966616250
[email protected]
Complejo Hospitalario de Jaen
Jaén , , Spain More Info
Ana-Laura Ortega Granados
Contact
953220306
[email protected]
Centro Integral Oncologico Clara Campal
Madrid , , Spain More Info
Maria Jose de Miguel Luken
Contact
917567825
[email protected]
Clinica Universidad de Navarra - Madrid
Madrid , , Spain More Info
Ignacio Melero
Contact
[email protected]
Hospital Universitario Virgen de la Victoria
Málaga , , Spain More Info
Laura Medina Rodriguez
Contact
0034 951 032 250
[email protected]
Hospital Universitario Son Llatzer
Palma De Mallorca , , Spain More Info
Juan Coves Sarto
Contact
[email protected]
Clinica Universidad de Navarra - Pamplona
Pamplona , , Spain More Info
Ignacio Melero
Contact
[email protected]
Hospital Universitario Virgen Macarena
Sevilla , , Spain More Info
David Vicente Baz
Contact
954712941
[email protected]
Hospital Universitari i Politecnic La Fe
Valencia , , Spain More Info
Oscar Juan Vidal
Contact
961245872
[email protected]
National Taiwan University Hospital
Taipei , , Taiwan More Info
James Chih-Hsin Yang, MD, PhD
Contact
02-23123456
[email protected]

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 1

Estimated Enrollment:

406

Study ID:

NCT04442126

Recruitment Status:

Recruiting

Sponsor:


Numab Therapeutics AG

How clear is this clinincal trial information?

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