Status:
TERMINATED
A Study of NM21-1480 in Adult Patients With Advanced Solid Tumors
Lead Sponsor:
Numab Therapeutics AG
Conditions:
Advanced Solid Tumor
Non-small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 19 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 6 2024
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT04442126
Start Date
August 19 2020
End Date
February 6 2024
Last Update
May 23 2025
Active Locations (26)
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1
UCHealth Poudre Valley Hospital
Fort Collins, Colorado, United States, 80524
2
Augusta University Medical Center
Augusta, Georgia, United States, 30912
3
Tulane University Medical Center
New Orleans, Louisiana, United States, 70112
4
Henry Ford Health System
Detroit, Michigan, United States, 48202